Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

    Summary
    EudraCT number
    		 2012-000061-21
    Trial protocol
    		 GB   SK   EE   DE   BE   SE   HU   AT   ES   LT   DK   IT   CZ   PL   BG   NL  
    Global end of trial date
    19 Jul 2016

    Results information
    Results version number
    		 v1
    This version publication date
    06 Mar 2018
    First version publication date
    06 Mar 2018
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I1V-MC-EIAN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01687998
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 11949, Trial Alias: I1V-MC-EIAN
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    19 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, mycocardial infarction (MI), storke, coronary revascularization, or hospitalization for unstable angina (UA) in high-risk vascular disease (HRVD) participants.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Sep 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 233
    Country: Number of subjects enrolled
    South Africa: 153
    Country: Number of subjects enrolled
    Spain: 131
    Country: Number of subjects enrolled
    Sweden: 66
    Country: Number of subjects enrolled
    Switzerland: 29
    Country: Number of subjects enrolled
    Taiwan: 105
    Country: Number of subjects enrolled
    Turkey: 3
    Country: Number of subjects enrolled
    Ukraine: 133
    Country: Number of subjects enrolled
    United Kingdom: 116
    Country: Number of subjects enrolled
    United States: 4475
    Country: Number of subjects enrolled
    Argentina: 180
    Country: Number of subjects enrolled
    Australia: 319
    Country: Number of subjects enrolled
    Austria: 68
    Country: Number of subjects enrolled
    Belgium: 84
    Country: Number of subjects enrolled
    Brazil: 110
    Country: Number of subjects enrolled
    Bulgaria: 231
    Country: Number of subjects enrolled
    Canada: 1245
    Country: Number of subjects enrolled
    China: 445
    Country: Number of subjects enrolled
    Czech Republic: 372
    Country: Number of subjects enrolled
    Denmark: 195
    Country: Number of subjects enrolled
    Estonia: 59
    Country: Number of subjects enrolled
    France: 97
    Country: Number of subjects enrolled
    Germany: 400
    Country: Number of subjects enrolled
    Hong Kong: 52
    Country: Number of subjects enrolled
    Hungary: 233
    Country: Number of subjects enrolled
    Israel: 146
    Country: Number of subjects enrolled
    Italy: 83
    Country: Number of subjects enrolled
    Japan: 407
    Country: Number of subjects enrolled
    Korea, Republic of: 181
    Country: Number of subjects enrolled
    Lithuania: 28
    Country: Number of subjects enrolled
    Mexico: 466
    Country: Number of subjects enrolled
    Netherlands: 340
    Country: Number of subjects enrolled
    New Zealand: 127
    Country: Number of subjects enrolled
    Poland: 483
    Country: Number of subjects enrolled
    Romania: 130
    Country: Number of subjects enrolled
    Russian Federation: 167
    Worldwide total number of subjects
    12092
    EEA total number of subjects
    3349
    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)
    5713
    From 65 to 84 years
    6278
    85 years and over
    101

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 No Text Entered

    Pre-assignment
    Screening details
    		 No Text Entered

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Evacetrapib
    Arm description
    		 Evacetrapib 130 milligram (mg) tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Evacetrapib
    Investigational medicinal product code
    Other name
    LY2484595
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Evacetrapib 130 mg tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).

    Arm title
    		 Placebo
    Arm description
    		 Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo, tablet administered orally once daily for up to 4 years. Participants received standard of care for HRVD.

    Number of subjects in period 1
    		Evacetrapib Placebo
    Started
    6038
    6054
    Received at Least One Dose of Study Drug
    6036
    6052
    Completed
    5926
    5934
    Not completed
    112
    120
         Consent withdrawn by subject
    49
    51
         Alive
    54
    62
         Lost to follow-up
    9
    7

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 12092 12092
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5713 5713
        From 65-84 years
    		 6278 6278
        85 years and over
    		 101 101
    Gender categorical
    Units: Subjects
        Female
    		 2784 2784
        Male
    		 9308 9308
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 469 469
        Asian
    		 1290 1290
        Native Hawaiian or Other Pacific Islander
    		 11 11
        Black or African American
    		 294 294
        White
    		 9904 9904
        More than one race
    		 61 61
        Unknown or Not Reported
    		 63 63
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1022 1022
        Not Hispanic or Latino
    		 10780 10780
        Unknown or Not Reported
    		 290 290

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Evacetrapib
    Reporting group description
    		 Evacetrapib 130 milligram (mg) tablet, administered orally once daily for up to 4 years. Participants will also receive standard of care for high-risk vascular disease (HRVD).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, tablet administered orally once daily for up to 4 years. Participants will also receive standard of care for HRVD.

    Primary: Time to First Occurrence of the Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA) [Time Frame: Baseline to Study Completion (Up to 4 years)]

    		 Close Top of page
    End point title
    		 Time to First Occurrence of the Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA) [Time Frame: Baseline to Study Completion (Up to 4 years)]
    End point description
    Time to first occurrence is the time from baseline to the first occurrence of any component event included in the composite primary endpoint of CV death, MI, stroke, coronary revascularization, or hospitalization for UA. For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
    End point type
    Primary
    End point timeframe
    Baseline to Study Completion (Up to 4 years)
    End point values
    		 Evacetrapib Placebo
    Number of subjects analysed
    6038 [1]
    6054 [2]
    Units: participants
    779
    776
    Notes
    [1] - All randomized participants.
    [2] - All randomized participants.
    Statistical analysis title
    		 Statistical Analysis Composite Primary Endpoint
    Comparison groups
    Evacetrapib v Placebo
    Number of subjects included in analysis
    12092
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9054
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.006
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.911
         upper limit
    		 1.111

    Secondary: Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels

    		 Close Top of page
    End point title
    		 Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, 3 Months
    End point values
    		 Evacetrapib Placebo
    Number of subjects analysed
    6038 [3]
    6054 [4]
    Units: Percent
    arithmetic mean (standard deviation)
        LDL-C (n=5760, 5786)
    -31.12 ( 27.583 )
    -5.99 ( 29.007 )
        HDL-C (n=5760, 5788)
    133.18 ( 57.204 )
    1.63 ( 17.455 )
    Notes
    [3] - All randomized participants with evaluable LDL-C levels.
    [4] - All randomized participants with evaluable HDL-C levels.
    Statistical analysis title
    		 Statistical Analysis for LDL-C Levels
    Comparison groups
    Placebo v Evacetrapib
    Number of subjects included in analysis
    12092
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -37.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.15
         upper limit
    		 -36.08
    Statistical analysis title
    		 Statistical Analysis for HDL-C Levels
    Comparison groups
    Evacetrapib v Placebo
    Number of subjects included in analysis
    12092
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    131.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 130.01
         upper limit
    		 133.09

