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:
    A multicentre, international, randomised, parallel group, double blind study to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk. The CAROLINA Trial.

    Summary
    EudraCT number
    		 2009-013157-15
    Trial protocol
    		 BE   FR   DE   PT   CZ   ES   IE   FI   SE   GB   SK   IT   GR   BG  
    Global end of trial date
    21 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Sep 2019
    First version publication date
    06 Sep 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1218.74
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01243424
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate non-inferiority of treatment with linagliptin in comparison with glimepiride (predominantly on metformin background treatment) with respect to time to first occurrence of any of the adjudicated components of the primary composite endpoint, i.e. CV death, non-fatal stroke, or non-fatal myocardial infarction (MI) in patients with T2DM.
    Protection of trial subjects
    Only patients that met all the study inclusion and none of the exclusion criteria were to be randomized in the study. All patients were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all patients was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 82
    Country: Number of subjects enrolled
    Belgium: 151
    Country: Number of subjects enrolled
    Bulgaria: 76
    Country: Number of subjects enrolled
    Brazil: 423
    Country: Number of subjects enrolled
    Switzerland: 14
    Country: Number of subjects enrolled
    Canada: 152
    Country: Number of subjects enrolled
    Colombia: 253
    Country: Number of subjects enrolled
    Czech Republic: 141
    Country: Number of subjects enrolled
    Germany: 658
    Country: Number of subjects enrolled
    Spain: 299
    Country: Number of subjects enrolled
    France: 176
    Country: Number of subjects enrolled
    Georgia: 307
    Country: Number of subjects enrolled
    Greece: 45
    Country: Number of subjects enrolled
    Hungary: 224
    Country: Number of subjects enrolled
    Hong Kong: 141
    Country: Number of subjects enrolled
    Italy: 108
    Country: Number of subjects enrolled
    Israel: 148
    Country: Number of subjects enrolled
    India: 322
    Country: Number of subjects enrolled
    Ireland: 35
    Country: Number of subjects enrolled
    Japan: 145
    Country: Number of subjects enrolled
    Malaysia: 191
    Country: Number of subjects enrolled
    Mexico: 99
    Country: Number of subjects enrolled
    Norway: 217
    Country: Number of subjects enrolled
    Netherlands: 405
    Country: Number of subjects enrolled
    New Zealand: 83
    Country: Number of subjects enrolled
    Portugal: 59
    Country: Number of subjects enrolled
    Peru: 265
    Country: Number of subjects enrolled
    Argentina: 473
    Country: Number of subjects enrolled
    Taiwan: 265
    Country: Number of subjects enrolled
    Chile: 87
    Country: Number of subjects enrolled
    Russian Federation: 163
    Country: Number of subjects enrolled
    Romania: 173
    Country: Number of subjects enrolled
    Korea, Republic of: 277
    Country: Number of subjects enrolled
    Philippines: 136
    Country: Number of subjects enrolled
    Sweden: 295
    Country: Number of subjects enrolled
    Finland: 287
    Country: Number of subjects enrolled
    Slovakia: 70
    Country: Number of subjects enrolled
    Serbia: 123
    Country: Number of subjects enrolled
    Tunisia: 47
    Country: Number of subjects enrolled
    Ukraine: 254
    Country: Number of subjects enrolled
    United Kingdom: 139
    Country: Number of subjects enrolled
    United States: 2401
    Country: Number of subjects enrolled
    South Africa: 197
    Worldwide total number of subjects
    10606
    EEA total number of subjects
    3558
    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)
    5479
    From 65 to 84 years
    5099
    85 years and over
    28

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was multicentre, multinational, randomised, double-blind, double-dummy, parallel group,comparator-controlled trial compared Linagliptin versus (vs.) Glimepiride, predominantly on metformin background treatment in participants with type 2 diabetes mellitus (T2DM) at elevated cardiovascular (CV) risk receiving usual care.

    Pre-assignment
    Screening details
    		 All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be randomised to trial treatment if any one of the specific entry criteria were not met.

    Period 1
    Period 1 title
    Discontinuation From Study (Treated Set)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Carer, Data analyst, Assessor
    Blinding implementation details
    This was a double-blind trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Linagliptin
    Arm description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3028, 5 participants entered/randomised to Linagliptin were not treated. Although 3023 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose, up to an estimated 432 weeks treatment period.

    Arm title
    		 Glimepiride
    Arm description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3014, 4 participants entered/randomised to Glimepiride were not treated. Although 3010 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose, up to an estimated 432 weeks treatment period.

    Number of subjects in period 1 [1]
    		Linagliptin Glimepiride
    Started
    3023
    3010
    Completed
    2899
    2895
    Not completed
    124
    115
         LostToFollowUpfor3P−MACE(StatusAlive
    38
    35
         Consent Withdrawn (Status Unknown)
    14
    12
         Site Closure (Status Alive)
    15
    22
         Site Closure (Status Unknown)
    -
    1
         LostToFollowUpfor3P−MACE(StatusUnknown)
    8
    8
         Consent Withdrawn (Status Alive)
    49
    37
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.
    Period 2
    Period 2 title
    Discontinuation From Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    This was a double-blind trial.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Linagliptin
    Arm description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3028, 5 participants entered/randomised to Linagliptin were not treated. Although 3023 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose, up to an estimated 432 weeks treatment period.

    Arm title
    		 Glimepiride
    Arm description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3014, 4 participants entered/randomised to Glimepiride were not treated. Although 3010 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose, up to an estimated 432 weeks treatment period.

    Number of subjects in period 2
    		Linagliptin Glimepiride
    Started
    3023
    3010
    Completed
    1896
    1832
    Not completed
    1127
    1178
         Consent withdrawn by subject
    309
    328
         Adverse event, non-fatal
    457
    523
         Other than listed above
    230
    211
         Lost to follow-up
    24
    28
         Protocol deviation
    46
    47
         Lack of efficacy
    61
    41

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Linagliptin
    Reporting group description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3028, 5 participants entered/randomised to Linagliptin were not treated. Although 3023 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.

    Reporting group title
    Glimepiride
    Reporting group description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3014, 4 participants entered/randomised to Glimepiride were not treated. Although 3010 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.

    Reporting group values
    		 Linagliptin Glimepiride Total
    Number of subjects
    		 3023 3010
    Age categorical
    Units: Subjects
    Age Continuous
    Treated set (TS): All patients treated with at least one dose of trial drug.
    Units: years
        arithmetic mean (standard deviation)
    		 63.9 ( 9.5 ) 64.2 ( 9.5 ) -
    Sex: Female, Male
    TS
    Units: Subjects
        Female
    		 1185 1229 2414
        Male
    		 1838 1781 3619
    Race (NIH/OMB)
    TS
    Units: Subjects
        American Indian or Alaska Native
    		 106 108 214
        Asian
    		 531 530 1061
        Native Hawaiian or Other Pacific Islander
    		 5 3 8
        Black or African American
    		 155 169 324
        White
    		 2217 2190 4407
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 9 10 19
    Ethnicity (NIH/OMB)
    TS
    Units: Subjects
        Hispanic or Latino
    		 519 513 1032
        Not Hispanic or Latino
    		 2495 2487 4982
        Unknown or Not Reported
    		 9 10 19

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Linagliptin
    Reporting group description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3028, 5 participants entered/randomised to Linagliptin were not treated. Although 3023 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.

