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    Clinical Trial Results:
    A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

    Summary
    EudraCT number
    		 2017-000996-98
    Trial protocol
    		 GB   LV   SE   PT   FI   BE   LT   DK   EE   DE   AT   CZ   NO   HU   FR   NL   ES   SK   BG   GR   HR   IT   RO  
    Global end of trial date
    17 Nov 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Feb 2025
    First version publication date
    20 Oct 2024
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor updates have been made to align the results posting with the study's clinicaltrials.gov results record.

    Trial information

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    Trial identification
    Sponsor protocol code
    CSL112_3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03473223
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Behring LLC
    Sponsor organisation address
    1020 First Avenue, King of Prussia, PA, United States, 19406-0901
    Public contact
    Trial Registration Coordinator, CSL Behring LLC, +1 610-878-4000, clinicaltrials@cslbehring.com
    Scientific contact
    Trial Registration Coordinator, CSL Behring LLC, +1 610-878-4000, clinicaltrials@cslbehring.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of CSL112 in reducing the risk of Major adverse cardiovascular event (MACE) (cardiovascular [CV] death, myocardial infarction [MI], or stroke) from the time of randomisation through 90 days in subjects with acute coronary syndrome (ACS) (diagnosed with ST-segment elevation myocardial infarction [STEMI] or Non-ST-segment elevation myocardial infarction [NSTEMI]).
    Protection of trial subjects
    This study was carried out in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, the ethical principles that have their origin in the Declaration of Helsinki, all applicable national and local regulations, and standard operating procedures for clinical research and development at CSL Behring (CSL). The study protocol and all amendments were approved by the Independent Ethics Committee (IEC) of the participating center. Before any protocol-specific procedures were carried out, participants were informed, in an understandable form, about the nature, scope, and possible consequences of the study. Participant informed consent was obtained and documented according to the provisions of ICH GCP and applicable regulatory requirements. Written informed consent was provided by each participant before any protocol-specific procedures were carried out.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Mar 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 869
    Country: Number of subjects enrolled
    Chile: 53
    Country: Number of subjects enrolled
    Colombia: 137
    Country: Number of subjects enrolled
    Malaysia: 278
    Country: Number of subjects enrolled
    New Zealand: 101
    Country: Number of subjects enrolled
    Peru: 14
    Country: Number of subjects enrolled
    Singapore: 39
    Country: Number of subjects enrolled
    United Kingdom: 99
    Country: Number of subjects enrolled
    United States: 1845
    Country: Number of subjects enrolled
    Austria: 122
    Country: Number of subjects enrolled
    Belgium: 178
    Country: Number of subjects enrolled
    Bulgaria: 553
    Country: Number of subjects enrolled
    Croatia: 40
    Country: Number of subjects enrolled
    Czechia: 106
    Country: Number of subjects enrolled
    Denmark: 177
    Country: Number of subjects enrolled
    Estonia: 149
    Country: Number of subjects enrolled
    Finland: 24
    Country: Number of subjects enrolled
    France: 193
    Country: Number of subjects enrolled
    Germany: 337
    Country: Number of subjects enrolled
    Greece: 152
    Country: Number of subjects enrolled
    Hungary: 904
    Country: Number of subjects enrolled
    Italy: 181
    Country: Number of subjects enrolled
    Latvia: 69
    Country: Number of subjects enrolled
    Lithuania: 210
    Country: Number of subjects enrolled
    Netherlands: 1486
    Country: Number of subjects enrolled
    Norway: 36
    Country: Number of subjects enrolled
    Poland: 1006
    Country: Number of subjects enrolled
    Portugal: 151
    Country: Number of subjects enrolled
    Romania: 764
    Country: Number of subjects enrolled
    Slovakia: 16
    Country: Number of subjects enrolled
    Spain: 167
    Country: Number of subjects enrolled
    Sweden: 26
    Country: Number of subjects enrolled
    Türkiye: 450
    Country: Number of subjects enrolled
    Switzerland: 172
    Country: Number of subjects enrolled
    Ukraine: 734
    Country: Number of subjects enrolled
    Hong Kong: 35
    Country: Number of subjects enrolled
    Taiwan: 194
    Country: Number of subjects enrolled
    Australia: 329
    Country: Number of subjects enrolled
    Brazil: 1553
    Country: Number of subjects enrolled
    Canada: 508
    Country: Number of subjects enrolled
    Georgia: 178
    Country: Number of subjects enrolled
    Israel: 1015
    Country: Number of subjects enrolled
    Japan: 322
    Country: Number of subjects enrolled
    Korea, Republic of: 194
    Country: Number of subjects enrolled
    Mexico: 283
    Country: Number of subjects enrolled
    Russian Federation: 878
    Country: Number of subjects enrolled
    Serbia: 511
    Country: Number of subjects enrolled
    South Africa: 100
    Country: Number of subjects enrolled
    Thailand: 281
    Worldwide total number of subjects
    18219
    EEA total number of subjects
    7047
    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)
    7460
    From 65 to 84 years
    10435
    85 years and over
    324

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 897 centers across 5 regions (North America, Latin America, Western Europe, Central and Eastern Europe, and Asia Pacific).