    Secondary: Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA

    		 Close Top of page
    End point title
    		 Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA
    End point description
    Time to first occurrence is the time from baseline to the first occurrence of any component event included in the composite endpoint of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for UA. For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
    End point type
    Secondary
    End point timeframe
    Baseline through End of Study (Up to 4 years)
    End point values
    		 Evacetrapib Placebo
    Number of subjects analysed
    6038
    6054
    Units: participants
    857
    867
    Statistical analysis title
    		 Statistical Analysis Composite Endpoint Mortality
    Comparison groups
    Evacetrapib v Placebo
    Number of subjects included in analysis
    12092
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8463
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.991
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.901
         upper limit
    		 1.089

    Secondary: Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization

    		 Close Top of page
    End point title
    		 Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization
    End point description
    Time to first occurrence is the time from baseline to the first occurrence of any component event included in the composite endpoint. For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
    End point type
    Secondary
    End point timeframe
    Baseline through End of Study (Up to 4 years)
    End point values
    		 Evacetrapib Placebo
    Number of subjects analysed
    6038
    6054
    Units: participants
    690
    691
    Statistical analysis title
    		 Statistical Analysis for CV Death, MI, or Coronary
    Comparison groups
    Placebo v Evacetrapib
    Number of subjects included in analysis
    12092
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9874
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.001
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.901
         upper limit
    		 1.112

    Secondary: Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA

    		 Close Top of page
    End point title
    		 Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline through End of Study (Up to 4 years)
    End point values
    		 Evacetrapib Placebo
    Number of subjects analysed
    6038
    6054
    Units: participants
    571
    570
    Statistical analysis title
    		 Statistical Analysis for CV Death, MI, Stroke
    Comparison groups
    Evacetrapib v Placebo
    Number of subjects included in analysis
    12092
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9574
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.893
         upper limit
    		 1.127

    Secondary: Time to First Occurrence of Triple Composite Endpoint of CV Death, MI, or Stroke

    		 Close Top of page
    End point title
    		 Time to First Occurrence of Triple Composite Endpoint of CV Death, MI, or Stroke
    End point description
    Time to first occurrence is the time from baseline to the first occurrence of any component event included in the composite endpoint. For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.
    End point type
    Secondary
    End point timeframe
    Baseline through End of Study (Up to 4 years)
    End point values
    		 Evacetrapib Placebo
    Number of subjects analysed
    6038
    6054
    Units: participants
    437
    453
    Statistical analysis title
    		 Statistical Analysis for Triple Composite
    Comparison groups
    Evacetrapib v Placebo
    Number of subjects included in analysis
    12092
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5917
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.965
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.846
         upper limit
    		 1.1

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I1V-MC-EIAN
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    TR1_LY2484595-130mg
    Reporting group description
    		 -