    Reporting group title
    Glimepiride
    Reporting group description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3014, 4 participants entered/randomised to Glimepiride were not treated. Although 3010 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.
    Reporting group title
    Linagliptin
    Reporting group description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3028, 5 participants entered/randomised to Linagliptin were not treated. Although 3023 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.

    Reporting group title
    Glimepiride
    Reporting group description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period. Actual number of participants started is 3014, 4 participants entered/randomised to Glimepiride were not treated. Although 3010 were reported to ensure consistent reporting with baseline characteristics that includes only treated participants.

    Subject analysis set title
    Linagliptin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.

    Subject analysis set title
    Glimepiride
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.

    Subject analysis set title
    Linagliptin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.

    Subject analysis set title
    Glimepiride
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.

    Primary: The first 3-point Major Adverse Cardiovascular Events (3P−MACE)

    		 Close Top of page
    End point title
    		 The first 3-point Major Adverse Cardiovascular Events (3P−MACE)
    End point description
    The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented. Treated set (TS): All patients treated with at least one dose of trial drug.
    End point type
    Primary
    End point timeframe
    From randomization until individual day of trial completion, up to 432 weeks
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3023 [1]
    3010 [2]
    Units: Incidence rate/ 1000 patients-years
        number (not applicable)
    20.7
    21.2
    Notes
    [1] - TS
    [2] - TS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the first step in a pre-defined hierarchical testing approach. The upper bound of the confidence interval (CI) of the Hazard ratio (HR) of linagliptin vs. glimepiride was compared with this noninferiority margin for the testing of non-inferiority. All non-inferiority tests were based on a margin of 1.3.
    Comparison groups
    Glimepiride v Linagliptin
    Number of subjects included in analysis
    6033
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.0001 [4]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95.47%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.14
    Notes
    [3] - Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.
    [4] - P-values derived from Wald´s Chi-square test for non-inferiority were calculated.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    This was the second step in a pre-defined hierarchical testing approach.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    6033
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.3813 [6]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95.47%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.14
    Notes
    [5] - Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.
    [6] - P-values derived from Wald´s Chi-square test.

    Secondary: The first 4P−MACE

    		 Close Top of page
    End point title
    		 The first 4P−MACE
    End point description
    The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris.
    End point type
    Secondary
    End point timeframe
    From randomization until individual day of trial completion, up to 432 weeks
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3023 [7]
    3010 [8]
    Units: Incidence rate/ 1000 patients-years
        number (not applicable)
    23.4
    23.7
    Notes
    [7] - TS
    [8] - TS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the third step in a pre-defined hierarchical testing approach.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    6033
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.4334 [10]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95.47%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.14
    Notes
    [9] - Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.
    [10] - P-values derived from Wald´s Chi-square test.

    Secondary: Percentage of participants taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without >2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase

    		 Close Top of page
    End point title
    		 Percentage of participants taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without >2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase
    End point description
    The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without >2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase. TS without duplicates (TS w/o duplicates), patients who are off-drug or died prior to regular study stop were handled as non-completers considered failure (NCF).
    End point type
    Secondary
    End point timeframe
    From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3014 [11]
    3000 [12]
    Units: Percentage of participants (%)
        number (confidence interval 95%)
    16.0 (14.7 to 17.3)
    10.2 (9.1 to 11.3)
    Notes
    [11] - TS w/o duplicates (NCF)
    [12] - TS w/o duplicates (NCF)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    6014
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 < 0.0001 [14]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.68
    Confidence interval
         level
    		 95.47%
         sides
    2-sided
         lower limit
    		 1.43
         upper limit
    		 1.96
    Notes
    [13] - Odds ratio and confidence interval are based on logistic regression with factor for treatment.
    [14] - p−value derived from chi−square test.

    Secondary: Percentage of participants who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without >2% weight gain during maintenance phase

    		 Close Top of page
    End point title
    		 Percentage of participants who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without >2% weight gain during maintenance phase
    End point description
    The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without >2% weight gain during maintenance phase.
    End point type
    Secondary
    End point timeframe
    From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3014 [15]
    3000 [16]
    Units: Percentage of participants (%)
        number (confidence interval 95%)
    17.4 (16.1 to 18.8)
    14.1 (12.9 to 15.4)
    Notes
    [15] - TS w/o duplicates (NCF)
    [16] - TS w/o duplicates (NCF)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the fifth step in a pre-defined hierarchical testing approach.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    6014
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.0004 [18]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95.47%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 1.48
    Notes
    [17] - Odds ratio and confidence interval are based on logistic regression with factor for treatment.
    [18] - p−value derived from logistic regression.

    Secondary: Percentage of participants with the occurrence of at least one event of 3P-MACE

    		 Close Top of page
    End point title
    		 Percentage of participants with the occurrence of at least one event of 3P-MACE
    End point description
    Occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint.
    End point type
    Secondary
    End point timeframe
    From randomization until individual day of trial completion, up to 432 weeks
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3023 [19]
    3010 [20]
    Units: Percentage of participants (%)
        number (confidence interval 95%)
    11.8 (10.7 to 13.0)
    12.0 (10.9 to 13.2)
    Notes
    [19] - TS
    [20] - TS
    No statistical analyses for this end point

    Secondary: Percentage of participants with the occurrence of at least one event of 4P -MACE

    		 Close Top of page
    End point title
    		 Percentage of participants with the occurrence of at least one event of 4P -MACE
    End point description
    Occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint.
    End point type
    Secondary
    End point timeframe
    From randomization until individual day of trial completion, up to 432 weeks
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3023 [21]
    3010 [22]
    Units: Percentage of participants (%)
        number (confidence interval 95%)
    13.2 (12.0 to 14.4)
    13.3 (12.2 to 14.6)
    Notes
    [21] - TS
    [22] - TS
    No statistical analyses for this end point

    Secondary: Percentage of participants with occurrence of any of the components of the composite endpoint of all adjudication-confirmed events

    		 Close Top of page
    End point title
    		 Percentage of participants with occurrence of any of the components of the composite endpoint of all adjudication-confirmed events
    End point description
    Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of: - CV death (including fatal stroke and fatal MI) - non-fatal MI - non-fatal stroke - hospitalisation for unstable angina pectoris - TIA - hospitalisation for heart failure - hospitalisation for coronary revascularisation procedures (CABG, PCI)
    End point type
    Secondary
    End point timeframe
    From start of the treatment until 7 days after the end of treatment, up to 433 weeks
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3023 [23]
    3010 [24]
    Units: Percentage of participants (%)
        number (confidence interval 95%)
    17.1 (15.8 to 18.5)
    17.8 (16.4 to 19.2)
    Notes
    [23] - TS
    [24] - TS
    No statistical analyses for this end point

    Secondary: Time to first occurrence of any of the components of the composite endpoint of all adjudication-confirmed events

    		 Close Top of page
    End point title
    		 Time to first occurrence of any of the components of the composite endpoint of all adjudication-confirmed events
    End point description
    Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of: - CV death (including fatal stroke and fatal MI) - non-fatal MI - non-fatal stroke - hospitalisation for unstable angina pectoris - Transient ischaemic attack (TIA) - hospitalisation for heart failure - hospitalisation for coronary revascularisation procedures (CABG, PCI)
    End point type
    Secondary
    End point timeframe
    From start of the treatment until 7 days after the end of treatment, up to 433 weeks
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3023 [25]
    3010 [26]
    Units: Incidence rate/ 1000 patients-years
        number (not applicable)
    31.1
    32.4
    Notes
    [25] - TS
    [26] - TS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the fifth step in a pre-defined hierarchical testing approach.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    6033
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    P-value
    		 = 0.5249 [28]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.09
    Notes
    [27] - Hazard ratio and confidence interval derived from Cox regression with factor treatment.
    [28] - p−value derived from Wald´s chi−square test.