    Pre-assignment
    Screening details
    		 A total of 18,848 participants were screened, with 622 identified as screen failures. Of the screened participants, 18,226 were randomized in 1:1 ratio to receive study interventions (CSL112 or Placebo), and 7 of these randomized participants were excluded from analysis per sponsor decision. Intent-to-treat population used for disposition.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CSL112
    Arm description
    		 Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apolipoprotein A-I [human] (apoA-I)
    Investigational medicinal product code
    CSL112
    Other name
    CSL112
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Apolipoprotein A-I [human] (apoA-I) purified from human plasma for intravenous administration.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25% albumin solution diluted to 4.4% was administered IV at the same volume and duration as that of CSL112.

    Number of subjects in period 1
    		CSL112 Placebo
    Started
    9112
    9107
    Safety Analysis Set (SAS)
    9010
    9027
    Completed
    9002
    9020
    Not completed
    110
    87
         Indirect contact
    32
    29
         Other-unspecified
    30
    15
         Withdrawal by Subject
    47
    42
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CSL112
    Reporting group description
    		 Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.

    Reporting group values
    		 CSL112 Placebo Total
    Number of subjects
    		 9112 9107 18219
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.6 ( 10.09 ) 65.4 ( 10.21 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2326 2386 4712
        Male
    		 6786 6721 13507
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1566 1596 3162
        Not Hispanic or Latino
    		 7410 7383 14793
        Unknown or Not Reported
    		 136 128 264
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 51 36 87
        Asian
    		 743 781 1524
        Native Hawaiian or Other Pacific Islander
    		 8 10 18
        Black or African American
    		 181 181 362
        White
    		 7769 7698 15467
        Multiracial or other
    		 314 356 670
        Unknown or Not Reported
    		 46 45 91

    End points

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    End points reporting groups
    Reporting group title
    CSL112
    Reporting group description
    		 Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.

    Primary: Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)

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    End point title
    		 Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)
    End point description
    MACE (Major adverse cardiovascular event[s])(CV [cardiovascular] death, MI [Myocardial Infarction], or stroke). Analysis was performed on the intent-to-treat (ITT) analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
    End point type
    Primary
    End point timeframe
    From the time of randomization through 90 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9112
    9107
    Units: participants
    439
    472
    Statistical analysis title
    		 CSL112 versus Placebo
    Comparison groups
    CSL112 v Placebo
    Number of subjects included in analysis
    18219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.121 [1]
    Method
    		 Cox proportional hazards regression
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.925
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8126
         upper limit
    		 1.0538
    Notes
    [1] - 1-sided p-value.

    Secondary: Total Number of Hospitalizations for Coronary, Cerebral, or Peripheral Ischemia

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    End point title
    		 Total Number of Hospitalizations for Coronary, Cerebral, or Peripheral Ischemia
    End point description
    The total number of hospitalizations and individual hospitalizations due to coronary, cerebral, and peripheral ischemia were reported. Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From the time of randomization through 90 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9112
    9107
    Units: hospitalizations
    number (not applicable)
        Total hospitalizations
    433
    442
        Coronary ischemia
    367
    376
        Cerebral ischemia
    39
    36
        Peripheral ischemia
    27
    30
    Statistical analysis title
    		 CSL112 versus Placebo
    Comparison groups
    CSL112 v Placebo
    Number of subjects included in analysis
    18219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.341 [2]
    Method
    		 Negative binomial regression model
    Parameter type
    		 Rate ratio
    Point estimate
    0.971
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8442
         upper limit
    		 1.1171
    Notes
    [2] - 1-sided p-value.

    Secondary: Number of Participants With First Occurrence of CV Death, MI, or Stroke

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    End point title
    		 Number of Participants With First Occurrence of CV Death, MI, or Stroke
    End point description
    Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From the time of randomization through 180 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9112
    9107
    Units: participants
    622
    683
    Statistical analysis title
    		 CSL112 versus Placebo
    Comparison groups
    CSL112 v Placebo
    Number of subjects included in analysis
    18219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.038
    Method
    		 Cox proportional hazards regression
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.907
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8132
         upper limit
    		 1.0106
    Notes
    [3] - 1-sided p-value.

    Secondary: Number of Participants With First Occurrence of CV Death, MI, or Stroke

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    End point title
    		 Number of Participants With First Occurrence of CV Death, MI, or Stroke
    End point description
    Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From the time of randomization through 365 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9112
    9107
    Units: participants
    885
    944
    Statistical analysis title
    		 CSL112 versus Placebo
    Comparison groups
    CSL112 v Placebo
    Number of subjects included in analysis
    18219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.069 [4]
    Method
    		 Cox proportional hazards regression
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.933
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8511
         upper limit
    		 1.0224
    Notes
    [4] - 1-sided p-value.

    Secondary: Number of Participants With Occurrence of CV Death

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    End point title
    		 Number of Participants With Occurrence of CV Death
    End point description
    Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From the time of randomization through 90 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9112
    9107
    Units: participants
    107
    128
    Statistical analysis title
    		 CSL112 versus Placebo
    Comparison groups
    CSL112 v Placebo
    Number of subjects included in analysis
    18219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.074 [5]
    Method
    		 Cox proportional hazards regression
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.827
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6399
         upper limit
    		 1.0695
    Notes
    [5] - 1-sided p-value.

    Secondary: Number of Participants With First Occurrence of MI

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    End point title
    		 Number of Participants With First Occurrence of MI
    End point description
    Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From the time of randomization through 90 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9112
    9107
    Units: participants
    312
    342
    Statistical analysis title
    		 CSL112 versus Placebo
    Comparison groups
    CSL112 v Placebo
    Number of subjects included in analysis
    18219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.113 [6]
    Method
    		 Cox proportional hazards regression
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.909
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7801
         upper limit
    		 1.0603
    Notes
    [6] - 1-sided p-value.

    Secondary: Number of Participants With First Occurrence of Stroke

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    End point title
    		 Number of Participants With First Occurrence of Stroke
    End point description
    Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From the time of randomization through 90 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9112
    9107
    Units: participants
    57
    49
    Statistical analysis title
    		 CSL112 versus Placebo
    Comparison groups
    CSL112 v Placebo
    Number of subjects included in analysis
    18219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.767 [7]
    Method
    		 Cox proportional hazards regression
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.153
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7867
         upper limit
    		 1.6886
    Notes
    [7] - 1-sided p-value.

    Secondary: Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke

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    End point title
    		 Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke
    End point description
    Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From the time of randomization through 90, 180 and 365 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9112
    9107
    Units: participants
        Through Day 90
    272
    308
        Through Day 180
    400
    444
        Through Day 365
    594
    639
    No statistical analyses for this end point

    Secondary: Number of Participants With Occurrence of All-cause Death

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    End point title
    		 Number of Participants With Occurrence of All-cause Death
    End point description
    Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.
    End point type
    Secondary
    End point timeframe
    From the time of randomization through 365 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9112
    9107
    Units: participants
    341
    345
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events

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    End point title
    		 Number of Participants With Adverse Events
    End point description
    An AE was defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Analysis was performed on the Safety analysis set (SAS). The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From the start of treatment through 90 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9010
    9027
    Units: participants
    3938
    3927
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Adverse Events

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    End point title
    		 Percentage of Participants With Adverse Events
    End point description
    An AE was defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From the start of treatment through 90 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9010
    9027
    Units: percentage of participants
        number (not applicable)
    43.7
    43.5
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-related Adverse Events

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    End point title
    		 Number of Participants With Treatment-related Adverse Events
    End point description
    Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product. Analysis was performed on the SAS.The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From the start of treatment through 379 days (Day 365 + 14 days of follow up)
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9010
    9027
    Units: participants
    350
    304
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Treatment-related Adverse Events

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    End point title
    		 Percentage of Participants With Treatment-related Adverse Events
    End point description
    Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product. As per the study statistical analysis plan (SAP), descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented. Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From the start of treatment through 379 days (Day 365 + 14 days of follow up)
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9010
    9027
    Units: percentage of participants
        number (not applicable)
    3.9
    3.4
    No statistical analyses for this end point

    Secondary: Number of Participants With Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs)
    End point description
    SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is a medically significant event. Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From the start of treatment through 379 days (Day 365 + 14 days of follow up)
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9010
    9027
    Units: participants
    1514
    1557
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SAEs

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    End point title
    		 Percentage of Participants With SAEs
    End point description
    SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is a medically significant event. As per the SAP, descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented. Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From the start of treatment through 379 days (Day 365 + 14 days of follow up)
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    9010
    9027
    Units: percentage of participants
        number (not applicable)
    16.8
    17.2
    No statistical analyses for this end point

    Secondary: Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments

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    End point title
    		 Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments
    End point description
    Clinical laboratory assessments included assessment of Hematology (hemoglobin, hematocrit, leukocytes and platelets) and Biochemistry (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin and estimated glomerular filtration rate [eGFR]). Number of participants with shift from Baseline value to worst post-treatment value (low, normal, or high) was reported. Worst criterion for parameters is as follows: hematocrit - low, hemoglobin - low, leukocytes - high, platelets - low,ALT - high, ALP - high, AST - high, bilirubin - high, direct bilirubin - high, indirect bilirubin - high, eGFR -severe impairment. SAS comprised all participants in ITT Analysis set who received any amount of investigational product, and were analyzed based on actual treatment received. Here, number of participants analysed (N) = all participants who were evaluated for this endpoint."n" = participants who were evaluated for this endpoint for the specified category.
    End point type
    Secondary
    End point timeframe
    Baseline and 29 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    8372
    8392
    Units: participants
        Hematocrit - High to Low (n=6848, 6810)
    0
    1
        Hematocrit - Normal to Low (n=6848, 6810)
    365
    393
        Hemoglobin - High to Low (n=7235,7185)
    0
    1
        Hemoglobin - Normal to Low (n=7235,7185)
    457
    447
        Leukocytes - Normal to High (n=7229,7184)
    267
    271
        Leukocytes - Low to High (n=7229,7184)
    2
    1
        Platelets - High to Low (n=7138,7064)
    0
    0
        Platelets - Normal to Low (n=7138,7064)
    92
    114
        ALT - Normal to High (n=7904,7949)
    658
    612
        ALT - Low to High (n=7904,7949)
    0
    0
        ALP - Normal to High (n=8341,8366)
    307
    350
        ALP - Low to High (n=8341,8366)
    1
    0
        AST - Normal to High (n=7910,7911)
    239
    253
        AST - Low to High (n=7910,7911)
    2
    0
        Bilirubin - Normal to High (n=8281,8284)
    73
    112
        Bilirubin - Low to High (n=8281,8284)
    0
    1
        Direct Bilirubin - Normal to High (n=7273,7317)
    18
    21
        Direct Bilirubin - Low to High (n=7273,7317)
    0
    0
        Indirect Bilirubin - Normal to High (n=7269,7309)
    31
    42
        Indirect Bilirubin - Low to High (n=7269,7309)
    0
    0
        eGFR - Normal to Severe (n=8372,8392)
    1
    2
        eGFR - Mild to Severe (n=8372,8392)
    15
    9
        eGFR - Moderate to Severe (n=8372,8392)
    91
    99
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments

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    End point title
    		 Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments
    End point description
    Clinical laboratory assessments included assessment of Hematology (hemoglobin, hematocrit, leukocytes and platelets) and Biochemistry (ALP, ALT, AST, bilirubin and eGFR). Percentage of participants with a shift from the Baseline value to the worst post-treatment value (low, normal, or high) was reported. The worst criterion for the parameters is as follows: hematocrit - low, hemoglobin - low, leukocytes - high, platelets - low, ALT - high, ALP - high, AST - high, bilirubin - high, direct bilirubin - high, indirect bilirubin - high, eGFR - severe impairment. Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the number of participants analyzed (N), included all participants who were evaluated for this endpoint and "n" included all participants who were evaluated for this endpoint for the specified category.
    End point type
    Secondary
    End point timeframe
    Baseline and 29 days
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    8372
    8392
    Units: percentage of participants
    number (not applicable)
        Hematocrit - High to Low (n=6848, 6810)
    0.0
    0.0
        Hematocrit - Normal to Low (n=6848, 6810)
    5.3
    5.8
        Hemoglobin - High to Low (n=7235,7185)
    0.0
    0.0
        Hemoglobin - Normal to Low (n=7235,7185)
    6.3
    6.2
        Leukocytes - Normal to High (n=7229,7184)
    3.7
    3.8
        Leukocytes - Low to High (n=7229,7184)
    0.0
    0.0
        Platelets - High to Low (n=7138,7064)
    0.0
    0.0
        Platelets - Normal to Low (n=7138,7064)
    1.3
    1.6
        ALT - Normal to High (n=7904,7949)
    8.3
    7.7
        ALT - Low to High (n=7904,7949)
    0.0
    0.0
        ALP - Normal to High (n=8341,8366)
    3.7
    4.2
        ALP - Low to High (n=8341,8366)
    0.0
    0.0
        AST - Normal to High (n=7910,7911)
    3.0
    3.2
        AST - Low to High (n=7910,7911)
    0.0
    0.0
        Bilirubin - Normal to High (n=8281,8284)
    0.9
    1.4
        Bilirubin - Low to High (n=8281,8284)
    0.0
    0.0
        Direct Bilirubin - Normal to High (n=7273,7317)
    0.2
    0.3
        Direct Bilirubin - Low to High (n=7273,7317)
    0.0
    0.0
        Indirect Bilirubin - Normal to High (n=7269,7309)
    0.4
    0.6
        Indirect Bilirubin - Low to High (n=7269,7309)
    0.0
    0.0
        eGFR - Normal to Severe (n=8372,8392)
    0.0
    0.0
        eGFR - Mild to Severe (n=8372,8392)
    0.2
    0.1
        eGFR - Moderate to Severe (n=8372,8392)
    1.1
    1.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameters

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    End point title
    		 Change From Baseline in Hematology Parameters
    End point description
    Hematology parameters included Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the number of participants analyzed (N), included all participants who were evaluated for this endpoint and "n" included all participants who were evaluated for this endpoint for the specified category.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 29
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    7073
    7021
    Units: 10^9 cells per litre
    arithmetic mean (standard deviation)
        Basophils (n=7061,7011)
    0.004 ( 0.0455 )
    0.005 ( 0.0462 )
        Eosinophils (n=7061,7011)
    0.045 ( 0.1766 )
    0.047 ( 0.1727 )
        Leukocytes (n=7073,7021)
    -1.024 ( 2.2905 )
    -0.969 ( 2.2683 )
        Lymphocytes (n=7061,7011)
    0.084 ( 0.5534 )
    0.080 ( 0.5409 )
        Monocytes (n=7061,7011)
    -0.089 ( 0.1886 )
    -0.087 ( 0.1961 )
        Neutrophils (n=7061,7011)
    -1.068 ( 2.0892 )
    -1.011 ( 2.0343 )
        Platelets (n=6985,6908)
    0.4 ( 56.09 )
    -1.4 ( 55.31 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Hematocrit

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    End point title
    		 Change From Baseline in Hematology Parameter: Hematocrit
    End point description
    Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the number of participants analyzed (N), included all participants who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 29
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    6698
    6651
    Units: litre per litre (L/L)
        arithmetic mean (standard deviation)
    -0.003 ( 0.0382 )
    -0.004 ( 0.0381 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Hemoglobin

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    End point title
    		 Change From Baseline in Hematology Parameter: Hemoglobin
    End point description
    Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the number of participants analyzed included all participants who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 29
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    7074
    7021
    Units: grams per litre (g/L)
        arithmetic mean (standard deviation)
    -1.1 ( 11.96 )
    -1.3 ( 12.08 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hepatic Parameters

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    End point title
    		 Change From Baseline in Hepatic Parameters
    End point description
    Hepatic parameters included ALT, ALP and AST. Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the number of participants analyzed (N), included all participants who were evaluated for this endpoint and "n" included all participants who were evaluated for this endpoint for the specified category.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 29
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    8079
    8072
    Units: units per litre
    arithmetic mean (standard deviation)
        ALT (n=7628,7630)
    -5.5 ( 25.52 )
    -6.5 ( 28.91 )
        ALP (n=8079,8072)
    3.2 ( 26.13 )
    4.5 ( 24.55 )
        AST (n=7616,7574)
    -21.2 ( 41.90 )
    -20.7 ( 61.63 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hepatic Parameter: Bilirubin

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    End point title
    		 Change From Baseline in Hepatic Parameter: Bilirubin
    End point description
    Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the number of participants analyzed (N), included all participants who were evaluated for this endpoint and "n" included all participants who were evaluated for this endpoint for the specified category.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 29
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    8005
    7983
    Units: micromol per litre (umol/L)
    arithmetic mean (standard deviation)
        Bilirubin (n=8005,7983)
    -2.6 ( 4.71 )
    -1.9 ( 5.05 )
        Direct Bilirubin (n=6961,6958)
    -0.4 ( 1.32 )
    -0.3 ( 1.75 )
        Indirect Bilirubin (n=6957,6950)
    -2.0 ( 3.85 )
    -1.4 ( 3.90 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Renal Parameter: Serum Creatinine

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    End point title
    		 Change From Baseline in Renal Parameter: Serum Creatinine
    End point description
    Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the number of participants analyzed (N), included all participants who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 29
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    8114
    8101
    Units: umol/L
        arithmetic mean (standard deviation)
    2.4 ( 24.39 )
    2.1 ( 21.23 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Renal Parameter: eGFR

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    End point title
    		 Change From Baseline in Renal Parameter: eGFR
    End point description
    Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the number of participants analyzed (N), included all participants who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 29
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    8112
    8098
    Units: millilitre per minute per 1.73 meter^2
        arithmetic mean (standard deviation)
    -1.3 ( 11.87 )
    -1.2 ( 12.15 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Renal Parameter: Blood Urea Nitrogen

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    End point title
    		 Change From Baseline in Renal Parameter: Blood Urea Nitrogen
    End point description
    Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the number of participants analyzed (N), included all participants who were evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 29
    End point values
    		 CSL112 Placebo
    Number of subjects analysed
    8114
    8105
    Units: millimoles per litre
        arithmetic mean (standard deviation)
    0.0 ( 2.76 )
    0.0 ( 2.67 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up)
    Adverse event reporting additional description
    All-cause mortality was monitored/assessed for the ITT population (N = 9112 for CSL112 and N= 9107 for Placebo), but Serious and Other AEs were only monitored/assessed for the SAS population. SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.

    Reporting group title
    CSL112
    Reporting group description
    		 Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events above the threshold of 5%.
    Serious adverse events
    		 Placebo CSL112
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1557 / 9027 (17.25%)
    1514 / 9010 (16.80%)
         number of deaths (all causes)
    355
    348
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    2 / 9027 (0.02%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    4 / 9027 (0.04%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Small cell lung cancer
         subjects affected / exposed
    1 / 9027 (0.01%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Gastric cancer
         subjects affected / exposed
    3 / 9027 (0.03%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Lung adenocarcinoma
         subjects affected / exposed
    4 / 9027 (0.04%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Prostate cancer
         subjects affected / exposed
    7 / 9027 (0.08%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    2 / 9027 (0.02%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    2 / 9027 (0.02%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    7 / 9027 (0.08%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer metastatic
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Benign pancreatic neoplasm
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder papilloma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoid tumour pulmonary
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    4 / 9027 (0.04%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder neoplasm
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer stage 0
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal adenocarcinoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Glioblastoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    4 / 9027 (0.04%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Lung squamous cell carcinoma stage IV
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant oligodendroglioma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone marrow
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to lung
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic uterine cancer
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma recurrent
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pituitary tumour benign
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cancer
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Small intestine adenocarcinoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral cancer metastatic
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval cancer
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma stage II
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Borderline mucinous tumour of ovary
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm benign
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer pain
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choroid melanoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ciliary body melanoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer stage I
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal papilloma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant urinary tract neoplasm
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic renal cell carcinoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ovarian cancer stage III
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic neuroendocrine tumour
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage II
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of renal pelvis and ureter metastatic
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma recurrent
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour necrosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    15 / 9027 (0.17%)
    17 / 9010 (0.19%)
         occurrences causally related to treatment / all
    2 / 15
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic aneurysm
         subjects affected / exposed
    4 / 9027 (0.04%)
    11 / 9010 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    14 / 9027 (0.16%)
    11 / 9010 (0.12%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    12 / 9027 (0.13%)
    10 / 9010 (0.11%)
         occurrences causally related to treatment / all
    1 / 15
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    3 / 9027 (0.03%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    11 / 9027 (0.12%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    2 / 9027 (0.02%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    7 / 9027 (0.08%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    5 / 9027 (0.06%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    3 / 9027 (0.03%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    3 / 9027 (0.03%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    5 / 9027 (0.06%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    3 / 9027 (0.03%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiodysplasia
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic thrombosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dialysis hypotension
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulomatosis with polyangiitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    5 / 9027 (0.06%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accelerated hypertension
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial rupture
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leriche syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (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
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Assisted suicide
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    78 / 9027 (0.86%)
    92 / 9010 (1.02%)
         occurrences causally related to treatment / all
    1 / 99
    0 / 97
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    8 / 9027 (0.09%)
    12 / 9010 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    15 / 9027 (0.17%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    6 / 9027 (0.07%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 9027 (0.01%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Gait disturbance
         subjects affected / exposed
    2 / 9027 (0.02%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 9027 (0.02%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Medical device site haematoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Drowning
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Impaired healing
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion site reaction
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adverse drug reaction
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    10 / 9027 (0.11%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated polyserositis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Physical deconditioning
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    2 / 9027 (0.02%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 9027 (0.00%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytokine storm
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Loss of personal independence in daily activities
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Victim of abuse
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Physical disability
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    4 / 9027 (0.04%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular pain
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic haematoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic pain
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic disorder
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    29 / 9027 (0.32%)
    21 / 9010 (0.23%)
         occurrences causally related to treatment / all
    0 / 41
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Dyspnoea
         subjects affected / exposed
    13 / 9027 (0.14%)
    17 / 9010 (0.19%)
         occurrences causally related to treatment / all
    0 / 14
    2 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    12 / 9027 (0.13%)
    14 / 9010 (0.16%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Respiratory failure
         subjects affected / exposed
    7 / 9027 (0.08%)
    10 / 9010 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Epistaxis
         subjects affected / exposed
    5 / 9027 (0.06%)
    8 / 9010 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    8 / 9027 (0.09%)
    8 / 9010 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    11 / 9027 (0.12%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    8 / 9027 (0.09%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Asthma
         subjects affected / exposed
    3 / 9027 (0.03%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 9027 (0.00%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    7 / 9027 (0.08%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma-chronic obstructive pulmonary disease overlap syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic abnormal relaxation
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea at rest
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    4 / 9027 (0.04%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Laryngeal oedema
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rales
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal fistula
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alveolar proteinosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal haematoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthopnoea
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (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 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis allergic
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheomalacia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic wound
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 9027 (0.00%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    6 / 9027 (0.07%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tobacco withdrawal symptoms
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder due to a general medical condition
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Depression
         subjects affected / exposed
    4 / 9027 (0.04%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    12 / 9027 (0.13%)
    18 / 9010 (0.20%)
         occurrences causally related to treatment / all
    1 / 13
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    17 / 9027 (0.19%)
    11 / 9010 (0.12%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    12 / 9027 (0.13%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    4 / 12
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 9027 (0.02%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 9027 (0.01%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder rupture
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis obstructive
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic fibrosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis cholestatic
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    4 / 9027 (0.04%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Troponin increased
         subjects affected / exposed
    1 / 9027 (0.01%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 9027 (0.01%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    5 / 9027 (0.06%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza A virus test positive
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level abnormal
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial test positive
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory marker increased
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occult blood positive
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 test positive
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin I increased
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiogram peripheral abnormal
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (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 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urine present
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gram stain positive
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial pressure increased
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcus test positive
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin T increased
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    11 / 9027 (0.12%)
    11 / 9010 (0.12%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    6 / 9027 (0.07%)
    9 / 9010 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    11 / 9027 (0.12%)
    8 / 9010 (0.09%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Head injury
         subjects affected / exposed
    4 / 9027 (0.04%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hip fracture
         subjects affected / exposed
    4 / 9027 (0.04%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    7 / 9027 (0.08%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprocedural myocardial infarction
         subjects affected / exposed
    4 / 9027 (0.04%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    3 / 9027 (0.03%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site haematoma
         subjects affected / exposed
    2 / 9027 (0.02%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac procedure complication
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniofacial fracture
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    4 / 9027 (0.04%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    3 / 9027 (0.03%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular access site haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic leak
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal injury
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal injury
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical burns of eye
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costal cartilage fracture
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eschar
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exposure to SARS-CoV-2
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative thrombosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpericardiotomy syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal transplant failure
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory fume inhalation disorder
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth fracture
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic renal injury
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvovaginal injury
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brachial plexus injury
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    5 / 9027 (0.06%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gas poisoning
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal anastomotic haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyphaema
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc injury
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication circulatory
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural hypotension
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural dizziness
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation proctitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract procedural complication
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Road traffic accident
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal haematoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic arthritis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site dissection
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphatic malformation
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    84 / 9027 (0.93%)
    106 / 9010 (1.18%)
         occurrences causally related to treatment / all
    0 / 89
    0 / 107
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    59 / 9027 (0.65%)
    69 / 9010 (0.77%)
         occurrences causally related to treatment / all
    0 / 63
    0 / 73
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    64 / 9027 (0.71%)
    54 / 9010 (0.60%)
         occurrences causally related to treatment / all
    2 / 67
    0 / 61
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    48 / 9027 (0.53%)
    48 / 9010 (0.53%)
         occurrences causally related to treatment / all
    0 / 53
    0 / 50
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    27 / 9027 (0.30%)
    23 / 9010 (0.26%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    21 / 9027 (0.23%)
    20 / 9010 (0.22%)
         occurrences causally related to treatment / all
    0 / 24
    1 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    29 / 9027 (0.32%)
    19 / 9010 (0.21%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    16 / 9027 (0.18%)
    14 / 9010 (0.16%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    19 / 9027 (0.21%)
    14 / 9010 (0.16%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    23 / 9027 (0.25%)
    14 / 9010 (0.16%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial flutter
         subjects affected / exposed
    15 / 9027 (0.17%)
    12 / 9010 (0.13%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    13 / 9027 (0.14%)
    11 / 9010 (0.12%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Pericarditis
         subjects affected / exposed
    6 / 9027 (0.07%)
    10 / 9010 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    6 / 9027 (0.07%)
    10 / 9010 (0.11%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery stenosis
         subjects affected / exposed
    7 / 9027 (0.08%)
    9 / 9010 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    6 / 9027 (0.07%)
    8 / 9010 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    10 / 9027 (0.11%)
    8 / 9010 (0.09%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    8 / 9027 (0.09%)
    8 / 9010 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    12 / 9027 (0.13%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    5 / 9027 (0.06%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    4 / 9027 (0.04%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    8 / 9027 (0.09%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    5 / 9027 (0.06%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    4 / 9027 (0.04%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    4 / 9027 (0.04%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    6 / 9027 (0.07%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Torsade de pointes
         subjects affected / exposed
    2 / 9027 (0.02%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    7 / 9027 (0.08%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    5 / 9027 (0.06%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    6 / 9027 (0.07%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    5 / 9027 (0.06%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postinfarction angina
         subjects affected / exposed
    6 / 9027 (0.07%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    3 / 9027 (0.03%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 9027 (0.02%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure chronic
         subjects affected / exposed
    4 / 9027 (0.04%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery perforation
         subjects affected / exposed
    0 / 9027 (0.00%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    3 / 9027 (0.03%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    3 / 9027 (0.03%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    5 / 9027 (0.06%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial injury
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    5 / 9027 (0.06%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac asthma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac discomfort
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic coronary syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    4 / 9027 (0.04%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Low cardiac output syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve disease
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial rupture
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial haemorrhage
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anginal equivalent
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac dysfunction
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiorenal syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial mass
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricle rupture
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    26 / 9027 (0.29%)
    23 / 9010 (0.26%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    10 / 9027 (0.11%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    5 / 9027 (0.06%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    5 / 9027 (0.06%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 9027 (0.00%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    4 / 9027 (0.04%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    10 / 9027 (0.11%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    4 / 9027 (0.04%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    4 / 9027 (0.04%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Amnesia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia haemorrhage
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain oedema
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid sinus syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery stenosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    4 / 9027 (0.04%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cerebral ischaemia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebrovascular insufficiency
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic coma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness postural
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic transformation stroke
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic encephalopathy
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post stroke epilepsy
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudoradicular syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery aneurysm
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral atrophy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral thrombosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dystonia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    39 / 9027 (0.43%)
    40 / 9010 (0.44%)
         occurrences causally related to treatment / all
    1 / 43
    0 / 45
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    8 / 9027 (0.09%)
    9 / 9010 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    0 / 9027 (0.00%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymph node pain
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired haemophilia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic disorder
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    3 / 9027 (0.03%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness neurosensory
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness unilateral
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    4 / 9027 (0.04%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye allergy
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy hypertensive
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacrimation increased
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Purtscher retinopathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tolosa-Hunt syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    19 / 9027 (0.21%)
    13 / 9010 (0.14%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Gastritis
         subjects affected / exposed
    7 / 9027 (0.08%)
    10 / 9010 (0.11%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    8 / 9027 (0.09%)
    8 / 9010 (0.09%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    3 / 9027 (0.03%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 9027 (0.03%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    4 / 9027 (0.04%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal haemorrhage
         subjects affected / exposed
    5 / 9027 (0.06%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    7 / 9027 (0.08%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    12 / 9027 (0.13%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    2 / 15
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    2 / 9027 (0.02%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 9027 (0.06%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    6 / 9027 (0.07%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    3 / 9027 (0.03%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    8 / 9027 (0.09%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    3 / 9027 (0.03%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 9027 (0.02%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis
         subjects affected / exposed
    5 / 9027 (0.06%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    5 / 9027 (0.06%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal polyp haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Ileus
         subjects affected / exposed
    0 / 9027 (0.00%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    4 / 9027 (0.04%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    3 / 9027 (0.03%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    4 / 9027 (0.04%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vomiting
         subjects affected / exposed
    4 / 9027 (0.04%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphthous ulcer
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental caries
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric antral vascular ectasia
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal polyp
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal vascular malformation haemorrhagic
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heyde's syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer haemorrhage
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    5 / 9027 (0.06%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peptic ulcer
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal hypertensive gastropathy
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gastroparesis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis haemorrhagic
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal erosion
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal toxicity
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery stenosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Noninfective sialoadenitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    4 / 9027 (0.04%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic atrophy
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reflux gastritis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    6 / 9027 (0.07%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    5 / 9027 (0.06%)
    8 / 9010 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dermal cyst
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotic angiodermatitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panniculitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis contact
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ingrowing nail
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash pruritic
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (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 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    66 / 9027 (0.73%)
    68 / 9010 (0.75%)
         occurrences causally related to treatment / all
    5 / 71
    10 / 72
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Renal impairment
         subjects affected / exposed
    14 / 9027 (0.16%)
    15 / 9010 (0.17%)
         occurrences causally related to treatment / all
    1 / 17
    2 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    10 / 9027 (0.11%)
    14 / 9010 (0.16%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    14 / 9027 (0.16%)
    12 / 9010 (0.13%)
         occurrences causally related to treatment / all
    1 / 14
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    6 / 9027 (0.07%)
    11 / 9010 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    6 / 9027 (0.07%)
    10 / 9010 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    8 / 9027 (0.09%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    4 / 9027 (0.04%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    2 / 9027 (0.02%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder disorder
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelocaliectasis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bladder diverticulum
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder tamponade
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urethral
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis erosive
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (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
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurogenic bladder
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal salt-wasting syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vesical fistula
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaldosteronism
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenocortical insufficiency acute
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (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
    Bladder transitional cell carcinoma
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paget's disease of nipple
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypopharyngeal cancer recurrent
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    15 / 9027 (0.17%)
    8 / 9010 (0.09%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 9027 (0.02%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    5 / 9027 (0.06%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    4 / 9027 (0.04%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 9027 (0.02%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    3 / 9027 (0.03%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    3 / 9027 (0.03%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    2 / 9027 (0.02%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    5 / 9027 (0.06%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma muscle
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc space narrowing
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue necrosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (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
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal synovial cyst
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    89 / 9027 (0.99%)
    97 / 9010 (1.08%)
         occurrences causally related to treatment / all
    0 / 93
    0 / 99
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    COVID-19 pneumonia
         subjects affected / exposed
    46 / 9027 (0.51%)
    52 / 9010 (0.58%)
         occurrences causally related to treatment / all
    0 / 47
    0 / 52
         deaths causally related to treatment / all
    0 / 12
    0 / 13
    COVID-19
         subjects affected / exposed
    48 / 9027 (0.53%)
    42 / 9010 (0.47%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 42
         deaths causally related to treatment / all
    0 / 8
    0 / 10
    Urinary tract infection
         subjects affected / exposed
    36 / 9027 (0.40%)
    37 / 9010 (0.41%)
         occurrences causally related to treatment / all
    1 / 39
    0 / 38
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    26 / 9027 (0.29%)
    26 / 9010 (0.29%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 26
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Urosepsis
         subjects affected / exposed
    8 / 9027 (0.09%)
    12 / 9010 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Gastroenteritis
         subjects affected / exposed
    7 / 9027 (0.08%)
    12 / 9010 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cellulitis
         subjects affected / exposed
    17 / 9027 (0.19%)
    9 / 9010 (0.10%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    6 / 9027 (0.07%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 9027 (0.02%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    23 / 9027 (0.25%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 7
         deaths causally related to treatment / all
    0 / 12
    0 / 3
    Osteomyelitis
         subjects affected / exposed
    7 / 9027 (0.08%)
    6 / 9010 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    7 / 9027 (0.08%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    4 / 9027 (0.04%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    5 / 9027 (0.06%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 9027 (0.04%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    6 / 9027 (0.07%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 9027 (0.01%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diverticulitis
         subjects affected / exposed
    7 / 9027 (0.08%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    3 / 9027 (0.03%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    2 / 9027 (0.02%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    6 / 9027 (0.07%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    3 / 9027 (0.03%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    4 / 9027 (0.04%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parapharyngeal space infection
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 9027 (0.00%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urinary tract infection bacterial
         subjects affected / exposed
    2 / 9027 (0.02%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 9027 (0.01%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acarodermatitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortitis syphilitic
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Babesiosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chikungunya virus infection
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus pneumonia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysematous cystitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin infection
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Klebsiella urinary tract infection
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site joint infection
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory tract infection bacterial
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonella sepsis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         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
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site infection
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial prostatitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Citrobacter sepsis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis klebsiella
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis enterococcal
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter pneumonia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelothrix sepsis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gas gangrene
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Giardiasis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis B
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    3 / 9027 (0.03%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (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
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal abscess
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia acinetobacter
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyonephrosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyuria
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal abscess
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strongyloidiasis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (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 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular device infection
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    4 / 9027 (0.04%)
    12 / 9010 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hyperglycaemia
         subjects affected / exposed
    14 / 9027 (0.16%)
    10 / 9010 (0.11%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    6 / 9027 (0.07%)
    9 / 9010 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    6 / 9027 (0.07%)
    7 / 9010 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    3 / 9027 (0.03%)
    5 / 9010 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 9027 (0.00%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    9 / 9027 (0.10%)
    4 / 9010 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 9027 (0.01%)
    3 / 9010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    4 / 9027 (0.04%)
    2 / 9010 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abnormal loss of weight
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic metabolic decompensation
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Euglycaemic diabetic ketoacidosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperinsulinaemic hypoglycaemia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    3 / 9027 (0.03%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    0 / 9027 (0.00%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    2 / 9027 (0.02%)
    1 / 9010 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    2 / 9027 (0.02%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (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 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 9027 (0.01%)
    0 / 9010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo CSL112
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 9027 (0.00%)
    0 / 9010 (0.00%)

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Sep 2019
    The list below describes key changes to the Clinical Study Protocol: • Modified the primary endpoint to include all MI events instead of only type 1 (spontaneous) MI events. • In the original protocol (dated 23 January 2018) for Inclusion Criteria 6, participants were required to have at least 1 of the following established risk factors: age >= 65 years, prior history of MI, diabetes mellitus requiring pharmacotherapy, or peripheral artery disease. Modification of Inclusion Criteria 6 utilized the same risk factors but instead required the presence of diabetes mellitus requiring pharmacotherapy, or 2 or more of the following: age >= 65 years, prior history of MI, and peripheral artery disease. This modification to Inclusion Criteria 6 was implemented to limit enrollment to participants that were at an even higher risk of an early recurrent cardiovascular event. • Included additional secondary and exploratory endpoints. • Specified that the 70% interim analysis would not be performed if the expected IDMC review of the interim analysis was less than 2 months prior to the anticipated completion of enrollment. • Included the option to limit the number of participants enrolled with a specific index MI type (ie, STEMI or NSTEMI). • Added updated nonclinical data as well as clinical data from Study CSL112_1002. • Modified wording to provide clarifications and improve protocol compliance.

    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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