    Reporting group title
    TR2_PLACEBO
    Reporting group description
    		 -

    Serious adverse events
    		 TR1_LY2484595-130mg TR2_PLACEBO
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2306 / 6036 (38.20%)
    2341 / 6052 (38.68%)
         number of deaths (all causes)
    240
    287
         number of deaths resulting from adverse events
    8
    5
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    acute myeloid leukaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    adenocarcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    adenocarcinoma gastric
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    adenocarcinoma of colon
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    adenocarcinoma pancreas
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    adenosquamous cell lung cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    anal squamous cell carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anaplastic astrocytoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    b-cell lymphoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    b-cell lymphoma stage iv
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    17 / 6036 (0.28%)
    13 / 6052 (0.21%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    basosquamous carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    benign gastric neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    benign neoplasm of adrenal gland
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    benign neoplasm of spinal cord
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    benign neoplasm of thyroid gland
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    benign renal neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bladder cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bladder cancer recurrent
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bladder neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bladder transitional cell carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    borderline mucinous tumour of ovary
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bowen's disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    breast cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    breast cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchial carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    bronchial neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    burkitt's lymphoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    buschke-lowenstein's tumour
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carcinoid tumour
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carcinoid tumour of the gastrointestinal tract
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cervix carcinoma stage 0
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [1]
    1 / 1388 (0.07%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholangiocarcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    chronic lymphocytic leukaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic lymphocytic leukaemia stage 0
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic myeloid leukaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colon adenoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colon cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colon cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    colon cancer stage 0
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colon cancer stage iii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colon cancer stage iv
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colorectal cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colorectal cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colorectal cancer stage iv
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    desmoplastic melanoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diffuse large b-cell lymphoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diffuse large b-cell lymphoma recurrent
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    diffuse large b-cell lymphoma stage ii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diffuse large b-cell lymphoma stage iii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endometrial adenocarcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ewing's sarcoma metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fallopian tube cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [2]
    0 / 6036 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fibrous histiocytoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gallbladder adenocarcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric adenoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 7
         deaths causally related to treatment / all
    1 / 1
    0 / 2
    gastrointestinal cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal stromal tumour
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal tract adenoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrooesophageal cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    gingival cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    glioblastoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    haemangioma of liver
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatic cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    hepatic cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    hepatocellular carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    hodgkin's disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hodgkin's disease stage iv
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal adenocarcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    invasive breast carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    invasive lobular breast carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    kaposi's sarcoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    keratinising squamous cell carcinoma of nasopharynx
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    keratoacanthoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestine benign neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    laryngeal cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    laryngeal neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    laryngeal squamous cell carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lip squamous cell carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lipoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung adenocarcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    lung adenocarcinoma stage i
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung adenocarcinoma stage ii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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 iii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    lung carcinoma cell type unspecified recurrent
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung carcinoma cell type unspecified stage ii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung carcinoma cell type unspecified stage iii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung carcinoma cell type unspecified stage iv
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    lung neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung neoplasm malignant
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    14 / 6036 (0.23%)
    13 / 6052 (0.21%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 13
         deaths causally related to treatment / all
    0 / 7
    1 / 8
    lung squamous cell carcinoma metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung squamous cell carcinoma stage i
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung squamous cell carcinoma stage iii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lymphocytic lymphoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lymphoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    malignant fibrous histiocytoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malignant melanoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malignant melanoma in situ
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malignant neoplasm of unknown primary site
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malignant neoplasm progression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    malignant pleural effusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mediastinum neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    meningioma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    meningioma malignant
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    metastases to bone
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metastases to central nervous system
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    metastases to liver
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metastases to lung
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metastases to lymph nodes
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metastases to salivary gland
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metastatic malignant melanoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    metastatic squamous cell carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myelodysplastic syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    myxofibrosarcoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nasal sinus cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nasopharyngeal cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neoplasm progression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neoplasm prostate
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [3]
    0 / 6036 (0.00%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neoplasm skin
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neuroendocrine carcinoma metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    neuroendocrine tumour
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    non-hodgkin's lymphoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    non-small cell lung cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    non-small cell lung cancer stage iii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-small cell lung cancer stage iiia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-small cell lung cancer stage iv
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    oesophageal adenocarcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    oesophageal adenocarcinoma metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    oesophageal adenocarcinoma stage 0
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophageal carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    oral cavity cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oropharyngeal cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oropharyngeal squamous cell carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatic carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    pancreatic carcinoma metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    pancreatic neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatic neuroendocrine tumour
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    papillary thyroid cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    parathyroid tumour benign
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    phaeochromocytoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pituitary tumour
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    polycythaemia vera
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [4]
    26 / 4648 (0.56%)
    28 / 4658 (0.60%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [5]
    0 / 6036 (0.00%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer recurrent
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [6]
    3 / 4648 (0.06%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer stage ii
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [7]
    2 / 4648 (0.04%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer stage iv
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [8]
    0 / 6036 (0.00%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostatic adenoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [9]
    1 / 4648 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal adenocarcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    rectal cancer stage 0
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal cancer recurrent
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    renal cell carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    sinonasal papilloma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    skin cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small cell lung cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    small cell lung cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    spinal cord neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    squamous cell carcinoma of lung
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    squamous cell carcinoma of the oral cavity
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    squamous cell carcinoma of the tongue
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    squamous cell carcinoma of the vulva
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    t-cell lymphoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    testicular neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [10]
    1 / 4648 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    testicular seminoma (pure)
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [11]
    0 / 6036 (0.00%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    throat cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    thymoma malignant
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thyroid cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thyroid neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tongue carcinoma stage iv
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tongue neoplasm malignant stage unspecified
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tonsil cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tonsil cancer metastatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transitional cell carcinoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transitional cell carcinoma recurrent
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ureteric cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    uterine cancer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [12]
    0 / 6036 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    uterine leiomyoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [13]
    1 / 1388 (0.07%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    uterine neoplasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [14]
    0 / 6036 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    accelerated hypertension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aneurysm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic aneurysm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    18 / 6036 (0.30%)
    14 / 6052 (0.23%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic aneurysm rupture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    aortic dissection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic elongation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic rupture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    aortic stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    18 / 6036 (0.30%)
    17 / 6052 (0.28%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    aortitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arterial disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arterial haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arterial insufficiency
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arterial occlusive disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arterial perforation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arterial stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arterial thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arteriosclerosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    artery dissection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    axillary vein thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    blood pressure inadequately controlled
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    brachiocephalic artery stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    circulatory collapse
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    deep vein thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    16 / 6052 (0.26%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dry gangrene
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    embolism arterial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    extremity necrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femoral artery aneurysm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femoral artery occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femoral artery perforation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    21 / 6036 (0.35%)
    18 / 6052 (0.30%)
         occurrences causally related to treatment / all
    1 / 23
    2 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertensive crisis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    9 / 6036 (0.15%)
    14 / 6052 (0.23%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertensive emergency
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    17 / 6052 (0.28%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypovolaemic shock
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    iliac artery occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    iliac artery rupture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intermittent claudication
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    16 / 6052 (0.26%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    jugular vein thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lymphatic fistula
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lymphorrhoea
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malignant hypertension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    orthostatic hypotension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    52 / 6036 (0.86%)
    50 / 6052 (0.83%)
         occurrences causally related to treatment / all
    0 / 66
    1 / 66
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    peripheral artery aneurysm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral artery stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    19 / 6036 (0.31%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral artery thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral embolism