    Secondary: Change from baseline to final visit in hemoglobin A1c (HbA1c)

    		 Close Top of page
    End point title
    		 Change from baseline to final visit in hemoglobin A1c (HbA1c)
    End point description
    Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. TS_D observed cases - ALL (OC-ALL): All available data were considered, including values obtained on treatment and post-treatment. Missing data were not replaced. Any values taken after rescue medication intake were kept.
    End point type
    Secondary
    End point timeframe
    Baseline and week 432
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    2951 [29]
    2949 [30]
    Units: Percentage (%)
        least squares mean (standard error)
    0.06 ( 0.02 )
    0.15 ( 0.02 )
    Notes
    [29] - TS w/o duplicates considering all available data
    [30] - TS w/o duplicates considering all available data
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the fifth step in a pre-defined hierarchical testing approach. The Analysis of Covariance (ANCOVA) model includes the fixed categorical effect of treatment and the continuous covariate of baseline HbA1c.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    5900
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    P-value
    		 = 0.0023
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 -0.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.03
    Notes
    [31] - Mean difference = Linagliptin mean – Glimepiride mean

    Secondary: Change from baseline to final visit in fasting plasma glucose (FPG)

    		 Close Top of page
    End point title
    		 Change from baseline to final visit in fasting plasma glucose (FPG)
    End point description
    Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and week 432
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    2996 [32]
    2949 [33]
    Units: Milligram/ deciliter (mg/dL)
        least squares mean (standard error)
    12.4 ( 0.9 )
    19.7 ( 0.9 )
    Notes
    [32] - TS w/o duplicates considering all available data
    [33] - TS w/o duplicates considering all available data
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the fifth step in a pre-defined hierarchical testing approach. The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    5945
    Analysis specification
    Pre-specified
    Analysis type
    		 other [34]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.7
         upper limit
    		 -4.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [34] - Mean difference = Linagliptin mean – Glimepiride mean

    Secondary: Change from baseline to final visit fasting total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol

    		 Close Top of page
    End point title
    		 Change from baseline to final visit fasting total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol
    End point description
    Change from baseline to final visit in fasting total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. TS_D observed cases– rescue observed cases (OC-ROC): Only the available data that were observed while patients were on trial medication (defined as time from first drug intake until last permanent treatment stop date plus the endpoint specific follow-up time) were considered.
    End point type
    Secondary
    End point timeframe
    Baseline and week 432
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3014 [35]
    3000 [36]
    Units: mg/dL
    least squares mean (standard error)
        LDL cholesterol
    -6.1 ( 0.6 )
    -6.5 ( 0.6 )
        HDL cholesterol
    0.7 ( 0.2 )
    0.3 ( 0.2 )
        Total cholesterol
    -5.4 ( 0.7 )
    -0.5 ( 0.7 )
    Notes
    [35] - TS w/o duplicates, participants on treatment
    [36] - TS w/o duplicates, participants on treatment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    LDL cholesterol. This was the fifth step in a pre-defined hierarchical testing approach. The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline LDL cholesterol.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    6014
    Analysis specification
    Pre-specified
    Analysis type
    		 other [37]
    P-value
    		 = 0.64
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.4
    Confidence interval
         level
    		 95.47%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 2.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.9
    Notes
    [37] - Mean difference = Linagliptin mean – Glimepiride mean
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    HDL cholesterol. This was the fifth step in a pre-defined hierarchical testing approach. The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline HDL cholesterol.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    6014
    Analysis specification
    Pre-specified
    Analysis type
    		 other [38]
    P-value
    		 = 0.0497
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [38] - Mean difference = Linagliptin mean – Glimepiride mean
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Total cholesterol. This was the fifth step in a pre-defined hierarchical testing approach. The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline total cholesterol.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    6014
    Analysis specification
    Pre-specified
    Analysis type
    		 other [39]
    P-value
    		 = 0.6823
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1
    Notes
    [39] - Mean difference = Linagliptin mean – Glimepiride mean

    Secondary: Change from baseline to final visit in triglycerides

    		 Close Top of page
    End point title
    		 Change from baseline to final visit in triglycerides
    End point description
    Change from baseline to final visit in triglycerides is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and week 432
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    2788 [40]
    2762 [41]
    Units: mg/dL
        least squares mean (standard error)
    1.7 ( 2.2 )
    5.2 ( 2.2 )
    Notes
    [40] - TS w/o duplicates, participants on treatment
    [41] - TS w/o duplicates, participants on treatment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the fifth step in a pre-defined hierarchical testing approach. The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline triglycerides.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    5550
    Analysis specification
    Pre-specified
    Analysis type
    		 other [42]
    P-value
    		 = 0.2678
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.6
         upper limit
    		 2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.1
    Notes
    [42] - Mean difference = Linagliptin mean – Glimepiride mean

    Secondary: Change from baseline to final visit in creatinine

    		 Close Top of page
    End point title
    		 Change from baseline to final visit in creatinine
    End point description
    Change from baseline to final visit in creatinine is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and week 432
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    2917 [43]
    2898 [44]
    Units: mg/dL
        least squares mean (standard error)
    0.08 ( 0.01 )
    0.09 ( 0.01 )
    Notes
    [43] - TS w/o duplicates, participants on treatment
    [44] - TS w/o duplicates, participants on treatment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the fifth step in a pre-defined hierarchical testing approach. The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline creatinine.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    5815
    Analysis specification
    Pre-specified
    Analysis type
    		 other [45]
    P-value
    		 = 0.5165
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.01
    Notes
    [45] - Mean difference = Linagliptin mean – Glimepiride mean

    Secondary: Change from baseline to final visit in estimated glomerular filtration rate (eGFR)

    		 Close Top of page
    End point title
    		 Change from baseline to final visit in estimated glomerular filtration rate (eGFR)
    End point description
    Change from baseline to final visit in eGFR is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and week 432
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    2917 [46]
    2898 [47]
    Units: mL/minute/1.73 meter^2
        least squares mean (standard error)
    -4.0 ( 0.3 )
    -5.0 ( 0.3 )
    Notes
    [46] - TS w/o duplicates, participants on treatment
    [47] - TS w/o duplicates, participants on treatment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the fifth step in a pre-defined hierarchical testing approach. The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline eGFR.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    5815
    Analysis specification
    Pre-specified
    Analysis type
    		 other [48]
    P-value
    		 = 0.5165
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [48] - Mean difference = Linagliptin mean – Glimepiride mean

    Secondary: Change from baseline to final visit in urine albumin creatinine ratio (UACR)

    		 Close Top of page
    End point title
    		 Change from baseline to final visit in urine albumin creatinine ratio (UACR)
    End point description
    Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. Least square mean is adjusted gMean ratio. The Final Visit value referred to the last value obtained on-treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and week 432
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    2904 [49]
    2880 [50]
    Units: mg/ gcrea
        least squares mean (standard error)
    1.52 ( 1.83 )
    1.57 ( 1.83 )
    Notes
    [49] - TS w/o duplicates, participants on treatment
    [50] - TS w/o duplicates, participants on treatment
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    This was the fifth step in a pre-defined hierarchical testing approach. The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline UACR.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    5784
    Analysis specification
    Pre-specified
    Analysis type
    		 other [51]
    P-value
    		 = 0.2921
    Method
    		 ANCOVA
    Parameter type
    		 geometric mean (gMean) ratio (%)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.03
    Notes
    [51] - gMean ration= Linagliptin mean/ Glimepiride mean

    Secondary: Percentage of participants with transition in albuminuria classes

    		 Close Top of page
    End point title
    		 Percentage of participants with transition in albuminuria classes
    End point description
    Percentage of patients with transition in albuminuria classes is presented as secondary endpoint. Data for last value on treatment (LVOT) to baseline (base) is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and week 432
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    3014 [52]
    3000 [53]
    Units: Percentage of participants (%)
    number (not applicable)
        Base (<30mg/gcrea) LVOT (<30mg/gcrea
    58.4
    57.7
        Base(<30mg/gcrea)LVOT(>=30 to<=300mg/gcrea)
    14.1
    16.0
        Base (<30 mg/gcrea) LVOT (>300 mg/gcrea)
    1.4
    1.4
        Base (>=30 to <=300 mg/gcrea) LVOT(<30mg/gcrea)
    5.4
    5.1
        Base(>=30to<=300mg/gcrea)LVOT(>=30to<=300mg/gcrea)
    12.7
    12.1
        Base (>=30 to <=300 mg/gcrea) LVOT(>300 mg/gcrea)
    3.5
    3.7
        Base (>300 mg/gcrea) LVOT (<30 mg/gcrea)
    0.1
    0.3
        Base (>300 mg/gcrea) LVOT(>=30 to<=300mg/gcrea)
    0.8
    0.9
        Base (>300 mg/gcrea) LVOT(>300 mg/gcrea)
    3.4
    2.7
    Notes
    [52] - TS w/o duplicates, participants on treatment
    [53] - TS w/o duplicates, participants on treatment
    No statistical analyses for this end point

    Secondary: Change from baseline of insulin secretion rate (ISR) at fixed glucose concentration at 208 weeks

    		 Close Top of page
    End point title
    		 Change from baseline of insulin secretion rate (ISR) at fixed glucose concentration at 208 weeks
    End point description
    The endpoint change from baseline of ISR at fixed glucose concentration at 208 weeks as derived from a 3-hour meal tolerance test is Beta-cell function sub-study endpoint. Meal tolerance test(MTT) last observation carried forward(LOCF) set: Randomised and treated patients with one dose of study drug and signed the substudy Informed Consent with valid baseline and on-treatment MTT. If values taken after rescue medication intake will be set to missing, last observed ontreatment value was carry forwarded.
    End point type
    Secondary
    End point timeframe
    Baseline and week 208
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    40 [54]
    48 [55]
    Units: Picomol/ minute/meter^2 (pmol/min/m²)
        arithmetic mean (standard error)
    11.07 ( 15.07 )
    6.95 ( 13.76 )
    Notes
    [54] - MTT_LOCF
    [55] - MTT_LOCF
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The ANCOVA model includes the fixed categorical effects of treatment and the continuous covariate of baseline ISR.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 other [56]
    P-value
    		 = 0.8402
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    4.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.46
         upper limit
    		 44.71
    Notes
    [56] - Mean difference= Linagliptin mean- Glimepiride mean

    Secondary: Percentage of participants with occurrence of accelerated cognitive decline at end of follow-up

    		 Close Top of page
    End point title
    		 Percentage of participants with occurrence of accelerated cognitive decline at end of follow-up
    End point description
    Occurrence of accelerated cognitive decline based on RBI score at end of follow-up (a dichotomous outcome measure; presence or absence of accelerated cognitive decline) is Cognition sub-study endpoint. Full analysis set cognition(FAS-COG): Randomised and treated patients with one dose of study drug, baseline assessment (the z-scores, A&E or Minimental state examination(MMSE) can be calculated), years of formal education with baseline MMSE≥24 and at least one on-treatment assessment (of which at least one of the RBI scores can be calculated).
    End point type
    Secondary
    End point timeframe
    433 weeks
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    1618 [57]
    1545 [58]
    Units: Percentage of participants (%)
        number (confidence interval 95%)
    27.8 (25.6 to 30.0)
    27.6 (25.4 to 29.9)
    Notes
    [57] - FAS-COG
    [58] - FAS-COG
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Logistic regression model with terms for treatment as a fixed effect with Wald confidence Interval was used.
    Comparison groups
    Linagliptin v Glimepiride
    Number of subjects included in analysis
    3163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [59]
    P-value
    		 = 0.9112
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.18
    Notes
    [59] - Linagliptin vs. Glimepiride odds is presented.

    Secondary: Change from baseline in the inter-quartile range of diurnal glucose variability to end of study

    		 Close Top of page
    End point title
    		 Change from baseline in the inter-quartile range of diurnal glucose variability to end of study
    End point description
    The data for this endpoint of the continuous glucose monitoring sub-study was not collected and analyzed as this sub study was stopped due to low than expected recruitment rate and an increased discontinuation rate.
    End point type
    Secondary
    End point timeframe
    433 weeks
    End point values
    		 Linagliptin Glimepiride
    Number of subjects analysed
    0 [60]
    0 [61]
    Units: Percentage of participants (%)
    Notes
    [60] - The continuous glucose monitoring sub-study was stopped.
    [61] - The continuous glucose monitoring sub-study was stopped.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Linagliptin
    Reporting group description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.

    Reporting group title
    Glimepiride
    Reporting group description
    		 After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.

    Serious adverse events
    		 Linagliptin Glimepiride
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1403 / 3023 (46.41%)
    1448 / 3010 (48.11%)
         number of deaths (all causes)
    308
    336
         number of deaths resulting from adverse events
    5
    8
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute lymphocytic leukaemia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute promyelocytic leukaemia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma of appendix
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    8 / 3023 (0.26%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Adenocarcinoma pancreas
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Adenoma benign
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiosarcoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    39 / 3023 (1.29%)
    33 / 3010 (1.10%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 44
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basosquamous carcinoma of skin
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Bladder cancer
         subjects affected / exposed
    4 / 3023 (0.13%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder papilloma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    2 / 3023 (0.07%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma recurrent
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    5 / 3023 (0.17%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain neoplasm benign
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    12 / 3023 (0.40%)
    9 / 3010 (0.30%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer metastatic
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Breast cancer stage IV
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast neoplasm
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Carcinoid tumour pulmonary
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoma in situ of skin
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system lymphoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    12 / 3023 (0.40%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Colon cancer metastatic
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Colon neoplasm
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctival melanoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cutaneous lymphoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         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
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysplastic naevus
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enchondromatosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Ependymoma benign
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential thrombocythaemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric adenoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    6 / 3023 (0.20%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal melanoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal cancer
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemangioma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hairy cell leukaemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hodgkin's disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypopharyngeal neoplasm
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leiomyoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lentigo maligna
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lentigo maligna recurrent
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    4 / 3023 (0.13%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Lung adenocarcinoma stage I
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage II
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (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
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Lung carcinoma cell type unspecified stage III
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    10 / 3023 (0.33%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung squamous cell carcinoma stage III
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocytic leukaemia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant ascites
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    7 / 3023 (0.23%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant polyp
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mantle cell lymphoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Meningioma
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bladder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastases to liver
         subjects affected / exposed
    5 / 3023 (0.17%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Metastases to lung
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Metastases to lymph nodes
         subjects affected / exposed
    5 / 3023 (0.17%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastases to peritoneum
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastasis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic neoplasm
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Mucinous adenocarcinoma of appendix
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mycosis fungoides
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myxofibrosarcoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nasopharyngeal cancer
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm prostate
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm skin
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurofibroma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oral papilloma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian epithelial cancer
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic carcinoma
         subjects affected / exposed
    9 / 3023 (0.30%)
    9 / 3010 (0.30%)
         occurrences causally related to treatment / all
    2 / 9
    3 / 9
         deaths causally related to treatment / all
    2 / 7
    3 / 7
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranasal sinus and nasal cavity malignant neoplasm
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 3023 (0.03%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Plasmacytoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural sarcoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Porocarcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prolactin-producing pituitary tumour
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    28 / 3023 (0.93%)
    29 / 3010 (0.96%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 30
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage 0
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    2 / 3023 (0.07%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal cancer metastatic
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Refractory anaemia with ringed sideroblasts
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    3 / 3023 (0.10%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cell carcinoma
         subjects affected / exposed
    6 / 3023 (0.20%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal neoplasm
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sebaceous carcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin angiosarcoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin cancer
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (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
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Small intestine adenocarcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine carcinoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Soft tissue sarcoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    6 / 3023 (0.20%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    6 / 3023 (0.20%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    13 / 3023 (0.43%)
    16 / 3010 (0.53%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         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 hypopharynx
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         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 vulva
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thymoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour ulceration
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Uterine leiomyoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vipoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Waldenstrom's macroglobulinaemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    5 / 3023 (0.17%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Aortic arteriosclerosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic occlusion
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    3 / 3023 (0.10%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arteritis
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atherosclerotic plaque rupture
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    4 / 3023 (0.13%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    9 / 3023 (0.30%)
    17 / 3010 (0.56%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Embolism venous
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery embolism
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    4 / 3023 (0.13%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    12 / 3023 (0.40%)
    9 / 3010 (0.30%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    15 / 3023 (0.50%)
    21 / 3010 (0.70%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 26
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hypertensive emergency
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    5 / 3023 (0.17%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infarction
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intermittent claudication
         subjects affected / exposed
    1 / 3023 (0.03%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic limb pain
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    6 / 3023 (0.20%)
    12 / 3010 (0.40%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    10 / 3023 (0.33%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 3023 (0.00%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral vascular disorder
         subjects affected / exposed
    3 / 3023 (0.10%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac operation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colostomy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colostomy closure
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary arterial stent insertion
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator insertion
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    3 / 3023 (0.10%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve replacement
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic operation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder arthroplasty
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal decompression
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent placement
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroidectomy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral prostatectomy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         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
    Adhesion
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    3 / 3023 (0.10%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adverse drug reaction
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    7 / 3023 (0.23%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 7
    0 / 3
    Chest discomfort
         subjects affected / exposed
    3 / 3023 (0.10%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    50 / 3023 (1.65%)
    52 / 3010 (1.73%)
         occurrences causally related to treatment / all
    0 / 64
    0 / 59
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Condition aggravated
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Death
         subjects affected / exposed
    20 / 3023 (0.66%)
    20 / 3010 (0.66%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 20
         deaths causally related to treatment / all
    0 / 20
    0 / 20
    Discomfort
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise tolerance decreased
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    3 / 3023 (0.10%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hernia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site extravasation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site haematoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mass
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 6
    Non-cardiac chest pain
         subjects affected / exposed
    8 / 3023 (0.26%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puncture site haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    7 / 3023 (0.23%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retention cyst
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Sudden death
         subjects affected / exposed
    9 / 3023 (0.30%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 4
         deaths causally related to treatment / all
    0 / 9
    1 / 4
    Swelling
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to vaccine
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Loss of personal independence in daily activities
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sexual abuse
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenomyosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balanoposthitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    5 / 3023 (0.17%)
    19 / 3010 (0.63%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast pain
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital haemorrhage
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic prolapse
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic obstruction
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatism
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    4 / 3023 (0.13%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterovaginal prolapse
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    2 / 3023 (0.07%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvar dysplasia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    9 / 3023 (0.30%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Acute respiratory distress syndrome
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    8 / 3023 (0.26%)
    10 / 3010 (0.33%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Apnoea
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Asthma
         subjects affected / exposed
    5 / 3023 (0.17%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    23 / 3023 (0.76%)
    26 / 3010 (0.86%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 49
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragm muscle weakness
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic paralysis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    15 / 3023 (0.50%)
    22 / 3010 (0.73%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 25
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea at rest
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    5 / 3023 (0.17%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    7 / 3023 (0.23%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercapnia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Interstitial lung disease
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lung disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nasal polyps
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pickwickian syndrome
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    8 / 3023 (0.26%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    3 / 3023 (0.10%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Productive cough
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary artery thrombosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    6 / 3023 (0.20%)
    16 / 3010 (0.53%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 6
    Pulmonary fibrosis
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pulmonary hypertension
         subjects affected / exposed
    6 / 3023 (0.20%)
    11 / 3010 (0.37%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    5 / 3023 (0.17%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary toxicity
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    8 / 3023 (0.26%)
    14 / 3010 (0.47%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 16
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    Sleep apnoea syndrome
         subjects affected / exposed
    3 / 3023 (0.10%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Snoring
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheomalacia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agitated depression
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    4 / 3023 (0.13%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burnout syndrome
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Delirium
         subjects affected / exposed
    6 / 3023 (0.20%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium tremens
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    3 / 3023 (0.10%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encopresis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 3023 (0.03%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    2 / 3023 (0.07%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somatic symptom disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient psychosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device battery issue
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device defective
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device fastener issue
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device leakage
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device loosening
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    6 / 3023 (0.20%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    20 / 3023 (0.66%)
    16 / 3010 (0.53%)
         occurrences causally related to treatment / all
    0 / 20
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    9 / 3023 (0.30%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    20 / 3023 (0.66%)
    14 / 3010 (0.47%)
         occurrences causally related to treatment / all
    0 / 21
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestatic liver injury
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis alcoholic
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder necrosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    3 / 3023 (0.10%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic fibrosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic lesion
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic mass
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    6 / 3023 (0.20%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocholecystis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Portal vein thrombosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 3023 (0.20%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amylase increased
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiocardiogram
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level below therapeutic
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 3023 (0.20%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase MB increased
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    12 / 3023 (0.40%)
    11 / 3010 (0.37%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure decreased
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Body temperature increased
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac stress test abnormal
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Computerised tomogram head abnormal
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment depression
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ambulatory abnormal
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Full blood count decreased
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    7 / 3023 (0.23%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate decreased
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C virus test
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio decreased
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelocyte count increased
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Positron emission tomogram abnormal
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight increased
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaesthetic complication cardiac
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    6 / 3023 (0.20%)
    11 / 3010 (0.37%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial restenosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod sting
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder injury
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone fragmentation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain herniation
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve replacement complication
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery restenosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cartilage injury
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical burn
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctival laceration
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    4 / 3023 (0.13%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery reocclusion
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    5 / 3023 (0.17%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Crush injury
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye contusion
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    31 / 3023 (1.03%)
    44 / 3010 (1.46%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 44
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Femoral neck fracture
         subjects affected / exposed
    4 / 3023 (0.13%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    9 / 3023 (0.30%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture of penis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    5 / 3023 (0.17%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    7 / 3023 (0.23%)
    16 / 3010 (0.53%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impacted fracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated incisional hernia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation of wound
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury corneal
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    6 / 3023 (0.20%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    5 / 3023 (0.17%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 3023 (0.03%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    7 / 3023 (0.23%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    6 / 3023 (0.20%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoconiosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural inflammation
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural urine leak
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative renal failure
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpericardiotomy syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    2 / 3023 (0.07%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    5 / 3023 (0.17%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    13 / 3023 (0.43%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Scar
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt occlusion
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    8 / 3023 (0.26%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    2 / 3023 (0.07%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic injury
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    5 / 3023 (0.17%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    5 / 3023 (0.17%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    6 / 3023 (0.20%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant dysfunction
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic arthritis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral injury
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Adenomatous polyposis coli
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous malformation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choledochal cyst
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital cystic kidney disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal dystrophy
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Developmental hip dysplasia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exomphalos
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrous dysplasia of bone
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hereditary haemochromatosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ichthyosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricle outflow tract obstruction
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    3 / 3023 (0.10%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Porokeratosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stargardt's disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urachal abnormality
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    18 / 3023 (0.60%)
    12 / 3010 (0.40%)
         occurrences causally related to treatment / all
    1 / 21
    0 / 12
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    52 / 3023 (1.72%)
    56 / 3010 (1.86%)
         occurrences causally related to treatment / all
    3 / 60
    2 / 59
         deaths causally related to treatment / all
    1 / 10
    1 / 8
    Adams-Stokes syndrome
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    37 / 3023 (1.22%)
    40 / 3010 (1.33%)
         occurrences causally related to treatment / all
    2 / 41
    0 / 44
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    54 / 3023 (1.79%)
    65 / 3010 (2.16%)
         occurrences causally related to treatment / all
    1 / 69
    2 / 75
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    5 / 3023 (0.17%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    4 / 3023 (0.13%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    4 / 3023 (0.13%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    39 / 3023 (1.29%)
    48 / 3010 (1.59%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 55
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    23 / 3023 (0.76%)
    14 / 3010 (0.47%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    10 / 3023 (0.33%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    3 / 3023 (0.10%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    6 / 3023 (0.20%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac aneurysm
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    4 / 3023 (0.13%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 7
    Cardiac asthma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    58 / 3023 (1.92%)
    53 / 3010 (1.76%)
         occurrences causally related to treatment / all
    0 / 78
    0 / 72
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Cardiac failure acute
         subjects affected / exposed
    7 / 3023 (0.23%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Cardiac failure chronic
         subjects affected / exposed
    9 / 3023 (0.30%)
    12 / 3010 (0.40%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    37 / 3023 (1.22%)
    45 / 3010 (1.50%)
         occurrences causally related to treatment / all
    2 / 42
    0 / 57
         deaths causally related to treatment / all
    1 / 7
    0 / 4
    Cardiac perforation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    4 / 3023 (0.13%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Cardiogenic shock
         subjects affected / exposed
    2 / 3023 (0.07%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Cardiomegaly
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conduction disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    43 / 3023 (1.42%)
    42 / 3010 (1.40%)
         occurrences causally related to treatment / all
    0 / 48
    0 / 44
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    4 / 3023 (0.13%)
    12 / 3010 (0.40%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diastolic dysfunction
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    4 / 3023 (0.13%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular hypertrophy
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    2 / 3023 (0.07%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Long QT syndrome
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    49 / 3023 (1.62%)
    64 / 3010 (2.13%)
         occurrences causally related to treatment / all
    0 / 53
    1 / 70
         deaths causally related to treatment / all
    0 / 6
    0 / 12
    Myocardial ischaemia
         subjects affected / exposed
    14 / 3023 (0.46%)
    9 / 3010 (0.30%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Myocardial rupture
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Palpitations
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postinfarction angina
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary valve stenosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular dysfunction
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Silent myocardial infarction
         subjects affected / exposed
    5 / 3023 (0.17%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrhythmia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    4 / 3023 (0.13%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Supraventricular tachyarrhythmia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 3023 (0.03%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tachyarrhythmia
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    5 / 3023 (0.17%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyrotoxic cardiomyopathy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    4 / 3023 (0.13%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Ventricular hypokinesia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    1 / 13
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wolff-Parkinson-White syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (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
    Altered state of consciousness
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Aphasia
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia haematoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia haemorrhage
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia infarction
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basilar artery stenosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basilar artery thrombosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain oedema
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain stem stroke
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Carotid artery aneurysm
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    5 / 3023 (0.17%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    13 / 3023 (0.43%)
    10 / 3010 (0.33%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central pain syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Cerebral infarction
         subjects affected / exposed
    14 / 3023 (0.46%)
    13 / 3010 (0.43%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cerebral ischaemia
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    51 / 3023 (1.69%)
    61 / 3010 (2.03%)
         occurrences causally related to treatment / all
    0 / 51
    2 / 64
         deaths causally related to treatment / all
    0 / 6
    2 / 8
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coordination abnormal
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    13 / 3023 (0.43%)
    19 / 3010 (0.63%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 20
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    11 / 3023 (0.36%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    2 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drop attacks
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalomalacia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    4 / 3023 (0.13%)
    11 / 3010 (0.37%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Facial paresis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised non-convulsive epilepsy
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Haemorrhagic cerebral infarction
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    6 / 3023 (0.20%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Headache
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia homonymous
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    6 / 3023 (0.20%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive cerebrovascular disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IIIrd nerve paralysis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal carotid artery kinking
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial mass
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    22 / 3023 (0.73%)
    20 / 3010 (0.66%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 21
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Lacunar infarction
         subjects affected / exposed
    4 / 3023 (0.13%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental impairment
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mononeuritis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological symptom
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paralysis recurrent laryngeal nerve
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    5 / 3023 (0.17%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Quadriplegia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal migraine
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    7 / 3023 (0.23%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    6 / 3023 (0.20%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory disturbance
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitic myelopathy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    5 / 3023 (0.17%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Subdural hygroma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    17 / 3023 (0.56%)
    18 / 3010 (0.60%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic cerebral infarction
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    31 / 3023 (1.03%)
    33 / 3010 (1.10%)
         occurrences causally related to treatment / all
    1 / 32
    1 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tunnel vision
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery aneurysm
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    14 / 3023 (0.46%)
    18 / 3010 (0.60%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    6 / 3023 (0.20%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic diathesis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Increased tendency to bruise
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    5 / 3023 (0.17%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic haematoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic vein thrombosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aural polyp
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conductive deafness
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness
         subjects affected / exposed
    7 / 3023 (0.23%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness neurosensory
         subjects affected / exposed
    3 / 3023 (0.10%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness unilateral
         subjects affected / exposed
    0 / 3023 (0.00%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear canal stenosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inner ear disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (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
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mixed deafness
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    9 / 3023 (0.30%)
    12 / 3010 (0.40%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amaurosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amaurosis fugax
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angle closure glaucoma
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphakia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blepharitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness transient
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    16 / 3023 (0.53%)
    21 / 3010 (0.70%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chalazion
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Detachment of retinal pigment epithelium
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry age-related macular degeneration
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine ophthalmopathy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid rash
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    29 / 3023 (0.96%)
    31 / 3010 (1.03%)
         occurrences causally related to treatment / all
    0 / 29
    2 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iris neovascularisation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lens dislocation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    12 / 3023 (0.40%)
    11 / 3010 (0.37%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular fibrosis
         subjects affected / exposed
    5 / 3023 (0.17%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neovascular age-related macular degeneration
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panophthalmitis
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open angle glaucoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital swelling
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pterygium
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery embolism
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal degeneration
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    6 / 3023 (0.20%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcerative keratitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitic glaucoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous adhesions
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous degeneration
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous detachment
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal incarcerated hernia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    7 / 3023 (0.23%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal pain lower
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal tenderness
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendiceal mucocoele
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bezoar
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    6 / 3023 (0.20%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon dysplasia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    4 / 3023 (0.13%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental necrosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    5 / 3023 (0.17%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diverticulum intestinal
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal polyp
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    2 / 3023 (0.07%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Enteritis
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive duodenitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    4 / 3023 (0.13%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    6 / 3023 (0.20%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    16 / 3023 (0.53%)
    10 / 3010 (0.33%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 3023 (0.00%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    18 / 3023 (0.60%)
    14 / 3010 (0.47%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haematoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal mass
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    3 / 3023 (0.10%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jejunal perforation
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (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
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    6 / 3023 (0.20%)
    9 / 3010 (0.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip swelling
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lumbar hernia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant gastrointestinal obstruction
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    3 / 3023 (0.10%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nausea
         subjects affected / exposed
    1 / 3023 (0.03%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal fistula
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal obstruction
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic failure
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis
         subjects affected / exposed
    10 / 3023 (0.33%)
    11 / 3010 (0.37%)
         occurrences causally related to treatment / all
    7 / 11
    3 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    8 / 3023 (0.26%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    4 / 8
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    5 / 3023 (0.17%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis necrotising
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia oral
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer perforation
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal fibrosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland calculus
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland mass
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    5 / 3023 (0.17%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swollen tongue
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue oedema
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue ulceration
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    4 / 3023 (0.13%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    7 / 3023 (0.23%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 3023 (0.10%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    2 / 3023 (0.07%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermal cyst
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis bullous
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis exfoliative
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    4 / 3023 (0.13%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic neuropathic ulcer
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ulcer
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macule
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nail bed inflammation
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Night sweats
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prurigo
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus generalised
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    2 / 3023 (0.07%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash macular
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash vesicular
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin lesion
         subjects affected / exposed
    1 / 3023 (0.03%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin plaque
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    3 / 3023 (0.10%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Solar lentigo
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient acantholytic dermatosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical haematoma
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    47 / 3023 (1.55%)
    41 / 3010 (1.36%)
         occurrences causally related to treatment / all
    3 / 52
    0 / 45
         deaths causally related to treatment / all
    1 / 4
    0 / 1
    Anuria
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atonic urinary bladder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neck obstruction
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder outlet obstruction
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder perforation
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder prolapse
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    15 / 3023 (0.50%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 17
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Diabetic nephropathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis membranous
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    7 / 3023 (0.23%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    7 / 3023 (0.23%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertonic bladder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocyturia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower urinary tract symptoms
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    14 / 3023 (0.46%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive nephropathy
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prerenal failure
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery arteriosclerosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    20 / 3023 (0.66%)
    13 / 3010 (0.43%)
         occurrences causally related to treatment / all
    0 / 22
    1 / 13
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Renal impairment
         subjects affected / exposed
    8 / 3023 (0.26%)
    10 / 3010 (0.33%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal mass
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stag horn calculus
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteral disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteral polyp
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    5 / 3023 (0.17%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral meatus stenosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    13 / 3023 (0.43%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basedow's disease
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    3 / 3023 (0.10%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoparathyroidism
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 3023 (0.20%)
    9 / 3010 (0.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    6 / 3023 (0.20%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    6 / 3023 (0.20%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone atrophy
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facet joint syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    4 / 3023 (0.13%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin pain
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    8 / 3023 (0.26%)
    12 / 3010 (0.40%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb deformity
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    11 / 3023 (0.36%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    49 / 3023 (1.62%)
    63 / 3010 (2.09%)
         occurrences causally related to treatment / all
    0 / 55
    0 / 73
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteolysis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    3 / 3023 (0.10%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Periarthritis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    9 / 3023 (0.30%)
    13 / 3010 (0.43%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    4 / 3023 (0.13%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    7 / 3023 (0.23%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sjogren's syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    4 / 3023 (0.13%)
    12 / 3010 (0.40%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal ligament ossification
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    5 / 3023 (0.17%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (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
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess intestinal
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess jaw
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    3 / 3023 (0.10%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acarodermatitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Actinomycotic pulmonary infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute hepatitis C
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Administration site cellulitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendiceal abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    5 / 3023 (0.17%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 3023 (0.03%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Body tinea
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    15 / 3023 (0.50%)
    11 / 3010 (0.37%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida sepsis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    17 / 3023 (0.56%)
    18 / 3010 (0.60%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cellulitis staphylococcal
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic tonsillitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon gangrene
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Complicated appendicitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Creutzfeldt-Jakob disease
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cystitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis escherichia
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 3023 (0.00%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic foot infection
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    6 / 3023 (0.20%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    3 / 3023 (0.10%)
    11 / 3010 (0.37%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    External ear cellulitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder abscess
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    3 / 3023 (0.10%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer helicobacter
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    17 / 3023 (0.56%)
    17 / 3010 (0.56%)
         occurrences causally related to treatment / all
    1 / 17
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 3023 (0.03%)
    9 / 3010 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective spondylitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 3023 (0.07%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    2 / 3023 (0.07%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 3023 (0.13%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningoencephalitis viral
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Morganella infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nosocomial infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    8 / 3023 (0.26%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis fungal
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perichondritis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peritonsillar abscess
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    83 / 3023 (2.75%)
    83 / 3010 (2.76%)
         occurrences causally related to treatment / all
    0 / 94
    0 / 94
         deaths causally related to treatment / all
    0 / 9
    0 / 13
    Pneumonia bacterial
         subjects affected / exposed
    3 / 3023 (0.10%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia necrotising
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    3 / 3023 (0.10%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Purulence
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    8 / 3023 (0.26%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    4 / 3023 (0.13%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis fungal
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyonephrosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 3023 (0.07%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal abscess
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrub typhus
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    17 / 3023 (0.56%)
    24 / 3010 (0.80%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 24
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Septic arthritis streptococcal
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    6 / 3023 (0.20%)
    7 / 3010 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Sialoadenitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine gangrene
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Soft tissue infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 3023 (0.17%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteritis
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethritis
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    30 / 3023 (0.99%)
    31 / 3010 (1.03%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    7 / 3023 (0.23%)
    6 / 3010 (0.20%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Varicella
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 3023 (0.03%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval abscess
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 3023 (0.07%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    13 / 3023 (0.43%)
    10 / 3010 (0.33%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    3 / 3023 (0.10%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 3023 (0.07%)
    3 / 3010 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    2 / 3023 (0.07%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 3023 (0.07%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    6 / 3023 (0.20%)
    8 / 3010 (0.27%)
         occurrences causally related to treatment / all
    1 / 6
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    7 / 3023 (0.23%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 3023 (0.00%)
    2 / 3010 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochloraemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    3 / 3023 (0.10%)
    29 / 3010 (0.96%)
         occurrences causally related to treatment / all
    1 / 3
    18 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    6 / 3023 (0.20%)
    4 / 3010 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    1 / 3023 (0.03%)
    0 / 3010 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 3023 (0.03%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    4 / 3023 (0.13%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolic disorder
         subjects affected / exposed
    0 / 3023 (0.00%)
    1 / 3010 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 3023 (0.00%)
    5 / 3010 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Linagliptin Glimepiride
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2376 / 3023 (78.60%)
    2504 / 3010 (83.19%)
    Investigations
    Lipase increased
         subjects affected / exposed
    209 / 3023 (6.91%)
    154 / 3010 (5.12%)
         occurrences all number
    282
    207
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    151 / 3023 (5.00%)
    170 / 3010 (5.65%)
         occurrences all number
    185
    204
    Vascular disorders
    Hypertension
         subjects affected / exposed
    430 / 3023 (14.22%)
    452 / 3010 (15.02%)
         occurrences all number
    523
    551
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    283 / 3023 (9.36%)
    358 / 3010 (11.89%)
         occurrences all number
    350
    609
    Headache
         subjects affected / exposed
    268 / 3023 (8.87%)
    295 / 3010 (9.80%)
         occurrences all number
    369
    418
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    208 / 3023 (6.88%)
    178 / 3010 (5.91%)
         occurrences all number
    240
    204
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    118 / 3023 (3.90%)
    162 / 3010 (5.38%)
         occurrences all number
    143
    209
    Oedema peripheral
         subjects affected / exposed
    150 / 3023 (4.96%)
    194 / 3010 (6.45%)
         occurrences all number
    168
    233
    Eye disorders
    Cataract
         subjects affected / exposed
    219 / 3023 (7.24%)
    203 / 3010 (6.74%)
         occurrences all number
    270
    239
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    195 / 3023 (6.45%)
    173 / 3010 (5.75%)
         occurrences all number
    221
    189
    Diarrhoea
         subjects affected / exposed
    365 / 3023 (12.07%)
    324 / 3010 (10.76%)
         occurrences all number
    492
    412
    Nausea
         subjects affected / exposed
    157 / 3023 (5.19%)
    164 / 3010 (5.45%)
         occurrences all number
    197
    213
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    284 / 3023 (9.39%)
    290 / 3010 (9.63%)
         occurrences all number
    360
    364
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    310 / 3023 (10.25%)
    308 / 3010 (10.23%)
         occurrences all number
    393
    378
    Back pain
         subjects affected / exposed
    388 / 3023 (12.83%)
    368 / 3010 (12.23%)
         occurrences all number
    474
    463
    Musculoskeletal pain
         subjects affected / exposed
    150 / 3023 (4.96%)
    181 / 3010 (6.01%)
         occurrences all number
    167
    198
    Osteoarthritis
         subjects affected / exposed
    224 / 3023 (7.41%)
    261 / 3010 (8.67%)
         occurrences all number
    265
    315
    Pain in extremity
         subjects affected / exposed
    215 / 3023 (7.11%)
    224 / 3010 (7.44%)
         occurrences all number
    261
    279
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    315 / 3023 (10.42%)
    340 / 3010 (11.30%)
         occurrences all number
    489
    506
    Influenza
         subjects affected / exposed
    268 / 3023 (8.87%)
    243 / 3010 (8.07%)
         occurrences all number
    374
    318
    Nasopharyngitis
         subjects affected / exposed
    530 / 3023 (17.53%)
    517 / 3010 (17.18%)
         occurrences all number
    1032
    1035
    Upper respiratory tract infection
         subjects affected / exposed
    313 / 3023 (10.35%)
    319 / 3010 (10.60%)
         occurrences all number
    606
    637
    Urinary tract infection
         subjects affected / exposed
    318 / 3023 (10.52%)
    312 / 3010 (10.37%)
         occurrences all number
    498
    499
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    422 / 3023 (13.96%)
    483 / 3010 (16.05%)
         occurrences all number
    1066
    1182
    Hypoglycaemia
         subjects affected / exposed
    299 / 3023 (9.89%)
    1067 / 3010 (35.45%)
         occurrences all number
    1042
    6846

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jul 2011
    Cardiovascular outcome events (if serious adverse event (SAE)) were to be reported as SAE if occurred during screening/run-in phase; after randomisation, they were to be reported as outcome event. The definition of treatment sustainability was corrected. The incidence of particular AEs was defined as “other endpoint”. Text was updated to reflect the latest standardised definitions for endpoint events in CV trials.
    06 Mar 2012
    Amendment 2 excluded silent MI from the primary endpoint and made it a tertiary cardiovascular endpoint. The CI for the primary objective was corrected based on the alpha spending function. The definition of SAEs and the criteria for (S)AE reporting were updated.
    01 Aug 2012
    The time to the first occurrence of any of the adjudicated components of the 3P-MACE was defined as first key secondary endpoint instead of secondary endpoint; therefore the other key secondary endpoints moved down in the testing hierarchy. Any confirmatory hypothesis test was to be performed on the FAS. A description of sensitivity analyses of the first key secondary endpoint was added and sensitivity analyses for the second and third key secondary endpoints were clarified. It was clarified that if patients did not experience a primary endpoint event, they were considered censored at their last documented trial visit. If a patient died and had no primary outcome event, the patient was censored at the date of death. The minimum number of randomised patients of 6000 was changed into an estimated number of 6000 patients, and it was added that the 400 weeks treatment duration was an estimated duration, to clarify that the trial was event-driven. As a result, the number of patients to be screened was increased from 9000 to 10.000 patients. Adjudication of pancreatic events was introduced and an adjudication committee was set up. It was also added that all symptomatic hypoglycaemic events, all asymptomatic hypoglycaemic events with glucose levels less than 3.0 mmol/L, and all asymptomatic hypoglycaemic events considered an AE by the investigator were to be reported as AE It was also clarified that the DMC performed periodic safety reviews.
    23 Apr 2013
    (S)AE and adverse events of special interest (AESI) reporting was clarified to be in line with BI SOPs. The possibility to follow-up on vital status and outcome events after withdrawal of informed consent was added. Prior-antidiabetic treatment was added as a subgroup to the planned analyses.
    14 Sep 2015
    Pancreatic cancer was defined as an AESI. Definitions of AESIs were aligned to the project standard. The tertiary cardiovascular (CV) endpoint was clarified: Any new onset of a fatal AE and the time to death was determined instead of the onset to the first fatal event. The follow-up period was changed from 7 to 30 days.
    20 Apr 2016
    The testing hierarchy was revised following a request from the steering committee (SC). The primary endpoint was changed to time to 3P-MACE. The first key secondary endpoint was to be tested hierarchically with a superiority hypothesis and was changed to time to 4P-MACE. The alpha level was adjusted. A Bonferroni adjustment was to be applied after the first data monitoring committee (DMC) interim analysis for the 4P-MACE and the following analyses based on 3P-MACE. The SC clarified that there would be 2 interim analyses. A clarification was added that silent MI was not an adjudicated endpoint and therefore was to be listed separately from the adjudicated tertiary CV endpoints.

    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 Oct 25 04:41:42 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA