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    Clinical Trial Results:
    A multicentre international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease

    Summary
    EudraCT number
    		 2017-002971-24
    Trial protocol
    		 DE   GB   IT  
    Global end of trial date

    Results information
    Results version number
    		 v2(current)
    This version publication date
    07 Feb 2025
    First version publication date
    16 Jul 2023
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    1245-0137
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03594110
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 18002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 18002430127, clintriage.rdg@boehringer-ingelheim.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
    Interim
    Date of interim/final analysis
    09 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jul 2022
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The primary aim of this trial was to assess the effect of empagliflozin on time to kidney disease progression or cardiovascular (CV) death. Key secondary aims were to assess the effect of empagliflozin on time to hospitalisation for heart failure (HHF) or CV death, occurrences of hospitalisations from any cause, and time to death from any cause.
    Protection of trial subjects
    Only participants that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All participants were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of participants was adhered to throughout the trial conduct. An independent data monitoring committee assessed participant safety and the progress of the trial through review of unblinded data at specified intervals.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 488
    Country: Number of subjects enrolled
    China: 986
    Country: Number of subjects enrolled
    Germany: 1269
    Country: Number of subjects enrolled
    Italy: 246
    Country: Number of subjects enrolled
    Japan: 612
    Country: Number of subjects enrolled
    Malaysia: 646
    Country: Number of subjects enrolled
    United Kingdom: 1133
    Country: Number of subjects enrolled
    United States: 1229
    Worldwide total number of subjects
    6609
    EEA total number of subjects
    1515
    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)
    3003
    From 65 to 84 years
    3473
    85 years and over
    133

    Subject disposition

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    Recruitment
    Recruitment details
    		 Prior to randomisation, potentially eligible participants entered a placebo run-in period for about 8-12 weeks. Thereafter, the participants were to receive treatment with empagliflozin or placebo until approximately 1070 first primary outcome events had occurred after randomisation (i.e. event-driven).

    Pre-assignment
    Screening details
    		 Subjects were screened for eligibility prior to participation and attended a specialist site which ensured that they (the subjects) met all inclusion and none of the exclusion criteria. 8266 subjects were screened in this trial. Population of Trial Subjects tables are based on the Randomised set.

    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, Carer, Data analyst, Assessor
    Blinding implementation details
    Participants, investigators and everyone involved in trial conduct or analysis or with any other interest in this double-blind trial (apart from the Data Monitoring Committee (DMC)) remained blinded with regard to the randomised treatment assignments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matching empagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet once daily.

    Arm title
    		 Empagliflozin 10 mg
    Arm description
    		 Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Empagliflozin
    Investigational medicinal product code
    Other name
    Jardiance®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of 10 milligram (mg) once daily.

    Number of subjects in period 1
    		Placebo Empagliflozin 10 mg
    Started
    3305
    3304
    Treated
    3305
    3304
    Completed
    2457
    2549
    Not completed
    848
    755
         Adverse event, serious fatal
    130
    121
         Participant concerned about study treatment
    23
    28
         Adverse event, non-fatal
    119
    116
         Cannot attend clinic because of personal problems
    8
    16
         Contraindicated drug started
    32
    18
         Cannot attend clinic due to moving out of the area
    15
    9
         Study drug stopped, reason missing
    336
    294
         Doctor advice
    38
    40
         Other (any category with <20 patients in total)
    58
    45
         Participants' wish
    89
    68

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.

    Reporting group title
    Empagliflozin 10 mg
    Reporting group description
    		 Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.

    Reporting group values
    		 Placebo Empagliflozin 10 mg Total
    Number of subjects
    		 3305 3304 6609
    Age categorical
    Randomised set (RS) included all randomised participants, whether treated or not.
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 1502 1501 3003
        From 65-84 years
    		 1744 1729 3473
        85 years and over
    		 59 74 133
    Age Continuous
    Randomised set (RS) included all randomised participants, whether treated or not.
    Units: years
        arithmetic mean (standard deviation)
    		 63.3 ( 13.9 ) 63.4 ( 13.9 ) -
    Sex: Female, Male
    Randomised set (RS) included all randomised participants, whether treated or not.
    Units: Participants
        Female
    		 1095 1097 2192
        Male
    		 2210 2207 4417
    Ethnicity (NIH/OMB)
    Randomised set (RS) included all randomised participants, whether treated or not.
    Units: Subjects
        Hispanic or Latino
    		 119 103 222
        Not Hispanic or Latino
    		 723 708 1431
        Unknown or Not Reported
    		 2463 2493 4956
    Race/Ethnicity, Customized
    Randomised set (RS) included all randomised participants, whether treated or not.
    Units: Subjects
        White
    		 1920 1939 3859
        Black/ African-American
    		 134 128 262
        Asian
    		 1199 1194 2393
        Other including mixed race
    		 52 43 95

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.

    Reporting group title
    Empagliflozin 10 mg
    Reporting group description
    		 Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.

    Primary: Interventional part: Time to first occurrence of kidney disease progression or cardiovascular death (‘as adjudicated’)

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    End point title
    		 Interventional part: Time to first occurrence of kidney disease progression or cardiovascular death (‘as adjudicated’)
    End point description
    Incidence rate of first occurrence of kidney disease progression (KDP) or adjudicated cardiovascular death is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) was not estimable due to insufficient events being experienced. Incidence rate= (Number of patients who experienced the event of first occurrence of KDP or cardiovascular death)*100/(patient years at risk (pt-yrs at risk). pt-yrs at risk= sum of time at risk [days] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: - end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR - a sustained decline in estimated glomerular filtration rate (eGFR) to <10 mL/min/1.73m^2 OR - renal death OR - a sustained decline of ≥40% in eGFR from randomisation.
    End point type
    Primary
    End point timeframe
    Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days.
    End point values
    		 Placebo Empagliflozin 10 mg
    Number of subjects analysed
    3305 [1]
    3304 [2]
    Units: patients with events/100 pt-yrs at risk
        number (confidence interval 95%)
    8.96 (8.23 to 9.72)
    6.85 (6.22 to 7.51)
    Notes
    [1] - Randomised set (RS) included all randomised participants, whether treated or not.
    [2] - Randomised set (RS) included all randomised participants, whether treated or not.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD−EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment. Comparison vs. Placebo
    Comparison groups
    Placebo v Empagliflozin 10 mg
    Number of subjects included in analysis
    6609
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 99.83%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.89
    Notes
    [3] - Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin. Two-sided significance level of <0.0017 required at interim analysis.

    Secondary: Key secondary endpoint: Interventional part - Time to first hospitalization for heart failure (‘as adjudicated’) or cardiovascular death (‘as adjudicated’)

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    End point title
    		 Key secondary endpoint: Interventional part - Time to first hospitalization for heart failure (‘as adjudicated’) or cardiovascular death (‘as adjudicated’)
    End point description
    Incidence rate of first hospitalization for heart failure or cardiovascular death is reported in the Outcome Measure Data Table because metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced. Incidence rate= (Number of patients who experienced the event of first hospitalization for heart failure or cardiovascular death) *100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk [days] over all patients in a treatment group / 365.25.
    End point type
    Secondary
    End point timeframe
    Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
    End point values
    		 Placebo Empagliflozin 10 mg
    Number of subjects analysed
    3305 [4]
    3304 [5]
    Units: patients with events/100 pt-yrs at risk
        number (confidence interval 95%)
    2.39 (2.03 to 2.78)
    2.04 (1.70 to 2.40)
    Notes
    [4] - Randomised set (RS) included all randomised participants, whether treated or not.
    [5] - Randomised set (RS) included all randomised participants, whether treated or not.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Hazard ratio (HR) of the time to first hospitalization for heart failure or cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD−EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment. Comparison vs. Placebo
    Comparison groups
    Placebo v Empagliflozin 10 mg
    Number of subjects included in analysis
    6609
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.1363
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.84
    Confidence interval
         level
    		 98.55%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.12
    Notes
    [6] - Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin. Two-sided significance level of <0.0145 required at interim analysis.

    Secondary: Key secondary endpoint: Interventional part - Time to occurrences of all-cause hospitalizations (first and recurrent combined)

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    End point title
    		 Key secondary endpoint: Interventional part - Time to occurrences of all-cause hospitalizations (first and recurrent combined)
    End point description
    Total number of all-cause hospitalizations (first and recurrent combined) is reported in the Outcome Measure Data Table. Conventional time-to-event (TTE) metrics such as the median not calculable for a recurrent TTE analysis.
    End point type
    Secondary
    End point timeframe
    Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
    End point values
    		 Placebo Empagliflozin 10 mg
    Number of subjects analysed
    3305 [7]
    3304 [8]
    Units: events (first and recurrent)
    1895
    1612
    Notes
    [7] - Randomised set (RS) included all randomised participants, whether treated or not.
    [8] - Randomised set (RS) included all randomised participants, whether treated or not.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Hazard ratio (HR) of the time to occurrences of all-cause hospitalizations (first and recurrent combined). HR based on an analysis of recurrent events accounting for terminal events using a joint frailty model with terms for age, log(local screening UACR), local screening Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD−EPI)), treatment, sex, screening diabetes status, region. Comparison vs. Placebo
    Comparison groups
    Placebo v Empagliflozin 10 mg
    Number of subjects included in analysis
    6609
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.0022
    Method
    		 Joint frailty model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    		 99.03%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 0.98
    Notes
    [9] - Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin. Two-sided significance level of <0.0097 required at interim analysis.

    Secondary: Key secondary endpoint: Interventional part - Time to death from any cause (‘as adjudicated’)

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    End point title
    		 Key secondary endpoint: Interventional part - Time to death from any cause (‘as adjudicated’)
    End point description
    Incidence rate of death from any cause is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced. Incidence rate of death from any cause = (Number of patients who experienced the event of death from any cause) * 100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk [days] over all patients in a treatment group / 365.25.
    End point type
    Secondary
    End point timeframe
    Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
    End point values
    		 Placebo Empagliflozin 10 mg
    Number of subjects analysed
    3305 [10]
    3304 [11]
    Units: patients with events/100 pt-yrs at risk
        number (confidence interval 95%)
    2.59 (2.21 to 3.00)
    2.29 (1.94 to 2.68)
    Notes
    [10] - Randomised set (RS) included all randomised participants, whether treated or not.
    [11] - Randomised set (RS) included all randomised participants, whether treated or not.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Hazard ratio (HR) of the time to death from any cause. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD−EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment. Comparison vs. Placebo
    Comparison groups
    Placebo v Empagliflozin 10 mg
    Number of subjects included in analysis
    6609
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 = 0.2122
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 97.1%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.11
    Notes
    [12] - Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin. Two-sided significance level of <0.0290 required at interim analysis.

    Secondary: Interventional part: Time to first occurrence of kidney disease progression

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    End point title
    		 Interventional part: Time to first occurrence of kidney disease progression
    End point description
    Incidence rate of first occurrence of kidney disease progression is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced. Incidence rate of first occurrence of kidney disease progression= (Number of patients who experienced the event of first occurrence of kidney disease progression) *100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk [days] over all patients in a treatment group / 365.25. Kidney disease progression was defined as: - end stage kidney disease (defined as the initiation of maintenance dialysis or receipt of a kidney transplant) OR - a sustained decline in estimated glomerular filtration rate (eGFR) to <10 mL/min/1.73m^2 OR - renal death OR - a sustained decline of ≥40% in eGFR from randomisation).
    End point type
    Secondary
    End point timeframe
    Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1136 days.
    End point values
    		 Placebo Empagliflozin 10 mg
    Number of subjects analysed
    3305 [13]
    3304 [14]
    Units: patients with events/100 pt-yrs at risk
        number (confidence interval 95%)
    8.09 (7.40 to 8.81)
    6.09 (5.50 to 6.72)
    Notes
    [13] - Randomised set (RS) included all randomised participants, whether treated or not.
    [14] - Randomised set (RS) included all randomised participants, whether treated or not.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD−EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment. Comparison vs. Placebo
    Comparison groups
    Placebo v Empagliflozin 10 mg
    Number of subjects included in analysis
    6609
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 < 0.0001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.81
    Notes
    [15] - Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.

    Secondary: Interventional part: Time to first occurrence cardiovascular death (‘as adjudicated’) or end stage kidney disease (ESKD)

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    End point title
    		 Interventional part: Time to first occurrence cardiovascular death (‘as adjudicated’) or end stage kidney disease (ESKD)
    End point description
    Incidence rate of first occurrence of cardiovascular death or end stage kidney disease (ESKD) is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced. Incidence rate of first occurrence cardiovascular death or end stage kidney disease (ESKD)= (Number of patients who experienced the event of first occurrence of cardiovascular death or end stage kidney disease (ESKD)) *100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk [days] over all patients in a treatment group / 365.25. ESKD was defined as the initiation of maintenance dialysis or receipt of a kidney transplant.
    End point type
    Secondary
    End point timeframe
    Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
    End point values
    		 Placebo Empagliflozin 10 mg
    Number of subjects analysed
    3305 [16]
    3304 [17]
    Units: patients with events/100 pt-yrs at risk
        number (confidence interval 95%)
    3.45 (3.01 to 3.92)
    2.55 (2.18 to 2.96)
    Notes
    [16] - Randomised set (RS) included all randomised participants, whether treated or not.
    [17] - Randomised set (RS) included all randomised participants, whether treated or not.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Hazard ratio (HR) of the time to first occurrence cardiovascular death or end stage kidney disease (ESKD). HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD−EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment. Comparison vs. Placebo
    Comparison groups
    Placebo v Empagliflozin 10 mg
    Number of subjects included in analysis
    6609
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [18]
    P-value
    		 = 0.0017
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.89
    Notes
    [18] - Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.

    Secondary: Interventional part: Time to cardiovascular death (‘as adjudicated’)

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    End point title
    		 Interventional part: Time to cardiovascular death (‘as adjudicated’)
    End point description
    Incidence rate of first occurrence of kidney disease progression is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to insufficient events being experienced. Incidence rate of cardiovascular death is reported in the Outcome Measure Data Table. Metrics such as the median time-to-event (TTE) not estimable due to too few events being experienced. Incidence rate of cardiovascular death= (Number of patients who experienced the event of cardiovascular death) *100/(patient years at risk (pt-yrs at risk)). pt-yrs at risk= sum of time at risk [days] over all patients in a treatment group / 365.25.
    End point type
    Secondary
    End point timeframe
    Follow-up period: From the day of randomisation to the day of the final follow-up visit, up to 1140 days.
    End point values
    		 Placebo Empagliflozin 10 mg
    Number of subjects analysed
    3305 [19]
    3304 [20]
    Units: patients with events/100 pt-yrs at risk
        number (confidence interval 95%)
    1.08 (0.84 to 1.35)
    0.91 (0.69 to 1.15)
    Notes
    [19] - Randomised set (RS) included all randomised participants, whether treated or not.
    [20] - Randomised set (RS) included all randomised participants, whether treated or not.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Hazard ratio (HR) of the time to cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD−EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment. Comparison vs. Placebo
    Comparison groups
    Placebo v Empagliflozin 10 mg
    Number of subjects included in analysis
    6609
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 = 0.2932
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.17
    Notes
    [21] - Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    [All-cause Mortality]: From randomisation until end of study, up to 1171 days. [Serious adverse events (AE) and other AE]: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days.
    Adverse event reporting additional description
    Treated Set (TS): This patient set included all patients who were dispensed randomised study medication. Only protocol pre-specified non-serious Adverse Events (AEs) were collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Empa 10mg
    Reporting group description
    		 Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.

    Serious adverse events
    		 Empa 10mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1089 / 3304 (32.96%)
    1167 / 3305 (35.31%)
         number of deaths (all causes)
    159
    182
         number of deaths resulting from adverse events
    130
    137
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenosquamous cell lung cancer
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenosquamous cell lung cancer stage IV
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaplastic astrocytoma
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Angiosarcoma
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Basal cell carcinoma
         subjects affected / exposed
    11 / 3304 (0.33%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign gastrointestinal neoplasm
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of skin
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Biliary neoplasm
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder adenocarcinoma stage III
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    6 / 3304 (0.18%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer female
         subjects affected / exposed
    1 / 3304 (0.03%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer in situ
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer male
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoid tumour of the prostate
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoma in situ of penis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoma in situ of skin
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell sarcoma of the kidney
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    2 / 3304 (0.06%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colon cancer stage 0
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer stage I
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer stage III
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer stage IV
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colorectal cancer
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer stage III
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear neoplasm malignant
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enchondromatosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extranodal marginal zone B-cell lymphoma (MALT type)
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicle centre lymphoma, follicular grade I, II, III
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gallbladder cancer metastatic
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer recurrent
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal cancer
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    2 / 3304 (0.06%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Hepatic cancer stage II
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypopharyngeal cancer
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    1 / 3304 (0.03%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Lung neoplasm malignant
         subjects affected / exposed
    3 / 3304 (0.09%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of renal pelvis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melanoma recurrent
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to spinal cord
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic bronchial carcinoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic renal cell carcinoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoclonal gammopathy
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myeloproliferative neoplasm
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer stage I
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer stage II
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Osteosarcoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ovarian neoplasm
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 3304 (0.06%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pancreatic carcinoma stage II
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peritoneal sarcoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma recurrent
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural neoplasm
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer
         subjects affected / exposed
    8 / 3304 (0.24%)
    10 / 3305 (0.30%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer recurrent
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer stage II
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    6 / 3304 (0.18%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    2 / 3304 (0.06%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Soft tissue neoplasm
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord neoplasm
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    3 / 3304 (0.09%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thymoma malignant
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thyroid adenoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transformation to acute myeloid leukaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Arterial stenosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic occlusion
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic dissection rupture
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic aneurysm
         subjects affected / exposed
    3 / 3304 (0.09%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    5 / 3304 (0.15%)
    8 / 3305 (0.24%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    3 / 3304 (0.09%)
    8 / 3305 (0.24%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    3 / 3304 (0.09%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    4 / 3304 (0.12%)
    9 / 3305 (0.27%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Circulatory collapse
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CT hypotension complex
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrosis ischaemic
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    4 / 3304 (0.12%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vein rupture
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    4 / 3304 (0.12%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Aneurysm repair
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioplasty
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm repair
         subjects affected / exposed
    1 / 3304 (0.03%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve repair
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve replacement
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicectomy
         subjects affected / exposed
    2 / 3304 (0.06%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial repair
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stent insertion
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula operation
         subjects affected / exposed
    4 / 3304 (0.12%)
    8 / 3305 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous shunt operation
         subjects affected / exposed
    8 / 3304 (0.24%)
    12 / 3305 (0.36%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder catheter removal
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder catheterisation
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder lesion excision
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder operation
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder polypectomy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone debridement
         subjects affected / exposed
    3 / 3304 (0.09%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone operation
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CSF shunt operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ablation
         subjects affected / exposed
    5 / 3304 (0.15%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker battery replacement
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker insertion
         subjects affected / exposed
    10 / 3304 (0.30%)
    12 / 3305 (0.36%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker removal
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
         subjects affected / exposed
    4 / 3304 (0.12%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac resynchronisation therapy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardioversion
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stent insertion
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid endarterectomy
         subjects affected / exposed
    3 / 3304 (0.09%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract operation
         subjects affected / exposed
    12 / 3304 (0.36%)
    27 / 3305 (0.82%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemotherapy
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest wall operation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    5 / 3304 (0.15%)
    7 / 3305 (0.21%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colectomy
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colostomy
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colostomy closure
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary angioplasty
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary arterial stent insertion
         subjects affected / exposed
    5 / 3304 (0.15%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery bypass
         subjects affected / exposed
    1 / 3304 (0.03%)
    8 / 3305 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst removal
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dialysis device insertion
         subjects affected / exposed
    11 / 3304 (0.33%)
    19 / 3305 (0.57%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear operation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elbow operation
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endarterectomy
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial ablation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    External fixation of fracture
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye operation
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid operation
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot amputation
         subjects affected / exposed
    5 / 3304 (0.15%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture treatment
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder operation
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric operation
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric stapling
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal surgery
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma surgery
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoid operation
         subjects affected / exposed
    4 / 3304 (0.12%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve replacement
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatectomy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic embolisation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia repair
         subjects affected / exposed
    4 / 3304 (0.12%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    3 / 3304 (0.09%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip surgery
         subjects affected / exposed
    6 / 3304 (0.18%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospitalisation
         subjects affected / exposed
    10 / 3304 (0.30%)
    13 / 3305 (0.39%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hysterectomy
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator insertion
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator replacement
         subjects affected / exposed
    3 / 3304 (0.09%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc operation
         subjects affected / exposed
    4 / 3304 (0.12%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal polypectomy
         subjects affected / exposed
    5 / 3304 (0.15%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-cerebral aneurysm operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint arthroplasty
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint surgery
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    9 / 3304 (0.27%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee operation
         subjects affected / exposed
    6 / 3304 (0.18%)
    10 / 3305 (0.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine operation
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leg amputation
         subjects affected / exposed
    7 / 3304 (0.21%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Liver operation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Low density lipoprotein apheresis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastectomy
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Middle ear operation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve repair
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal operation
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrectomy
         subjects affected / exposed
    3 / 3304 (0.09%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal operation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oophorectomy
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open reduction of fracture
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral surgery
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Packed red blood cell transfusion
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain management
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic operation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroidectomy
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic floor repair
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Percutaneous coronary intervention
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery angioplasty
         subjects affected / exposed
    3 / 3304 (0.09%)
    7 / 3305 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery bypass
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stent insertion
         subjects affected / exposed
    5 / 3304 (0.15%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral endarterectomy
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral revascularisation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic operation
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radical prostatectomy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiotherapy
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse repair
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of foreign body from joint
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of internal fixation
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal stone removal
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal laser coagulation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin graft
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fusion surgery
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal laminectomy
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal operation
         subjects affected / exposed
    2 / 3304 (0.06%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stem cell transplant
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma evacuation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral prostatectomy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral bladder resection
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transmyocardial revascularisation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheostomy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth extraction
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteral stent removal
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroidectomy
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombectomy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve repair
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteral stent insertion
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toe amputation
         subjects affected / exposed
    16 / 3304 (0.48%)
    11 / 3305 (0.33%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine operation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine dilation and curettage
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric operation
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric calculus removal
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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
    Abortion
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    10 / 3304 (0.30%)
    10 / 3305 (0.30%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 10
    0 / 10
    Autoresuscitation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    7 / 3304 (0.21%)
    12 / 3305 (0.36%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    12 / 3304 (0.36%)
    17 / 3305 (0.51%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 17
         deaths causally related to treatment / all
    0 / 12
    0 / 17
    Pain
         subjects affected / exposed
    4 / 3304 (0.12%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 3304 (0.03%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    4 / 3304 (0.12%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Graft versus host disease in gastrointestinal tract
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergy to vaccine
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Social problem
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysfunctional uterine bleeding
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian failure
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    2 / 3304 (0.06%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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
    3 / 3304 (0.09%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic respiratory failure
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Combined pulmonary fibrosis and emphysema
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    6 / 3304 (0.18%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilic pneumonia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 3304 (0.03%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    6 / 3304 (0.18%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 3304 (0.03%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonitis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    4 / 3304 (0.12%)
    8 / 3305 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary hypertension
         subjects affected / exposed
    2 / 3304 (0.06%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary oedema
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord disorder
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    2 / 3304 (0.06%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic behaviour
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    3 / 3304 (0.09%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder necrosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    6 / 3304 (0.18%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    9 / 3304 (0.27%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    4 / 3304 (0.12%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis cholestatic
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    1 / 3304 (0.03%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    5 / 3304 (0.15%)
    7 / 3305 (0.21%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Non-alcoholic fatty liver
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiogram
         subjects affected / exposed
    4 / 3304 (0.12%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiogram peripheral
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriogram carotid
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriogram coronary
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy intestine
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy kidney
         subjects affected / exposed
    6 / 3304 (0.18%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy liver
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy prostate
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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
    43 / 3304 (1.30%)
    56 / 3305 (1.69%)
         occurrences causally related to treatment / all
    2 / 47
    1 / 61
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    1 / 3304 (0.03%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    76 / 3304 (2.30%)
    87 / 3305 (2.63%)
         occurrences causally related to treatment / all
    0 / 81
    0 / 89
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure decreased
         subjects affected / exposed
    4 / 3304 (0.12%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood sodium decreased
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchoscopy
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    8 / 3304 (0.24%)
    11 / 3305 (0.33%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonoscopy
         subjects affected / exposed
    1 / 3304 (0.03%)
    9 / 3305 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Computerised tomogram
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus test positive
         subjects affected / exposed
    6 / 3304 (0.18%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystoscopy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endoscopy gastrointestinal
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endoscopy upper gastrointestinal tract
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigation
         subjects affected / exposed
    4 / 3304 (0.12%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngoscopy
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nuclear magnetic resonance imaging abdominal
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep study
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ultrasound kidney
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ultrasound liver
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ultrasound scan
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteroscopy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    6 / 3304 (0.18%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    2 / 3304 (0.06%)
    9 / 3305 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    5 / 3304 (0.15%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fracture
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured ischium
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve replacement complication
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    3 / 3304 (0.09%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    17 / 3304 (0.51%)
    19 / 3305 (0.57%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 3304 (0.03%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crush injury
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    5 / 3304 (0.15%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    3 / 3304 (0.09%)
    7 / 3305 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Humerus fracture
         subjects affected / exposed
    5 / 3304 (0.15%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inadequate haemodialysis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle injury
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal injury
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery restenosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post angioplasty restenosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    4 / 3304 (0.12%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Skin injury
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin wound
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury lumbar
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic injury
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    2 / 3304 (0.06%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subdural haemorrhage
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Upper limb fracture
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaccination complication
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular injury
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Myocardial bridging
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart block congenital
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital vesicoureteric reflux
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenomatous polyposis coli
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis-pseudoglioma syndrome
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalassaemia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    6 / 3304 (0.18%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    8 / 3304 (0.24%)
    19 / 3305 (0.57%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    11 / 3304 (0.33%)
    9 / 3305 (0.27%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Aortic valve incompetence
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    4 / 3304 (0.12%)
    7 / 3305 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arrhythmia
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    18 / 3304 (0.54%)
    32 / 3305 (0.97%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bradyarrhythmia
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    5 / 3304 (0.15%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    4 / 3304 (0.12%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    41 / 3304 (1.24%)
    44 / 3305 (1.33%)
         occurrences causally related to treatment / all
    0 / 53
    0 / 59
         deaths causally related to treatment / all
    0 / 9
    0 / 10
    Sinus arrest
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 3304 (0.03%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    39 / 3304 (1.18%)
    31 / 3305 (0.94%)
         occurrences causally related to treatment / all
    0 / 41
    0 / 34
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Mitral valve incompetence
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertensive heart disease
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    33 / 3304 (1.00%)
    45 / 3305 (1.36%)
         occurrences causally related to treatment / all
    0 / 41
    0 / 63
         deaths causally related to treatment / all
    0 / 10
    0 / 7
    Hypertensive cardiomyopathy
         subjects affected / exposed
    5 / 3304 (0.15%)
    10 / 3305 (0.30%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary vein stenosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac fibrillation
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac sarcoidosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    7 / 3304 (0.21%)
    14 / 3305 (0.42%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery stenosis
         subjects affected / exposed
    3 / 3304 (0.09%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachyarrhythmia
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         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
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    3 / 3304 (0.09%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 3304 (0.03%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Basal ganglia infarction
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basilar artery thrombosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain stem infarction
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery aneurysm
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    2 / 3304 (0.06%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cranial nerve paralysis
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic neuropathy
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 3304 (0.09%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness postural
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epilepsy
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    10 / 3304 (0.30%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Headache
         subjects affected / exposed
    6 / 3304 (0.18%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic encephalopathy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    30 / 3304 (0.91%)
    34 / 3305 (1.03%)
         occurrences causally related to treatment / all
    1 / 32
    1 / 39
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Lacunar infarction
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 3304 (0.03%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microvascular cranial nerve palsy
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Movement disorder
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post stroke seizure
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 3304 (0.00%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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
    4 / 3304 (0.12%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord herniation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    16 / 3304 (0.48%)
    8 / 3305 (0.24%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    12 / 3304 (0.36%)
    14 / 3305 (0.42%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual field defect
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 3304 (0.06%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aplasia pure red cell
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia of chronic disease
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    2 / 3304 (0.06%)
    10 / 3305 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic anaemia
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness unilateral
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    4 / 3304 (0.12%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    3 / 3304 (0.09%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic eye disease
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacrimal disorder
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcerative keratitis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lens dislocation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy proliferative
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Chronic gastrointestinal bleeding
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal incarcerated hernia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal mass
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    7 / 3304 (0.21%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal obstruction
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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 / 3304 (0.03%)
    0 / 3305 (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
    3 / 3304 (0.09%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 3304 (0.06%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ischaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Gastrointestinal haemorrhage
         subjects affected / exposed
    6 / 3304 (0.18%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal fistula
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 3304 (0.03%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Inguinal hernia
         subjects affected / exposed
    3 / 3304 (0.09%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 3304 (0.03%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery stenosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    5 / 3304 (0.15%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jejunal perforation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal polyp
         subjects affected / exposed
    4 / 3304 (0.12%)
    7 / 3305 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 3304 (0.03%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 3304 (0.06%)
    10 / 3305 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Varices oesophageal
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 3304 (0.12%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal fibrosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathic ulcer
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ulcer
         subjects affected / exposed
    3 / 3304 (0.09%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Henoch-Schonlein purpura
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash vesicular
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin haemorrhage
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin irritation
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    93 / 3304 (2.81%)
    117 / 3305 (3.54%)
         occurrences causally related to treatment / all
    7 / 98
    2 / 128
         deaths causally related to treatment / all
    0 / 12
    0 / 14
    Calculus urethral
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic end stage renal disease
         subjects affected / exposed
    5 / 3304 (0.15%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    4 / 3304 (0.12%)
    9 / 3305 (0.27%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    35 / 3304 (1.06%)
    27 / 3305 (0.82%)
         occurrences causally related to treatment / all
    0 / 37
    1 / 30
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis membranoproliferative
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis membranous
         subjects affected / exposed
    3 / 3304 (0.09%)
    7 / 3305 (0.21%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    3 / 3304 (0.09%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    4 / 3304 (0.12%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IgA nephropathy
         subjects affected / exposed
    4 / 3304 (0.12%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraneoplastic nephrotic syndrome
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal disorder
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    3 / 3304 (0.09%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroiditis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 3304 (0.06%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         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 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    3 / 3304 (0.09%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 3304 (0.03%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint destruction
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         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 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle atrophy
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    4 / 3304 (0.12%)
    10 / 3305 (0.30%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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
    4 / 3304 (0.12%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    3 / 3304 (0.09%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    3 / 3304 (0.09%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis infective
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Appendicitis
         subjects affected / exposed
    5 / 3304 (0.15%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess soft tissue
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Abdominal abscess
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bacterial infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone abscess
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 3304 (0.06%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve abscess
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    9 / 3304 (0.27%)
    12 / 3305 (0.36%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cellulitis gangrenous
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    98 / 3304 (2.97%)
    107 / 3305 (3.24%)
         occurrences causally related to treatment / all
    0 / 99
    0 / 111
         deaths causally related to treatment / all
    0 / 17
    0 / 20
    Cystitis
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    17 / 3304 (0.51%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    4 / 3304 (0.12%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endocarditis
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Empyema
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    7 / 3304 (0.21%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    8 / 3304 (0.24%)
    10 / 3305 (0.30%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal bacterial infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital infection fungal
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia gangrenous
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 3304 (0.03%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis bacterial
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising soft tissue infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nail infection
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle abscess
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningoencephalitis bacterial
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphangitis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 3304 (0.12%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral infection
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    7 / 3304 (0.21%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    3 / 3304 (0.09%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis bacterial
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    39 / 3304 (1.18%)
    42 / 3305 (1.27%)
         occurrences causally related to treatment / all
    0 / 39
    0 / 47
         deaths causally related to treatment / all
    0 / 6
    0 / 9
    Pleural infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    0 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic abscess
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Otitis externa
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 3304 (0.06%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         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
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia streptococcal
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoas abscess
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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 / 3304 (0.00%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelocystitis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 3304 (0.09%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pyelonephritis acute
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Severe invasive streptococcal infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 3304 (0.12%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    8 / 3304 (0.24%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Retroperitoneal abscess
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Spinal cord abscess
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal infection
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic bacterial infection
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis septic
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    3 / 3304 (0.09%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urosepsis
         subjects affected / exposed
    6 / 3304 (0.18%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    1 / 7
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    7 / 3304 (0.21%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    27 / 3304 (0.82%)
    31 / 3305 (0.94%)
         occurrences causally related to treatment / all
    2 / 29
    0 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    2 / 3304 (0.06%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 3304 (0.06%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound abscess
         subjects affected / exposed
    2 / 3304 (0.06%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 3304 (0.03%)
    2 / 3305 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral pericarditis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral pharyngitis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    22 / 3304 (0.67%)
    20 / 3305 (0.61%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    19 / 3304 (0.58%)
    23 / 3305 (0.70%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    5 / 3304 (0.15%)
    6 / 3305 (0.18%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    5 / 3304 (0.15%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    4 / 3304 (0.12%)
    9 / 3305 (0.27%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    0 / 3304 (0.00%)
    3 / 3305 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    5 / 3304 (0.15%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    8 / 3304 (0.24%)
    14 / 3305 (0.42%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 3304 (0.00%)
    4 / 3305 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    14 / 3304 (0.42%)
    14 / 3305 (0.42%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypocalcaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    12 / 3304 (0.36%)
    11 / 3305 (0.33%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    3 / 3304 (0.09%)
    5 / 3305 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    4 / 3304 (0.12%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insulin-requiring type 2 diabetes mellitus
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketosis
         subjects affected / exposed
    1 / 3304 (0.03%)
    0 / 3305 (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 / 3304 (0.03%)
    1 / 3305 (0.03%)
         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
    6 / 3304 (0.18%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    8 / 3304 (0.24%)
    9 / 3305 (0.27%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uraemic acidosis
         subjects affected / exposed
    0 / 3304 (0.00%)
    1 / 3305 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Empa 10mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    228 / 3304 (6.90%)
    262 / 3305 (7.93%)
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    228 / 3304 (6.90%)
    262 / 3305 (7.93%)
         occurrences all number
    314
    381

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jan 2020
    The recruitment target was increased to at least 6000 participants. Further exclusion of participation from people with type 1 diabetes was specified after introduction of a cap. Clarification was provided regarding the subdivisions of cardiovascular (CV) death. Tertiary subgroup analyses were restricted solely to the primary outcome and subgroups of key interest were specified.

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

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

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