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral ischaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    12 / 6036 (0.20%)
    20 / 6052 (0.33%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    peripheral vascular disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    21 / 6036 (0.35%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    shock
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    shock haemorrhagic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    subclavian artery occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subclavian artery stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subclavian artery thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    temporal arteritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombophlebitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombophlebitis superficial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    varicose vein
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vasculitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vena cava thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    venous thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    venous thrombosis limb
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    abdominal hernia repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    adrenalectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    amputation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    analgesic therapy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aneurysm repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angioplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    12 / 6036 (0.20%)
    8 / 6052 (0.13%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ankle arthroplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic aneurysm repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic bypass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic valve repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic valve replacement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arterial stent insertion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atherectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial septal defect repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    autonomic nerve operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bladder neck suspension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [15]
    1 / 1388 (0.07%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bone operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchial lesion excision
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cancer surgery
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac ablation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac pacemaker battery replacement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac pacemaker insertion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac pacemaker replacement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac rehabilitation therapy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac resynchronisation therapy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardioversion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carotid angioplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carotid endarterectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carotid revascularisation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carpal tunnel decompression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cataract operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    catheter placement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholecystectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colostomy closure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary angioplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    13 / 6036 (0.22%)
    21 / 6052 (0.35%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary arterial stent insertion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    12 / 6052 (0.20%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary artery bypass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    54 / 6036 (0.89%)
    59 / 6052 (0.97%)
         occurrences causally related to treatment / all
    0 / 54
    0 / 59
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary revascularisation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    82 / 6036 (1.36%)
    79 / 6052 (1.31%)
         occurrences causally related to treatment / all
    0 / 92
    0 / 89
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cox-maze procedure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    debridement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diaphragmatic operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    elective surgery
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endarterectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endovenous ablation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    explorative laparotomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    exploratory operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    eye operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    foot amputation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric bypass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal endoscopic therapy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haematoma evacuation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    heart valve replacement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hernia repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    high frequency ablation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hip arthroplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hip surgery
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hospitalisation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hysterectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [16]
    1 / 1388 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    implantable defibrillator insertion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    13 / 6052 (0.21%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    implantable defibrillator replacement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    incisional drainage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    incisional hernia repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    inguinal hernia repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intervertebral disc operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intraocular lens implant
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    joint arthroplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    knee arthroplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    12 / 6036 (0.20%)
    12 / 6052 (0.20%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    knee operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    leg amputation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lens extraction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lipoma excision
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mastectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    medical device change
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    medical device removal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mitral valve replacement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nephrectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    open reduction of fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteosynthesis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteotomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreaticoduodenectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    penile repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [17]
    0 / 6036 (0.00%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    percutaneous coronary intervention
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    192 / 6036 (3.18%)
    182 / 6052 (3.01%)
         occurrences causally related to treatment / all
    1 / 217
    1 / 214
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral artery angioplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral artery bypass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral artery stent insertion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral endarterectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral nerve transposition
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral revascularisation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate ablation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostatectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [18]
    0 / 6036 (0.00%)
    2 / 4658 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    radioactive iodine therapy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal prolapse repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal artery angioplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal sympathetic nerve ablation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    resection of rectum
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    resuscitation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    retinopexy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rotator cuff repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    shoulder arthroplasty
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    shoulder operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    skin neoplasm excision
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal decompression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal fusion surgery
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal laminectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stent placement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sympathectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tenotomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    therapeutic embolisation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    therapy cessation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombosis prophylaxis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thyroidectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    toe amputation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tongue operation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    total adrenalectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transmyocardial revascularisation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transurethral bladder resection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transurethral prostatectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [19]
    2 / 4648 (0.04%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tricuspid valve repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tumour excision
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ureteral stent insertion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ureteral stent removal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vaginal prolapse repair
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [20]
    1 / 1388 (0.07%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    valvuloplasty cardiac
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular graft
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    venous stent insertion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricular assist device insertion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vitrectomy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound drainage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    abortion spontaneous
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [21]
    0 / 6036 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pregnancy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [22]
    0 / 6036 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    adverse drug reaction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    asthenia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac death
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 5
    chest discomfort
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    12 / 6052 (0.20%)
         occurrences causally related to treatment / all
    0 / 7
    2 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chest pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    37 / 6036 (0.61%)
    34 / 6052 (0.56%)
         occurrences causally related to treatment / all
    3 / 38
    0 / 42
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    death
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    20 / 6036 (0.33%)
    14 / 6052 (0.23%)
         occurrences causally related to treatment / all
    2 / 20
    0 / 14
         deaths causally related to treatment / all
    2 / 20
    0 / 14
    device breakage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device dislocation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device end of service
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device inappropriate shock delivery
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device malfunction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device material issue
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    drowning
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    drug withdrawal syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    exercise tolerance decreased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gait disturbance
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    general physical health deterioration
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    generalised oedema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    granuloma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperthermia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertrophy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypothermia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    impaired healing
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    implant site haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    incarcerated hernia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ischaemic ulcer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lead dislodgement
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    multi-organ failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    necrobiosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    necrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    107 / 6036 (1.77%)
    108 / 6052 (1.78%)
         occurrences causally related to treatment / all
    1 / 123
    1 / 118
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oedema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oedema peripheral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pelvic mass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral swelling
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    precancerous mucosal lesion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stent-graft endoleak
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sudden cardiac death
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    16 / 6036 (0.27%)
    15 / 6052 (0.25%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 15
         deaths causally related to treatment / all
    0 / 16
    0 / 15
    sudden death
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    systemic inflammatory response syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombosis in device
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ulcer haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular stent occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular stent restenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular stent stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular stent thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vessel puncture site haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    anaphylactic reaction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anaphylactic shock
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    drug hypersensitivity
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypersensitivity
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    amastia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [23]
    10 / 4648 (0.22%)
    12 / 4658 (0.26%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    cervical polyp
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [24]
    0 / 6036 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cystocele
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [25]
    1 / 1388 (0.07%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dysmenorrhoea
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [26]
    0 / 6036 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    menometrorrhagia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [27]
    0 / 6036 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ovarian cyst
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [28]
    2 / 1388 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    penile necrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [29]
    0 / 6036 (0.00%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peyronie's disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [30]
    1 / 4648 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostatitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [31]
    4 / 4648 (0.09%)
    2 / 4658 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectocele
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [32]
    0 / 6036 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    testicular disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [33]
    1 / 4648 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    uterine polyp
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [34]
    1 / 1388 (0.07%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    uterine prolapse
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [35]
    2 / 1388 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute pulmonary oedema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    acute respiratory distress syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    acute respiratory failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    14 / 6036 (0.23%)
    20 / 6052 (0.33%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 20
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    alveolitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    asphyxia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    aspiration
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    asthma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atelectasis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchiectasis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchitis chronic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchospasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    43 / 6036 (0.71%)
    47 / 6052 (0.78%)
         occurrences causally related to treatment / all
    0 / 55
    0 / 55
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    chylothorax
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cough
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    26 / 6036 (0.43%)
    23 / 6052 (0.38%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspnoea exertional
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    emphysema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    epistaxis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemoptysis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemothorax
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hiccups
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hydrothorax
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypercapnia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoxia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    idiopathic pulmonary fibrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    interstitial lung disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung consolidation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung infiltration
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mediastinal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    nasal septum deviation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    organising pneumonia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pickwickian syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    12 / 6052 (0.20%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    pleurisy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleuritic pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumomediastinum
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia aspiration
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    8 / 6052 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    pneumonitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumothorax spontaneous
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary alveolar haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary arterial hypertension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary congestion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    21 / 6036 (0.35%)
    20 / 6052 (0.33%)
         occurrences causally related to treatment / all
    1 / 22
    1 / 20
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    pulmonary fibrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    pulmonary hypertension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary mass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    pulmonary oedema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    8 / 6052 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory arrest
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    respiratory distress
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    17 / 6036 (0.28%)
    16 / 6052 (0.26%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 17
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tracheomalacia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    abnormal behaviour
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    acute psychosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    acute stress disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    adjustment disorder with anxiety
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    adjustment disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    adjustment disorder with depressed mood
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    adjustment disorder with mixed disturbance of emotion and conduct
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aggression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    alcohol abuse
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    alcohol withdrawal syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    alcoholism
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anxiety
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anxiety disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    completed suicide
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    confusional state
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    delirium
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    delirium tremens
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    depression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    depression suicidal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    generalised anxiety disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hallucination
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypomania
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    major depression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mental disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    13 / 6052 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    panic attack
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post-traumatic stress disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    psychogenic seizure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    psychotic disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    autoimmune hepatitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bile duct obstruction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    bile duct stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bile duct stone
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    biliary colic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    biliary tract disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholangitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholangitis acute
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholecystitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    19 / 6036 (0.31%)
    16 / 6052 (0.26%)
         occurrences causally related to treatment / all
    0 / 20
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholecystitis acute
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    12 / 6036 (0.20%)
    15 / 6052 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholecystitis chronic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    23 / 6036 (0.38%)
    22 / 6052 (0.36%)
         occurrences causally related to treatment / all
    0 / 23
    1 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholestasis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gallbladder disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatic cirrhosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    hepatic lesion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatic steatosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatitis alcoholic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatomegaly
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hydrocholecystis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ischaemic hepatitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    jaundice
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    jaundice cholestatic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    jaundice extrahepatic obstructive
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    liver disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    liver injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    portal vein thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angiogram
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anticoagulation drug level above therapeutic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arteriogram
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arteriogram coronary
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    16 / 6036 (0.27%)
    17 / 6052 (0.28%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arteriogram renal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    biopsy brain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    blood glucose decreased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    blood glucose increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    blood osmolarity decreased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    blood pressure increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac function test
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac stress test abnormal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiovascular evaluation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiovascular examination
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carotid bruit
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    catheterisation cardiac
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    10 / 6036 (0.17%)
    14 / 6052 (0.23%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clostridium test positive
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colonoscopy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    computerised tomogram
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    computerised tomogram thorax
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diagnostic procedure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ejection fraction decreased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    electrocardiogram abnormal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    electrocardiogram qt prolonged
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endoscopy gastrointestinal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemoglobin decreased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    heart rate irregular
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    international normalised ratio decreased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    international normalised ratio increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    investigation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    liver function test abnormal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myocardial necrosis marker increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophagogastroduodenoscopy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral arteriogram
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostatic specific antigen increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [36]
    2 / 4648 (0.04%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transaminases increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    troponin increased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ureteroscopy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vitamin b12 decreased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    weight decreased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    abdominal wound dehiscence
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    accident
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    accidental exposure to product
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    accidental overdose
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    acetabulum fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    alcohol poisoning
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anaemia postoperative
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anal injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anastomotic stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anastomotic ulcer haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ankle fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    9 / 6036 (0.15%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    back injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    brain contusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cartilage injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    chemical burn of skin
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chemical injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chest injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clavicle fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colon injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    compression fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    concussion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    contrast media reaction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    contusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary artery restenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    craniocerebral injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    crush injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cystitis radiation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    extradural haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    eye injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    facial bones fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    39 / 6036 (0.65%)
    50 / 6052 (0.83%)
         occurrences causally related to treatment / all
    0 / 40
    0 / 53
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femoral neck fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fibula fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    foot fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    foreign body
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fractured sacrum
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal anastomotic complication
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal stoma complication
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    graft thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gun shot wound
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    hand fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    head injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    heat illness
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    humerus fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    incisional hernia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intentional overdose
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    jaw fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    joint dislocation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    joint injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    laceration
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ligament injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ligament sprain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    limb traumatic amputation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lumbar vertebral fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    meniscus injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    multiple fractures
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    multiple injuries
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    muscle contusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    muscle injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    muscle rupture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nerve root injury lumbar
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    overdose
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    patella fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pelvic fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral arterial reocclusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral artery restenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    periprosthetic fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    poisoning
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post concussion syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post laminectomy syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post procedural bile leak
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post procedural haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post procedural haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post procedural myocardial infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post procedural stroke
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative fever
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative ileus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative respiratory failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative thoracic procedure complication
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative wound complication
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    procedural haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    procedural hypotension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pubis fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary contusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    radius fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    8 / 6052 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    15 / 6036 (0.25%)
    15 / 6052 (0.25%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 15
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    seroma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    skull fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    soft tissue injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal compression fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal cord injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal cord injury cervical
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    splenic rupture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sternal fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stoma site haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subdural haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    subdural haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    tendon injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tendon rupture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thermal burn
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thoracic vertebral fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tooth fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    traumatic amputation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    traumatic fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    traumatic haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    traumatic intracranial haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    traumatic liver injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ulna fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper limb fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular graft occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular graft thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular pseudoaneurysm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular pseudoaneurysm ruptured
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    wound
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound complication
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound dehiscence
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wrist fracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    arteriovenous malformation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial septal defect
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dermoid cyst
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hydrocele
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [37]
    0 / 6036 (0.00%)
    2 / 4658 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertrophic cardiomyopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    leukodystrophy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    phimosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [38]
    0 / 6036 (0.00%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    acute coronary syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    9 / 6036 (0.15%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    acute myocardial infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    146 / 6036 (2.42%)
    137 / 6052 (2.26%)
         occurrences causally related to treatment / all
    5 / 168
    4 / 149
         deaths causally related to treatment / all
    0 / 16
    0 / 4
    adams-stokes syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angina pectoris
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    102 / 6036 (1.69%)
    98 / 6052 (1.62%)
         occurrences causally related to treatment / all
    3 / 113
    3 / 103
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angina unstable
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    298 / 6036 (4.94%)
    289 / 6052 (4.78%)
         occurrences causally related to treatment / all
    7 / 389
    6 / 363
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    aortic valve disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    aortic valve incompetence
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic valve sclerosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic valve stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    arrhythmia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    arteriosclerosis coronary artery
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arteriospasm coronary
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial flutter
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    25 / 6036 (0.41%)
    16 / 6052 (0.26%)
         occurrences causally related to treatment / all
    0 / 27
    1 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    86 / 6036 (1.42%)
    78 / 6052 (1.29%)
         occurrences causally related to treatment / all
    1 / 109
    2 / 94
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial tachycardia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrioventricular block
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrioventricular block complete
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    atrioventricular block second degree
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bradyarrhythmia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bradycardia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    11 / 6052 (0.18%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    17 / 6036 (0.28%)
    30 / 6052 (0.50%)
         occurrences causally related to treatment / all
    1 / 18
    0 / 32
         deaths causally related to treatment / all
    1 / 12
    0 / 21
    cardiac discomfort
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    67 / 6036 (1.11%)
    63 / 6052 (1.04%)
         occurrences causally related to treatment / all
    1 / 79
    1 / 78
         deaths causally related to treatment / all
    0 / 9
    0 / 8
    cardiac failure acute
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    cardiac failure chronic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    cardiac failure congestive
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    95 / 6036 (1.57%)
    103 / 6052 (1.70%)
         occurrences causally related to treatment / all
    1 / 134
    0 / 138
         deaths causally related to treatment / all
    0 / 4
    0 / 12
    cardiac tamponade
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 7
         deaths causally related to treatment / all
    0 / 3
    1 / 5
    cardiogenic shock
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 7
         deaths causally related to treatment / all
    1 / 4
    0 / 4
    cardiomyopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    cardiopulmonary failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    cardiorenal syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    cardiovascular insufficiency
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronotropic incompetence
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    conduction disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    congestive cardiomyopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    coronary artery disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    37 / 6036 (0.61%)
    44 / 6052 (0.73%)
         occurrences causally related to treatment / all
    1 / 40
    2 / 45
         deaths causally related to treatment / all
    0 / 3
    1 / 4
    coronary artery dissection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary artery occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary artery stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diastolic dysfunction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dressler's syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    extrasystoles
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertensive heart disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intracardiac thrombus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ischaemic cardiomyopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    left ventricular dysfunction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    left ventricular failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    microvascular coronary artery disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mitral valve incompetence
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mitral valve stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    82 / 6036 (1.36%)
    100 / 6052 (1.65%)
         occurrences causally related to treatment / all
    1 / 88
    0 / 107
         deaths causally related to treatment / all
    0 / 14
    0 / 17
    myocardial ischaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    15 / 6036 (0.25%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    1 / 16
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    myocardial rupture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    nodal rhythm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    palpitations
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pericardial effusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pericardial haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    pericarditis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postinfarction angina
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prinzmetal angina
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    right ventricular failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    sinus arrest
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sinus bradycardia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sinus node dysfunction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    12 / 6036 (0.20%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sinus tachycardia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stress cardiomyopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    supraventricular tachycardia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    systolic dysfunction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tachyarrhythmia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tachycardia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricle rupture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricular arrhythmia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    ventricular extrasystoles
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricular fibrillation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    ventricular hypokinesia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricular tachyarrhythmia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricular tachycardia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    16 / 6036 (0.27%)
    24 / 6052 (0.40%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wolff-parkinson-white syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    acute disseminated encephalomyelitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    amyotrophic lateral sclerosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aphasia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ataxia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    autonomic nervous system imbalance
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    brain injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    brain mass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    brain stem stroke
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carotid arteriosclerosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carotid artery disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carotid artery occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carotid artery stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    21 / 6036 (0.35%)
    39 / 6052 (0.64%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 42
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carotid sinus syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebellar ischaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebellar syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebral arteriosclerosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebral artery occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebral haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    cerebral infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebral ischaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    61 / 6036 (1.01%)
    62 / 6052 (1.02%)
         occurrences causally related to treatment / all
    0 / 63
    0 / 65
         deaths causally related to treatment / all
    0 / 7
    0 / 10
    cerebrovascular insufficiency
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    cervical myelopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cervical radiculopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cognitive disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    complex partial seizures
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    complex regional pain syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dementia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dementia alzheimer's type
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    diabetic neuropathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dizziness
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    embolic cerebral infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    embolic stroke
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    encephalopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    epilepsy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    essential tremor
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    guillain-barre syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemorrhage intracranial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    haemorrhagic stroke
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    haemorrhagic transformation stroke
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    headache
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hemiparesis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoaesthesia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoglycaemic coma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoxic-ischaemic encephalopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    intraventricular haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    25 / 6036 (0.41%)
    18 / 6052 (0.30%)
         occurrences causally related to treatment / all
    1 / 25
    0 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    lacunar infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    loss of consciousness
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lumbar radiculopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lumbosacral radiculopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metabolic encephalopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    migraine
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    moyamoya disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myasthenia gravis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myelitis transverse
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myoclonus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nerve compression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nerve root compression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nervous system disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neuralgia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neuropathy peripheral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    normal pressure hydrocephalus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    paraesthesia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    parkinson's disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    partial seizures
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peroneal nerve palsy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    polyneuropathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post herpetic neuralgia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postictal paralysis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    presyncope
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    quadriparesis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    quadriplegia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    radicular syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    radiculopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    restless legs syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sciatica
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    seizure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal claudication
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal cord compression
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal cord infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal cord oedema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    status epilepticus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    syncope
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    46 / 6036 (0.76%)
    52 / 6052 (0.86%)
         occurrences causally related to treatment / all
    0 / 48
    1 / 54
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thalamus haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombotic stroke
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    toxic encephalopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transient global amnesia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    37 / 6036 (0.61%)
    39 / 6052 (0.64%)
         occurrences causally related to treatment / all
    1 / 44
    0 / 42
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tremor
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    trigeminal neuralgia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    uraemic encephalopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular dementia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular encephalopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vasogenic cerebral oedema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vertebral artery stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vertebrobasilar insufficiency
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vertigo cns origin
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    viith nerve paralysis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vith nerve paralysis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vith nerve paresis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    30 / 6036 (0.50%)
    38 / 6052 (0.63%)
         occurrences causally related to treatment / all
    0 / 31
    2 / 46
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aplastic anaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    coagulopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cytopenia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    disseminated intravascular coagulation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemorrhagic anaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    heparin-induced thrombocytopenia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    immune thrombocytopenic purpura
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    iron deficiency anaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    leukocytosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lymphadenitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lymphadenopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lymphadenopathy mediastinal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    microcytic anaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    normochromic normocytic anaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancytopenia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pernicious anaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    splenic infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spontaneous haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    conductive deafness
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    deafness neurosensory
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ear pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    eustachian tube dysfunction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    meniere's disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    otosclerosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tinnitus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vertigo
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    15 / 6052 (0.25%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vertigo positional
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    age-related macular degeneration
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cataract
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    15 / 6036 (0.25%)
    14 / 6052 (0.23%)
         occurrences causally related to treatment / all
    0 / 19
    2 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cataract nuclear
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    conjunctival haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic retinopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diplopia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ectropion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    entropion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    eye haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    eye pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    eyelid ptosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    glaucoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    idiopathic orbital inflammation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    iridocyclitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    iritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    keratitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    keratopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lens dislocation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    macular fibrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    open angle glaucoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    optic atrophy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    optic ischaemic neuropathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    optic neuropathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    retinal artery occlusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    retinal detachment
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    retinal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    retinopathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    visual acuity reduced
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    visual impairment
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vitreous haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal adhesions
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal compartment syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal distension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal hernia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal mass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    18 / 6036 (0.30%)
    8 / 6052 (0.13%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal pain upper
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal strangulated hernia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal wall cyst
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal wall haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    alcoholic pancreatitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ascites
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic gastritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coeliac artery stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    colitis ischaemic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colitis microscopic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colitis ulcerative
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colonic fistula
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    constipation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    8 / 6052 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    crohn's disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dieulafoy's vascular malformation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diverticular perforation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diverticulum
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diverticulum intestinal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diverticulum intestinal haemorrhagic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    duodenal stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    duodenal ulcer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    duodenal ulcer haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    duodenal ulcer perforation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    duodenitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspepsia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dysphagia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    enteritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    enterocolitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    enterovesical fistula
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    erosive oesophagitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    faecal incontinence
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    faecaloma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femoral hernia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    food poisoning
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric cyst
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric polyps
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric ulcer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric ulcer haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    10 / 6036 (0.17%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric ulcer perforation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastritis alcoholic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastritis erosive
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastritis haemorrhagic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    gastrointestinal angiodysplasia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal angiodysplasia haemorrhagic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    32 / 6036 (0.53%)
    26 / 6052 (0.43%)
         occurrences causally related to treatment / all
    1 / 32
    0 / 32
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    gastrointestinal inflammation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal ulcer haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    13 / 6036 (0.22%)
    11 / 6052 (0.18%)
         occurrences causally related to treatment / all
    1 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gingival bleeding
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    glossitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haematemesis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    haematochezia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemorrhoidal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemorrhoids
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    heyde's syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hiatus hernia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ileus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    impaired gastric emptying
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    inguinal hernia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    15 / 6036 (0.25%)
    13 / 6052 (0.21%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal infarction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal ischaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal perforation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    intestinal prolapse
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intra-abdominal haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    irritable bowel syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    jejunal perforation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestinal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestinal obstruction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestinal stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestine perforation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestine polyp
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    11 / 6052 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    localised intraabdominal fluid collection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lower gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mallory-weiss syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    melaena
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mesenteric vascular insufficiency
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mouth haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    odynophagia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oedematous pancreatitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophageal achalasia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophageal oedema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophageal spasm
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophageal stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophageal ulcer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophagitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatic mass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatic pseudocyst
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    12 / 6036 (0.20%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    1 / 13
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    10 / 6036 (0.17%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis chronic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis haemorrhagic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis necrotising
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peptic ulcer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peptic ulcer haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peritoneal adhesions
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumoperitoneum
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal polyp
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal ulcer haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    retroperitoneal effusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    retroperitoneal haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    retroperitoneal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    salivary gland mass
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    small intestinal perforation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subileus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    swollen tongue
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tongue haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tongue oedema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    umbilical hernia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    volvulus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    9 / 6036 (0.15%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    angioedema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    decubitus ulcer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dermal cyst
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dermatomyositis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic foot
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    10 / 6036 (0.17%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic neuropathic ulcer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    erythema multiforme
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    henoch-schonlein purpura
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperhidrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperkeratosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypersensitivity vasculitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    psoriasis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rash
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    skin lesion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    skin ulcer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    9 / 6036 (0.15%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urticaria
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vasculitic rash
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    48 / 6036 (0.80%)
    67 / 6052 (1.11%)
         occurrences causally related to treatment / all
    0 / 58
    2 / 81
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    acute prerenal failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    azotaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bladder outlet obstruction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bladder prolapse
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    calculus ureteric
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    calculus urinary
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic kidney disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    9 / 6036 (0.15%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    1 / 10
    3 / 11
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    cystitis haemorrhagic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cystitis ulcerative
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic nephropathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dysuria
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    glomerulonephritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    glomerulosclerosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haematuria
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hydronephrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypotonic urinary bladder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    19 / 6036 (0.31%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nephropathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nephrosclerosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nephrotic syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    obstructive uropathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pelvi-ureteric obstruction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prerenal failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal artery stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal colic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal cyst
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal failure
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    14 / 6036 (0.23%)
    11 / 6052 (0.18%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    renal haematoma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal impairment
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    renal infarct
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal injury
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal tubular necrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal vein thrombosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stress urinary incontinence
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tubulointerstitial nephritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ureteral disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urethral haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urethral stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary bladder haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary incontinence
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary retention
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract obstruction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    autoimmune thyroiditis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    goitre
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperparathyroidism
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperparathyroidism primary
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ankylosing spondylitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arthralgia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    17 / 6052 (0.28%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arthritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    9 / 6036 (0.15%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arthropathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    back pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    15 / 6036 (0.25%)
    14 / 6052 (0.23%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bone pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bursitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cervical spinal stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chondrocalcinosis pyrophosphate
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    compartment syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    costochondritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dupuytren's contracture
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    facet joint syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fibromyalgia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    foot deformity
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gouty arthritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    groin pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemarthrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intervertebral disc degeneration
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intervertebral disc disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    14 / 6052 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    joint instability
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    joint swelling
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    kyphosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ligament laxity
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lumbar spinal stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    13 / 6036 (0.22%)
    23 / 6052 (0.38%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mobility decreased
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    muscle haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    muscle spasms
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    muscular weakness
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    17 / 6036 (0.28%)
    15 / 6052 (0.25%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    musculoskeletal discomfort
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    musculoskeletal pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myalgia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neck pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neuropathic arthropathy
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    osteoarthritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    70 / 6036 (1.16%)
    66 / 6052 (1.09%)
         occurrences causally related to treatment / all
    0 / 76
    1 / 75
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteochondrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteonecrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pain in extremity
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    2 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pain in jaw
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    polymyalgia rheumatica
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pseudarthrosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rhabdomyolysis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rheumatoid arthritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    scoliosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal column stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    spinal osteoarthritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    8 / 6052 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spondylolisthesis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    synovial cyst
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    synovitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tendon disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tendonitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    trigger finger
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vertebral foraminal stenosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    abdominal abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    abdominal wall abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal wall infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abscess limb
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abscess neck
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abscess of salivary gland
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abscess oral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    acute sinusitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anal abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    appendicitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    9 / 6036 (0.15%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    appendicitis perforated
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arteriosclerotic gangrene
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arteritis infective
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arthritis bacterial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atypical pneumonia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bacteraemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bacterial infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bacterial sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    biliary sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    biliary tract infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    breast cellulitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    25 / 6036 (0.41%)
    18 / 6052 (0.30%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchitis viral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bursitis infective
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    41 / 6036 (0.68%)
    42 / 6052 (0.69%)
         occurrences causally related to treatment / all
    0 / 48
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis staphylococcal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholangitis infective
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholecystitis infective
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic sinusitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clostridium difficile colitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    8 / 6052 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clostridium difficile infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clostridium difficile sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colonic abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cystitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic foot infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic gangrene
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    13 / 6036 (0.22%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endocarditis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endocarditis bacterial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endocarditis enterococcal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endophthalmitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    enterobacter infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    enterococcal bacteraemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    enterococcal infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    enterococcal sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    epididymitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [39]
    1 / 4648 (0.02%)
    1 / 4658 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    escherichia bacteraemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    escherichia infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    escherichia pyelonephritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    escherichia sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    escherichia urinary tract infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    extradural abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    febrile infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    folliculitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gallbladder abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gallbladder empyema
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gangrene
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    11 / 6052 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastritis viral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    16 / 6036 (0.27%)
    16 / 6052 (0.26%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis norovirus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis viral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    giardiasis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    graft infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    groin abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    h1n1 influenza
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haematoma infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatitis c
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatitis viral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    herpes zoster
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    implant site cellulitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    implant site infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    incision site infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infected bite
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infected fistula
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infected seroma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infected skin ulcer
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infectious colitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infectious pleural effusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    infective exacerbation of chronic obstructive airways disease
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infusion site cellulitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infusion site infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intervertebral discitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    keratitis bacterial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    klebsiella sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    liver abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    localised infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    lung abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mastoiditis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mediastinitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myelitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nail bed infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    necrotising fasciitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophageal candidiasis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    orbital infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteomyelitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    13 / 6036 (0.22%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteomyelitis acute
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteomyelitis bacterial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteomyelitis chronic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    parainfluenzae virus infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    parotitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    parvovirus infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pelvic abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    penile abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [40]
    1 / 4648 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    perihepatic abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    periodontitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    perirectal abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peritonitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    peritonitis bacterial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peritonsillar abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pharyngitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pilonidal cyst
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    115 / 6036 (1.91%)
    112 / 6052 (1.85%)
         occurrences causally related to treatment / all
    0 / 128
    0 / 122
         deaths causally related to treatment / all
    0 / 7
    0 / 4
    pneumonia bacterial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia chlamydial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia fungal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia influenzal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia legionella
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia parainfluenzae viral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia pneumococcal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia staphylococcal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    pneumonia streptococcal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia viral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post procedural cellulitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (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
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post procedural sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative wound infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    pulmonary tuberculosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyelonephritis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    7 / 6036 (0.12%)
    4 / 6052 (0.07%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyelonephritis acute
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyelonephritis chronic
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory syncytial virus infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory tract infection viral
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rhinovirus infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    salmonellosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    44 / 6036 (0.73%)
    28 / 6052 (0.46%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 32
         deaths causally related to treatment / all
    0 / 7
    0 / 7
    septic shock
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    10 / 6036 (0.17%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    sialoadenitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sinusitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sinusitis fungal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    skin candida
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    soft tissue infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal cord abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    staphylococcal bacteraemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    staphylococcal infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    staphylococcal mediastinitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    staphylococcal sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    streptococcal bacteraemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    streptococcal sepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subcutaneous abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tooth infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tracheobronchitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    19 / 6036 (0.31%)
    32 / 6052 (0.53%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    urinary tract infection bacterial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract infection pseudomonal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urosepsis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    16 / 6036 (0.27%)
    14 / 6052 (0.23%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    vestibular neuronitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    viral infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    3 / 6052 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    viral labyrinthitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound abscess
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound infection bacterial
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound infection staphylococcal
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    15 / 6036 (0.25%)
    26 / 6052 (0.43%)
         occurrences causally related to treatment / all
    1 / 15
    0 / 28
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    diabetes mellitus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    11 / 6036 (0.18%)
    20 / 6052 (0.33%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetes mellitus inadequate control
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    8 / 6036 (0.13%)
    14 / 6052 (0.23%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic ketoacidosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    3 / 6036 (0.05%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic metabolic decompensation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    electrolyte imbalance
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    failure to thrive
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    fluid overload
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gout
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypercalcaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperglycaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    13 / 6036 (0.22%)
    10 / 6052 (0.17%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperkalaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    9 / 6036 (0.15%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    hyperosmolar hyperglycaemic state
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoglycaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    17 / 6036 (0.28%)
    18 / 6052 (0.30%)
         occurrences causally related to treatment / all
    1 / 17
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypokalaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    4 / 6036 (0.07%)
    7 / 6052 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypomagnesaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    9 / 6052 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypovolaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    2 / 6052 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ketoacidosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lactic acidosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malnutrition
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 6036 (0.02%)
    0 / 6052 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metabolic acidosis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 6036 (0.03%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    obesity
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    5 / 6036 (0.08%)
    5 / 6052 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    6 / 6036 (0.10%)
    6 / 6052 (0.10%)
         occurrences causally related to treatment / all
    4 / 6
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vitamin b12 deficiency
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 6036 (0.00%)
    1 / 6052 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in female subjects. The number of subjects exposed has been adjusted accordingly.
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male subjects. The number of subjects exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TR1_LY2484595-130mg TR2_PLACEBO
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2659 / 6036 (44.05%)
    2529 / 6052 (41.79%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    453 / 6036 (7.50%)
    403 / 6052 (6.66%)
         occurrences all number
    508
    466
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    389 / 6036 (6.44%)
    352 / 6052 (5.82%)
         occurrences all number
    435
    407
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    472 / 6036 (7.82%)
    414 / 6052 (6.84%)
         occurrences all number
    568
    484
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    327 / 6036 (5.42%)
    279 / 6052 (4.61%)
         occurrences all number
    367
    304
    dyspnoea
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    305 / 6036 (5.05%)
    307 / 6052 (5.07%)
         occurrences all number
    339
    341
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    375 / 6036 (6.21%)
    370 / 6052 (6.11%)
         occurrences all number
    426
    425
    back pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    399 / 6036 (6.61%)
    379 / 6052 (6.26%)
         occurrences all number
    442
    412
    pain in extremity
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    339 / 6036 (5.62%)
    329 / 6052 (5.44%)
         occurrences all number
    412
    388
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    363 / 6036 (6.01%)
    375 / 6052 (6.20%)
         occurrences all number
    456
    443
    nasopharyngitis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    452 / 6036 (7.49%)
    465 / 6052 (7.68%)
         occurrences all number
    603
    602
    upper respiratory tract infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    327 / 6036 (5.42%)
    327 / 6052 (5.40%)
         occurrences all number
    397
    410

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Nov 01 23:09:23 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA