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    Clinical Trial Results:
    A long-term extension trial of the Phase III lipid-lowering trials to assess the effect of long-term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8)

    Summary
    EudraCT number
    		 2017-003092-55
    Trial protocol
    		 GB   CZ   DE   SE   DK   HU   NL  
    Global end of trial date
    13 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2024
    First version publication date
    06 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MDCO-PCS-17-05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03814187
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Novartis Pharmaceuticals: CKJX839A12306B
    Sponsors
    Sponsor organisation name
    NovartisPharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objectives were to evaluate: -The effect of inclisiran treatment on the proportion of subjects achieving the pre-specified LDL-C targets at the end of study (EOS) -The safety and tolerability profile of long-term use of inclisiran
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Apr 2019
    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
    Canada: 65
    Country: Number of subjects enrolled
    Czechia: 28
    Country: Number of subjects enrolled
    Denmark: 45
    Country: Number of subjects enrolled
    Germany: 106
    Country: Number of subjects enrolled
    Hungary: 88
    Country: Number of subjects enrolled
    Netherlands: 147
    Country: Number of subjects enrolled
    Poland: 588
    Country: Number of subjects enrolled
    South Africa: 275
    Country: Number of subjects enrolled
    Spain: 80
    Country: Number of subjects enrolled
    Sweden: 29
    Country: Number of subjects enrolled
    Ukraine: 101
    Country: Number of subjects enrolled
    United Kingdom: 380
    Country: Number of subjects enrolled
    United States: 1342
    Worldwide total number of subjects
    3274
    EEA total number of subjects
    1111
    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)
    1425
    From 65 to 84 years
    1830
    85 years and over
    19

    Subject disposition

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    Recruitment
    Recruitment details
    		 1513 patients were enrolled to "Phase III Inclisiran-Inclisiran" arm, but one patient discontinued before receiving the study drug, and therefore the number of patients starting on that arm is 1512.

    Pre-assignment
    Screening details
    		 Participants completed a qualifying Phase II lipid lowering trial [MDCO-PCS-16-01 (ORION-3)] or Phase III lipid-lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-04 (ORION-10), or MDCO-PCS-17-08 (ORION-11) ] meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase III Inclisiran-Inclisiran
    Arm description
    		 Subjects who received inclisiran (actual treatment) in studies ORION-9/ ORION-10/ORION-11
    Arm type
    		 Experimental

    Investigational medicinal product name
    Inclisiran
    Investigational medicinal product code
    KJX839
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Inclisiran sodium 300 mg (equivalent to284 mg inclisiran) administered as asingle subcutaneous (SC) dose every180 days from the last dose in previousfeeder study until the end of the study.

    Arm title
    		 Phase III Placebo-Inclisiran
    Arm description
    		 subjects who received placebo (actual treatment) in ORION-9/ORION-10/ORION-11
    Arm type
    		 Experimental

    Investigational medicinal product name
    Inclisiran
    Investigational medicinal product code
    KJX839
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Inclisiran sodium 300 mg (equivalent to284 mg inclisiran) administered as asingle subcutaneous (SC) dose every180 days from the last dose in previousfeeder study (since subjects in this armwere newly initiating inclisiran, theyreceived the first two doses 90 daysapart) until the end of the study.

    Arm title
    		 ORION-3 Rollover
    Arm description
    		 Subjects rolling over from ORION-3 Phase II study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Inclisiran
    Investigational medicinal product code
    KJX839
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Inclisiran sodium 300 mg (equivalent to284 mg inclisiran) administered as asingle subcutaneous (SC) dose every180 days from the last dose in previousfeeder study until the end of the study.

    Number of subjects in period 1
    		Phase III Inclisiran-Inclisiran Phase III Placebo-Inclisiran ORION-3 Rollover
    Started
    1512
    1478
    284
    Completed
    1246
    1200
    0
    Not completed
    266
    278
    284
         Adverse event, serious fatal
    80
    81
    4
         Withdrew Consent
    77
    78
    2
         Physician decision
    6
    4
    2
         Initiation Of Prohibited Approved PCSK9 Inhibitor
    -
    -
    1
         Adverse event, non-fatal
    22
    23
    -
         Other reasons
    34
    40
    2
         Lost to follow-up
    47
    52
    1
         Sponsor's Administrative Decision
    -
    -
    272

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase III Inclisiran-Inclisiran
    Reporting group description
    		 Subjects who received inclisiran (actual treatment) in studies ORION-9/ ORION-10/ORION-11

    Reporting group title
    Phase III Placebo-Inclisiran
    Reporting group description
    		 subjects who received placebo (actual treatment) in ORION-9/ORION-10/ORION-11

    Reporting group title
    ORION-3 Rollover
    Reporting group description
    		 Subjects rolling over from ORION-3 Phase II study

    Reporting group values
    		 Phase III Inclisiran-Inclisiran Phase III Placebo-Inclisiran ORION-3 Rollover Total
    Number of subjects
    		 1512 1478 284 3274
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 666 672 87 1425
        From 65-84 years
    		 838 798 194 1830
        85 years and over
    		 8 8 3 19
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.7 ( 9.83 ) 64.6 ( 9.82 ) 67.7 ( 9.97 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 482 476 100 1058
        Male
    		 1030 1002 184 2216
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian/Alaska Native
    		 3 2 2 7
        Asian
    		 17 7 3 27
        Black/African American
    		 103 78 7 188
        Native Hawaiian/Other Pacific Islander
    		 6 4 0 10
        White
    		 1383 1387 271 3041
        Missing
    		 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Phase III Inclisiran-Inclisiran
    Reporting group description
    		 Subjects who received inclisiran (actual treatment) in studies ORION-9/ ORION-10/ORION-11

    Reporting group title
    Phase III Placebo-Inclisiran
    Reporting group description
    		 subjects who received placebo (actual treatment) in ORION-9/ORION-10/ORION-11

    Reporting group title
    ORION-3 Rollover
    Reporting group description
    		 Subjects rolling over from ORION-3 Phase II study

    Subject analysis set title
    Total
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Total number of participants from the safety population with valid LDL-C measurements at Day 1080/EOS

    Subject analysis set title
    Total
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population consisted of all ORION-3 rollover subjects who signed the informed consent to Study ORION-8, and all ORION-9/ORION-10/ORION-11 rollover subjects with at least one study drug administration in Study ORION-8

    Primary: Proportion of subjects achieving global lipid targets for their level of ASCVD risk

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    End point title
    		 Proportion of subjects achieving global lipid targets for their level of ASCVD risk [1]
    End point description
    The primary objective of the study is to evaluate the effect of inclisiran treatment on the proportion of subjects achieving prespecified LDL-C targets at end of study (EOS). Target is <70 mg/dL for atherosclerotic cardiovascular disease (ASCVD) subjects and <100 mg/dL for ASCVD risk equivalent subjects. Risk equivalent subjects are defined as either type 2 diabetes, familial hypercholesterolemia or a 10-year risk of a cardiovascular event ≥20% as assessed by the Framingham Risk Score or equivalent; without a medical history of coronary heart disease , cerebrovascular disease or peripheral artery disease.
    End point type
    Primary
    End point timeframe
    From ORION-8 Day 1 to the end of study (up to 1080 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this primary outcome
    End point values
    		 Phase III Inclisiran-Inclisiran Phase III Placebo-Inclisiran ORION-3 Rollover Total
    Number of subjects analysed
    1251
    1204
    276
    2731
    Units: Percentage of participants
    number (confidence interval 95%)
        % with Global Lipid Targets (GLT)
    78.18 (75.8 to 80.4)
    79.07 (76.7 to 81.3)
    76.81 (71.4 to 81.6)
    78.43 (76.8 to 80.0)
        % of ASCVD with GLT of <70 mg/dL
    79.34 (76.8 to 81.7)
    79.96 (77.4 to 82.4)
    76.70 (70.0 to 82.5)
    79.41 (77.7 to 81.1)
        % of ASCVD risk equivalent with GLT of <100 mg/dL
    72.56 (66.1 to 78.3)
    74.88 (68.6 to 80.5)
    77.00 (67.7 to 84.7)
    74.33 (70.4 to 78.0)
    No statistical analyses for this end point

    Primary: Incidence of treatment-emergent adverse events (TEAEs)

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    End point title
    		 Incidence of treatment-emergent adverse events (TEAEs) [2]
    End point description
    Safety assessments include adverse events and serious adverse events until the end of study. End of study visit occured at least 90 days following the last inclisiran dose once a decision was made to end the study (either by the subject, investigator or sponsor). For subjects prematurely and permanently discontinued from study treatment, who were not willing to return within the 90 day timeframe, the EOS visit was scheduled as soon as possible, or if decision to discontinue and not return was made at a specific visit, this visit became the EOS visit.
    End point type
    Primary
    End point timeframe
    From ORION-8 Day 1 to the end of study (up to 1080 days)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this primary outcome
    End point values
    		 Phase III Inclisiran-Inclisiran Phase III Placebo-Inclisiran ORION-3 Rollover Total
    Number of subjects analysed
    1512
    1478
    284
    3274
    Units: participants
        Adverse events
    1197
    1170
    181
    2548
        SAEs
    464
    482
    43
    989
        Fatal SAEs
    80
    81
    4
    165
        Adverse events: Treatment-related
    133
    148
    16
    297
        SAEs: Treatment-related
    2
    2
    1
    5
        Fatal SAEs: Treatment-related
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage change in LDL-C from the initial feeder study baseline

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    End point title
    		 Percentage change in LDL-C from the initial feeder study baseline
    End point description
    Percentage change from baseline in low density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran on LDL-C levels.
    End point type
    Secondary
    End point timeframe
    Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)
    End point values
    		 Phase III Inclisiran-Inclisiran Phase III Placebo-Inclisiran ORION-3 Rollover
    Number of subjects analysed
    1512
    1478
    284
    Units: Percentage change in LDL-C
    arithmetic mean (confidence interval 95%)
        ORION-8 Baseline
    -50.02 (-51.3 to -48.8)
    3.10 (1.4 to 4.9)
    -48.22 (-51.2 to -45.2)
        Day 1080 / EOS
    -48.96 (-50.5 to -47.4)
    -49.69 (-51.3 to -48.0)
    -49.95 (-52.6 to -47.3)
    No statistical analyses for this end point

    Secondary: Absolute change from the initial feeder study baseline in total cholesterol, triglycerides and HDL-C

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    End point title
    		 Absolute change from the initial feeder study baseline in total cholesterol, triglycerides and HDL-C
    End point description
    Absolute change from baseline in total cholesterol, triglycerides and high density lipoprotein cholesterol (HDL-C) was calculated to evaluate the effect of inclisiran on other lipids and lipoproteins.
    End point type
    Secondary
    End point timeframe
    Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)
    End point values
    		 Phase III Inclisiran-Inclisiran Phase III Placebo-Inclisiran ORION-3 Rollover
    Number of subjects analysed
    1512
    1478
    284
    Units: mg/dL
    arithmetic mean (confidence interval 95%)
        ORION-8 Baseline Total Cholesterol (TC)
    -59.05 (-61.0 to -57.1)
    -0.07 (-2.2 to 2.1)
    -63.11 (-68.3 to -57.9)
        Day 1080 / EOS Total Cholesterol (TC)
    -58.48 (-61.0 to -55.9)
    -57.08 (-59.6 to -54.6)
    -65.43 (-70.5 to -60.3)
        ORION-8 Baseline Triglycerides
    -21.50 (-25.1 to -17.9)
    -5.74 (-9.5 to -2.0)
    -14.43 (-23.7 to -5.1)
        Day 1080 / EOS Triglycerides
    -19.58 (-23.7 to -15.4)
    -22.12 (-26.3 to -17.9)
    -21.32 (-30.3 to -12.4)
        ORION-8 Baseline HDL Cholesterol
    3.37 (2.9 to 3.9)
    0.59 (0.1 to 1.1)
    3.41 (2.2 to 4.6)
        Day 1080 / EOS HDL Cholesterol
    3.60 (3.0 to 4.2)
    4.39 (3.8 to 5.0)
    5.27 (3.8 to 6.7)
    No statistical analyses for this end point

    Secondary: Percentage change from the initial feeder study baseline in total cholesterol, triglycerides and HDL-C

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    End point title
    		 Percentage change from the initial feeder study baseline in total cholesterol, triglycerides and HDL-C
    End point description
    Percentage change from baseline in total cholesterol (TC), triglycerides and high density lipoprotein cholesterol (HDL-C) was calculated to evaluate the effect of inclisiran on other lipids and lipoproteins.
    End point type
    Secondary
    End point timeframe
    Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)
    End point values
    		 Phase III Inclisiran-Inclisiran Phase III Placebo-Inclisiran ORION-3 Rollover
    Number of subjects analysed
    1512
    1478
    284
    Units: Percentage change
    arithmetic mean (confidence interval 95%)
        ORION-8 Baseline Total Cholesterol (TC)
    -30.64 (-31.5 to -29.7)
    1.28 (0.1 to 2.4)
    -29.49 (-31.6 to -27.4)
        Day 1080 / EOS Total Cholesterol (TC)
    -29.34 (-30.5 to -28.2)
    -29.53 (-30.7 to -28.4)
    -30.44 (-32.4 to -28.5)
        ORION-8 Baseline Triglycerides
    -7.84 (-10.0 to -5.7)
    3.03 (0.8 to 5.2)
    -0.20 (-7.6 to 7.2)
        Day 1080 / EOS Triglycerides
    -3.90 (-6.5 to -1.3)
    -6.85 (-9.2 to -4.5)
    -3.18 (-9.2 to 2.8)
        ORION-8 Baseline HDL Cholesterol
    9.28 (8.2 to 10.4)
    3.48 (2.4 to 4.6)
    8.13 (5.7 to 10.5)
        Day 1080 / EOS HDL Cholesterol
    9.91 (8.7 to 11.2)
    11.75 (10.3 to 13.2)
    12.16 (9.3 to 15.0)
    No statistical analyses for this end point

    Secondary: Absolute change in LDL-C from the initial feeder study baseline

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    End point title
    		 Absolute change in LDL-C from the initial feeder study baseline
    End point description
    Absolute change from baseline in low density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran on LDL-C levels.
    End point type
    Secondary
    End point timeframe
    Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days)
    End point values
    		 Phase III Inclisiran-Inclisiran Phase III Placebo-Inclisiran ORION-3 Rollover
    Number of subjects analysed
    1512
    1478
    284
    Units: mg/dL
    arithmetic mean (confidence interval 95%)
        ORION-8 Baseline
    -55.21 (-56.9 to -53.5)
    0.46 (-1.4 to 2.3)
    -61.58 (-66.4 to -56.8)
        Day 1080 / EOS
    -55.81 (-58.0 to -53.6)
    -54.70 (-56.9 to -52.5)
    -64.31 (-69.0 to -59.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the start of study in ORION-8 until end of study treatment plus 90 days post treatment, up to a maximum duration of 1080 days.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator. Adverse Events are assessed in the safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Phase III Inclisiran-Inclisiran
    Reporting group description
    		 Phase III Inclisiran-Inclisiran

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    ORION-3 Rollover
    Reporting group description
    		 ORION-3 Rollover

    Reporting group title
    Phase III Placebo-Inclisiran
    Reporting group description
    		 Phase III Placebo-Inclisiran

    Serious adverse events
    		 Phase III Inclisiran-Inclisiran Total ORION-3 Rollover Phase III Placebo-Inclisiran
    Total subjects affected by serious adverse events
         subjects affected / exposed
    464 / 1512 (30.69%)
    989 / 3274 (30.21%)
    43 / 284 (15.14%)
    482 / 1478 (32.61%)
         number of deaths (all causes)
    80
    165
    4
    81
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign lung neoplasm
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaplastic thyroid cancer
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma metastatic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    5 / 1512 (0.33%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 16
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brenner tumour
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    2 / 1512 (0.13%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 16
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenoma
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal carcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    2 / 1512 (0.13%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 14
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Gastrointestinal neoplasm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal papilloma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lip and/or oral cavity cancer
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lip neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    3 / 1512 (0.20%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant mediastinal neoplasm
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant glioma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    7 / 1512 (0.46%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 22
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 1
    Lung neoplasm
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine carcinoma metastatic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm prostate
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic renal cell carcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma stage III
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal neoplasm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Oncocytoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Ovarian epithelial cancer
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    0 / 0
    0 / 1
    Ovarian adenoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Paraneoplastic syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    8 / 1512 (0.53%)
    15 / 3274 (0.46%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 32
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Small cell lung cancer metastatic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sarcoma uterus
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 12
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 14
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma metastatic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Triple negative breast cancer
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric cancer
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    5 / 1512 (0.33%)
    12 / 3274 (0.37%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 26
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Aortic occlusion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    3 / 1512 (0.20%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 18
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Granulomatosis with polyangiitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 12
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolism venous
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    4 / 1512 (0.26%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 14
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labile hypertension
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penetrating aortic ulcer
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    5 / 1512 (0.33%)
    13 / 3274 (0.40%)
    0 / 284 (0.00%)
    8 / 1478 (0.54%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 38
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leriche syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    6 / 1512 (0.40%)
    17 / 3274 (0.52%)
    3 / 284 (1.06%)
    8 / 1478 (0.54%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 38
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    12 / 1512 (0.79%)
    33 / 3274 (1.01%)
    2 / 284 (0.70%)
    19 / 1478 (1.29%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 66
    0 / 2
    0 / 19
         deaths causally related to treatment / all
    0 / 12
    0 / 33
    0 / 2
    0 / 19
    Exercise tolerance decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    10 / 1512 (0.66%)
    20 / 3274 (0.61%)
    0 / 284 (0.00%)
    10 / 1478 (0.68%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 42
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Organ failure
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immunisation reaction
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Perineal fistula
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    7 / 1512 (0.46%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 18
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast necrosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    9 / 1512 (0.60%)
    28 / 3274 (0.86%)
    2 / 284 (0.70%)
    17 / 1478 (1.15%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 62
    0 / 3
    0 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
    0 / 3
    Dyspnoea exertional
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    8 / 1512 (0.53%)
    17 / 3274 (0.52%)
    0 / 284 (0.00%)
    9 / 1478 (0.61%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 40
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    6 / 1512 (0.40%)
    16 / 3274 (0.49%)
    2 / 284 (0.70%)
    8 / 1478 (0.54%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 32
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    8 / 1512 (0.53%)
    14 / 3274 (0.43%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 30
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis aspiration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 12
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    Confusional state
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised anxiety disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conversion disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device loosening
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Troponin T increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial necrosis marker increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic restenosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 12
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    6 / 1512 (0.40%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heat stroke
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural hypotension
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomal hernia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular access site haematoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    17 / 1512 (1.12%)
    44 / 3274 (1.34%)
    3 / 284 (1.06%)
    24 / 1478 (1.62%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 104
    0 / 5
    0 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Angina pectoris
         subjects affected / exposed
    21 / 1512 (1.39%)
    43 / 3274 (1.31%)
    2 / 284 (0.70%)
    20 / 1478 (1.35%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 90
    0 / 2
    0 / 22
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    12 / 1512 (0.79%)
    32 / 3274 (0.98%)
    2 / 284 (0.70%)
    18 / 1478 (1.22%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 70
    0 / 2
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve calcification
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 12
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Arrhythmic storm
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    3 / 1512 (0.20%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 22
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    0 / 6
    0 / 0
    0 / 3
    Atrial flutter
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 12
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    17 / 1512 (1.12%)
    35 / 3274 (1.07%)
    3 / 284 (1.06%)
    15 / 1478 (1.01%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 80
    0 / 4
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    10 / 1512 (0.66%)
    26 / 3274 (0.79%)
    1 / 284 (0.35%)
    15 / 1478 (1.01%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 74
    0 / 1
    0 / 26
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    0 / 0
    0 / 3
    Cardiac failure acute
         subjects affected / exposed
    4 / 1512 (0.26%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 16
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 12
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    15 / 1512 (0.99%)
    29 / 3274 (0.89%)
    1 / 284 (0.35%)
    13 / 1478 (0.88%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 78
    0 / 1
    0 / 19
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 1
    Chronic coronary syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cardiomyopathy
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiorenal syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 2
    Chronic left ventricular failure
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    36 / 1512 (2.38%)
    64 / 3274 (1.95%)
    2 / 284 (0.70%)
    26 / 1478 (1.76%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 138
    0 / 2
    0 / 29
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    12 / 1512 (0.79%)
    33 / 3274 (1.01%)
    2 / 284 (0.70%)
    19 / 1478 (1.29%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 66
    0 / 2
    0 / 19
         deaths causally related to treatment / all
    0 / 4
    0 / 11
    0 / 1
    0 / 6
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 10
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diastolic dysfunction
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    7 / 1512 (0.46%)
    15 / 3274 (0.46%)
    0 / 284 (0.00%)
    8 / 1478 (0.54%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 32
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Nodal arrhythmia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular hypokinesia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    4 / 1512 (0.26%)
    10 / 3274 (0.31%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 22
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Basal ganglia haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bell's palsy
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    8 / 1512 (0.53%)
    14 / 3274 (0.43%)
    2 / 284 (0.70%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 30
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    Cerebellar haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical cord compression
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cortical laminar necrosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Intracranial mass
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    16 / 1512 (1.06%)
    26 / 3274 (0.79%)
    0 / 284 (0.00%)
    10 / 1478 (0.68%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 56
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    4 / 1512 (0.26%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paralysis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    11 / 1512 (0.73%)
    18 / 3274 (0.55%)
    1 / 284 (0.35%)
    6 / 1478 (0.41%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 38
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    5 / 1512 (0.33%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 26
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasogenic cerebral oedema
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 14
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Deficiency anaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 12
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear canal stenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniere's disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otosclerosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    6 / 1512 (0.40%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 16
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal fat apron
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    5 / 1512 (0.33%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenogastric reflux
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric fistula
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Gastric ulcer
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric volvulus
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal atony
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    5 / 1512 (0.33%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 22
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Intestinal polyp
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal dysplasia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal mucosal tear
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 10
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Pancreatitis chronic
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proctitis ulcerative
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pylorospasm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 12
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Salivary duct obstruction
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal ulcer haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Terminal ileitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 10
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    7 / 3274 (0.21%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 14
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatomegaly
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    6 / 1512 (0.40%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 18
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cirrhosis alcoholic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder rupture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic fibrosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    3 / 1512 (0.20%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 18
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reactive perforating collagenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ulcer
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    16 / 1512 (1.06%)
    29 / 3274 (0.89%)
    1 / 284 (0.35%)
    12 / 1478 (0.81%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 64
    0 / 1
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis chronic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    4 / 1512 (0.26%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 12
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurogenic bladder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 16
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Glomerulonephritis membranous
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism primary
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroiditis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    2 / 1512 (0.13%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 14
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma muscle
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    5 / 1512 (0.33%)
    9 / 3274 (0.27%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 22
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint instability
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    8 / 1512 (0.53%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 18
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    16 / 1512 (1.06%)
    36 / 3274 (1.10%)
    0 / 284 (0.00%)
    20 / 1478 (1.35%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 78
    0 / 0
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal synovial cyst
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    21 / 1512 (1.39%)
    49 / 3274 (1.50%)
    0 / 284 (0.00%)
    28 / 1478 (1.89%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 98
    0 / 0
    0 / 28
         deaths causally related to treatment / all
    0 / 5
    0 / 15
    0 / 0
    0 / 10
    Bacteraemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial colitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    14 / 1512 (0.93%)
    35 / 3274 (1.07%)
    0 / 284 (0.00%)
    21 / 1478 (1.42%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 72
    0 / 0
    0 / 21
         deaths causally related to treatment / all
    0 / 3
    0 / 8
    0 / 0
    0 / 5
    Cellulitis
         subjects affected / exposed
    7 / 1512 (0.46%)
    15 / 3274 (0.46%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 30
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterobacter pneumonia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Enterobacter infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster meningoencephalitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    16 / 1512 (1.06%)
    35 / 3274 (1.07%)
    2 / 284 (0.70%)
    17 / 1478 (1.15%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 80
    0 / 2
    0 / 20
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 2
    Neuroborreliosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 16
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 10
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 1512 (0.07%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 12
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    4 / 1512 (0.26%)
    15 / 3274 (0.46%)
    3 / 284 (1.06%)
    8 / 1478 (0.54%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 30
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal urinary tract infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    9 / 1512 (0.60%)
    14 / 3274 (0.43%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 30
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viraemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    4 / 1512 (0.26%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    4 / 1512 (0.26%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 14
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Phase III Inclisiran-Inclisiran Total ORION-3 Rollover Phase III Placebo-Inclisiran
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1110 / 1512 (73.41%)
    2352 / 3274 (71.84%)
    169 / 284 (59.51%)
    1073 / 1478 (72.60%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholesteatoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Acrochordon
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Adrenal adenoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    8
    1
    2
    Adrenal neoplasm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    B-cell lymphoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Basal cell carcinoma
         subjects affected / exposed
    24 / 1512 (1.59%)
    30 / 3274 (0.92%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences all number
    33
    78
    1
    5
    Benign bone neoplasm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Benign laryngeal neoplasm
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Benign neoplasm of skin
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Bladder cancer
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Bladder papilloma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Bowen's disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    4
    1
    0
    Breast cancer
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Breast cancer metastatic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Meningioma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Melanocytic naevus
         subjects affected / exposed
    5 / 1512 (0.33%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    5
    14
    0
    2
    Colorectal adenoma
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Dysplastic naevus
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Eye naevus
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Fibroma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Gastrointestinal tract adenoma
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Haemangioma
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Haemangioma of liver
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Haemangioma of skin
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Juvenile melanoma benign
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Leiomyoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Lipoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Lymphoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Mantle cell lymphoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Metastases to bone
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Renal cell carcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Oesophageal papilloma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Oral papilloma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pancreatic neoplasm
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Parathyroid tumour benign
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Phaeochromocytoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pituitary tumour
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pituitary tumour benign
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Prostate cancer
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    14
    0
    4
    Prostatic adenoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Renal cancer
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Metastases to liver
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Renal hamartoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Seborrhoeic keratosis
         subjects affected / exposed
    5 / 1512 (0.33%)
    12 / 3274 (0.37%)
    3 / 284 (1.06%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    24
    3
    4
    Skin cancer
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Skin papilloma
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Skin squamous cell carcinoma recurrent
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    8
    1
    3
    Thyroid adenoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Thyroid cancer
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Tumour pain
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Vulvovaginal warts
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Vascular disorders
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Aneurysm
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Angiodysplasia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Angiopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Aortic aneurysm
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    2
    16
    0
    6
    Aortic arteriosclerosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Hot flush
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    0
    8
    0
    4
    Aortic stenosis
         subjects affected / exposed
    6 / 1512 (0.40%)
    10 / 3274 (0.31%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    6
    20
    1
    3
    Arterial occlusive disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Arterial thrombosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Arteriosclerosis
         subjects affected / exposed
    8 / 1512 (0.53%)
    10 / 3274 (0.31%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    8
    20
    0
    2
    Arteritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood pressure fluctuation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood pressure inadequately controlled
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Circulatory collapse
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    6
    0
    3
    Cyanosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Deep vein thrombosis
         subjects affected / exposed
    5 / 1512 (0.33%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    6
    16
    0
    2
    Diastolic hypertension
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Essential hypertension
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Extravasation blood
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Flushing
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Haematoma
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    14
    1
    3
    Haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Aortic dilatation
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    10
    0
    3
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Peripheral artery occlusion
         subjects affected / exposed
    2 / 1512 (0.13%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    2
    14
    0
    5
    Peripheral ischaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Peripheral vascular disorder
         subjects affected / exposed
    5 / 1512 (0.33%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    5
    14
    0
    2
    Peripheral venous disease
         subjects affected / exposed
    6 / 1512 (0.40%)
    14 / 3274 (0.43%)
    0 / 284 (0.00%)
    8 / 1478 (0.54%)
         occurrences all number
    8
    34
    0
    9
    Hypertension
         subjects affected / exposed
    106 / 1512 (7.01%)
    225 / 3274 (6.87%)
    9 / 284 (3.17%)
    110 / 1478 (7.44%)
         occurrences all number
    112
    484
    9
    121
    Hypertensive crisis
         subjects affected / exposed
    3 / 1512 (0.20%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    10
    0
    2
    Hypertensive urgency
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Hypotension
         subjects affected / exposed
    21 / 1512 (1.39%)
    43 / 3274 (1.31%)
    1 / 284 (0.35%)
    21 / 1478 (1.42%)
         occurrences all number
    23
    100
    2
    25
    Iliac artery arteriosclerosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Iliac artery stenosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    6
    0
    2
    Intermittent claudication
         subjects affected / exposed
    0 / 1512 (0.00%)
    8 / 3274 (0.24%)
    3 / 284 (1.06%)
    5 / 1478 (0.34%)
         occurrences all number
    0
    16
    3
    5
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Lymphoedema
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    8
    1
    0
    Microangiopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Orthostatic hypertension
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    3
    16
    0
    5
    Peripheral arterial occlusive disease
         subjects affected / exposed
    11 / 1512 (0.73%)
    22 / 3274 (0.67%)
    1 / 284 (0.35%)
    10 / 1478 (0.68%)
         occurrences all number
    11
    46
    1
    11
    Peripheral coldness
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Phlebitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    White coat hypertension
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Phlebitis superficial
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    0
    2
    Post thrombotic syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Superficial vein prominence
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Superficial vein thrombosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Systolic hypertension
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Thrombophlebitis
         subjects affected / exposed
    3 / 1512 (0.20%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    10
    0
    2
    Thrombosed varicose vein
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Thrombosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Varicose vein
         subjects affected / exposed
    6 / 1512 (0.40%)
    15 / 3274 (0.46%)
    0 / 284 (0.00%)
    9 / 1478 (0.61%)
         occurrences all number
    6
    30
    0
    9
    Vasculitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Venous hypertension
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Phlebitis deep
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    10
    1
    3
    Application site rash
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Asthenia
         subjects affected / exposed
    12 / 1512 (0.79%)
    20 / 3274 (0.61%)
    0 / 284 (0.00%)
    8 / 1478 (0.54%)
         occurrences all number
    12
    40
    0
    8
    Calcinosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Chest discomfort
         subjects affected / exposed
    8 / 1512 (0.53%)
    16 / 3274 (0.49%)
    3 / 284 (1.06%)
    5 / 1478 (0.34%)
         occurrences all number
    8
    32
    3
    5
    Chest pain
         subjects affected / exposed
    16 / 1512 (1.06%)
    36 / 3274 (1.10%)
    5 / 284 (1.76%)
    15 / 1478 (1.01%)
         occurrences all number
    21
    82
    5
    15
    Chills
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    10
    0
    3
    Crepitations
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Injection site oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    8
    0
    4
    Drug intolerance
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Exercise tolerance decreased
         subjects affected / exposed
    6 / 1512 (0.40%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    6
    16
    0
    2
    Eye complication associated with device
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Facial pain
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Fatigue
         subjects affected / exposed
    27 / 1512 (1.79%)
    53 / 3274 (1.62%)
    4 / 284 (1.41%)
    22 / 1478 (1.49%)
         occurrences all number
    30
    114
    4
    23
    Feeling abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Gait disturbance
         subjects affected / exposed
    2 / 1512 (0.13%)
    7 / 3274 (0.21%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    2
    14
    1
    4
    Generalised oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hernia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Inflammation
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Influenza like illness
         subjects affected / exposed
    10 / 1512 (0.66%)
    17 / 3274 (0.52%)
    2 / 284 (0.70%)
    5 / 1478 (0.34%)
         occurrences all number
    12
    40
    2
    6
    Injection site bruising
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Injection site eczema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Injection site erythema
         subjects affected / exposed
    10 / 1512 (0.66%)
    24 / 3274 (0.73%)
    2 / 284 (0.70%)
    12 / 1478 (0.81%)
         occurrences all number
    22
    92
    5
    19
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    6
    0
    3
    Injection site induration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cyst
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Injection site pain
         subjects affected / exposed
    22 / 1512 (1.46%)
    39 / 3274 (1.19%)
    0 / 284 (0.00%)
    17 / 1478 (1.15%)
         occurrences all number
    28
    100
    0
    22
    Polyp
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    4
    1
    0
    Injection site pruritus
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    2
    12
    0
    4
    Injection site rash
         subjects affected / exposed
    9 / 1512 (0.60%)
    16 / 3274 (0.49%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    12
    42
    0
    9
    Injection site reaction
         subjects affected / exposed
    42 / 1512 (2.78%)
    93 / 3274 (2.84%)
    2 / 284 (0.70%)
    49 / 1478 (3.32%)
         occurrences all number
    94
    402
    4
    103
    Injection site vesicles
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Injury associated with device
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Malaise
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Mass
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    4
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Nodule
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    10 / 1512 (0.66%)
    22 / 3274 (0.67%)
    1 / 284 (0.35%)
    11 / 1478 (0.74%)
         occurrences all number
    11
    46
    1
    11
    Oedema
         subjects affected / exposed
    3 / 1512 (0.20%)
    9 / 3274 (0.27%)
    3 / 284 (1.06%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    18
    3
    3
    Oedema peripheral
         subjects affected / exposed
    29 / 1512 (1.92%)
    51 / 3274 (1.56%)
    2 / 284 (0.70%)
    20 / 1478 (1.35%)
         occurrences all number
    30
    108
    2
    22
    Pain
         subjects affected / exposed
    7 / 1512 (0.46%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences all number
    7
    26
    1
    5
    Peripheral swelling
         subjects affected / exposed
    13 / 1512 (0.86%)
    27 / 3274 (0.82%)
    0 / 284 (0.00%)
    14 / 1478 (0.95%)
         occurrences all number
    15
    58
    0
    14
    Physical deconditioning
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Injection site paraesthesia
         subjects affected / exposed
    1 / 1512 (0.07%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    1
    14
    0
    6
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Swelling face
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Pyrexia
         subjects affected / exposed
    8 / 1512 (0.53%)
    21 / 3274 (0.64%)
    0 / 284 (0.00%)
    13 / 1478 (0.88%)
         occurrences all number
    11
    52
    0
    15
    Sensation of foreign body
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Contrast media allergy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    20
    4
    3
    Dust allergy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Food allergy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    8
    0
    4
    Immunisation reaction
         subjects affected / exposed
    5 / 1512 (0.33%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    6
    30
    2
    7
    Sarcoidosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Seasonal allergy
         subjects affected / exposed
    9 / 1512 (0.60%)
    26 / 3274 (0.79%)
    1 / 284 (0.35%)
    16 / 1478 (1.08%)
         occurrences all number
    9
    52
    1
    16
    Social circumstances
    Family stress
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    8
    1
    3
    Acquired phimosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Atrophic vulvovaginitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Benign prostatic hyperplasia
         subjects affected / exposed
    26 / 1512 (1.72%)
    48 / 3274 (1.47%)
    2 / 284 (0.70%)
    20 / 1478 (1.35%)
         occurrences all number
    26
    96
    2
    20
    Breast disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Breast mass
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Breast necrosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Erectile dysfunction
         subjects affected / exposed
    11 / 1512 (0.73%)
    21 / 3274 (0.64%)
    2 / 284 (0.70%)
    8 / 1478 (0.54%)
         occurrences all number
    11
    42
    2
    8
    Genital prolapse
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Prostatic mass
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Prostatitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    9 / 3274 (0.27%)
    1 / 284 (0.35%)
    6 / 1478 (0.41%)
         occurrences all number
    2
    18
    1
    6
    Prostatomegaly
         subjects affected / exposed
    6 / 1512 (0.40%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    6
    24
    0
    6
    Rectocele
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Scrotal oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Scrotal pain
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Sexual dysfunction
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Spermatocele
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Menopausal symptoms
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Nipple exudate bloody
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Ovarian calcification
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Ovarian mass
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pelvic pain
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Penile discharge
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Peyronie's disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Prostatism
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Testicular hypertrophy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Testicular pain
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Uterine prolapse
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vaginal discharge
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vaginal prolapse
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Vulva cyst
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    6
    1
    0
    Vulvovaginal dryness
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vulvovaginal inflammation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Testicular mass
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    1
    10
    0
    4
    Acquired diaphragmatic eventration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Acute respiratory failure
         subjects affected / exposed
    1 / 1512 (0.07%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    1
    12
    1
    4
    Allergic sinusitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Aspiration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Asthma
         subjects affected / exposed
    10 / 1512 (0.66%)
    17 / 3274 (0.52%)
    2 / 284 (0.70%)
    5 / 1478 (0.34%)
         occurrences all number
    14
    48
    4
    6
    Asthma exercise induced
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bronchiectasis
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Bronchospasm
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    13 / 1512 (0.86%)
    39 / 3274 (1.19%)
    2 / 284 (0.70%)
    24 / 1478 (1.62%)
         occurrences all number
    16
    92
    2
    28
    Cough
         subjects affected / exposed
    36 / 1512 (2.38%)
    71 / 3274 (2.17%)
    3 / 284 (1.06%)
    32 / 1478 (2.17%)
         occurrences all number
    39
    148
    3
    32
    Diaphragmatic disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Dry throat
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Dysphonia
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Dyspnoea
         subjects affected / exposed
    39 / 1512 (2.58%)
    76 / 3274 (2.32%)
    6 / 284 (2.11%)
    31 / 1478 (2.10%)
         occurrences all number
    40
    160
    6
    34
    Dyspnoea exertional
         subjects affected / exposed
    11 / 1512 (0.73%)
    23 / 3274 (0.70%)
    3 / 284 (1.06%)
    9 / 1478 (0.61%)
         occurrences all number
    12
    48
    3
    9
    Emphysema
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Epiglottic oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Epistaxis
         subjects affected / exposed
    10 / 1512 (0.66%)
    16 / 3274 (0.49%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    10
    32
    0
    6
    Haemoptysis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Hiccups
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hypoxia
         subjects affected / exposed
    4 / 1512 (0.26%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    4
    8
    0
    0
    Bronchial secretion retention
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pneumothorax
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Pleuritic pain
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Laryngeal ulceration
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Lung infiltration
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Lung opacity
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Nasal congestion
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Nasal mucosal blistering
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Nasal polyps
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Nasal septum deviation
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Obstructive airways disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    6 / 1512 (0.40%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    6 / 1478 (0.41%)
         occurrences all number
    7
    28
    1
    6
    Paranasal cyst
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Paranasal sinus discomfort
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Paranasal sinus inflammation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pleural effusion
         subjects affected / exposed
    5 / 1512 (0.33%)
    18 / 3274 (0.55%)
    1 / 284 (0.35%)
    12 / 1478 (0.81%)
         occurrences all number
    5
    36
    1
    12
    Pleural thickening
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Pleurisy
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Interstitial lung disease
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Productive cough
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    14
    0
    4
    Pulmonary calcification
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pulmonary congestion
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Pulmonary embolism
         subjects affected / exposed
    5 / 1512 (0.33%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    5
    12
    0
    1
    Pulmonary fibrosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Pulmonary hypertension
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Pulmonary mass
         subjects affected / exposed
    7 / 1512 (0.46%)
    13 / 3274 (0.40%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    7
    26
    0
    6
    Pulmonary oedema
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    10
    0
    2
    Rales
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Reflux laryngitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Respiratory acidosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Respiratory disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Respiratory failure
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    5 / 1512 (0.33%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    5
    22
    0
    6
    Rhinorrhoea
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    10
    0
    3
    Sinus congestion
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    14
    0
    4
    Sinus disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Sinus polyp
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    3
    16
    0
    5
    Sneezing
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Throat tightness
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    16
    1
    4
    Vocal cord cyst
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Wheezing
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Throat irritation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Psychiatric disorders
    Bipolar II disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Abnormal behaviour
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Abnormal dreams
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Acute stress disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    6
    0
    3
    Agitation
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Alcohol abuse
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Alcoholism
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Anxiety
         subjects affected / exposed
    16 / 1512 (1.06%)
    38 / 3274 (1.16%)
    1 / 284 (0.35%)
    21 / 1478 (1.42%)
         occurrences all number
    16
    76
    1
    21
    Anxiety disorder
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Bipolar disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Obsessive-compulsive disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Delirium
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Delusion
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Depressed mood
         subjects affected / exposed
    5 / 1512 (0.33%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    18
    0
    4
    Depression
         subjects affected / exposed
    29 / 1512 (1.92%)
    51 / 3274 (1.56%)
    3 / 284 (1.06%)
    19 / 1478 (1.29%)
         occurrences all number
    30
    104
    3
    19
    Grief reaction
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Habit cough
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hallucination
         subjects affected / exposed
    4 / 1512 (0.26%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    5
    10
    0
    0
    Hallucination, visual
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    6
    0
    3
    Initial insomnia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Insomnia
         subjects affected / exposed
    13 / 1512 (0.86%)
    28 / 3274 (0.86%)
    0 / 284 (0.00%)
    15 / 1478 (1.01%)
         occurrences all number
    13
    56
    0
    15
    Irritability
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Libido decreased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Loss of libido
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Mental status changes
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Nightmare
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Confusional state
         subjects affected / exposed
    6 / 1512 (0.40%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    7
    16
    0
    1
    Panic attack
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Restlessness
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Schizoaffective disorder bipolar type
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Sleep disorder
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    3
    16
    0
    5
    Stress
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Suicidal ideation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Product issues
    Device dislocation
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Device malfunction
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Device physical property issue
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Biliary colic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Biliary dilatation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cholecystitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Cholecystitis acute
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cholecystitis chronic
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Cholelithiasis
         subjects affected / exposed
    11 / 1512 (0.73%)
    28 / 3274 (0.86%)
    1 / 284 (0.35%)
    16 / 1478 (1.08%)
         occurrences all number
    11
    56
    1
    16
    Gallbladder polyp
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    6
    0
    3
    Hepatic calcification
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Hepatic cyst
         subjects affected / exposed
    0 / 1512 (0.00%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    0
    12
    0
    6
    Hepatic fibrosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Hepatic haematoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hepatic lesion
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Hepatomegaly
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    14
    0
    4
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Liver injury
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Non-alcoholic fatty liver
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    8
    1
    2
    Hepatic steatosis
         subjects affected / exposed
    17 / 1512 (1.12%)
    38 / 3274 (1.16%)
    4 / 284 (1.41%)
    17 / 1478 (1.15%)
         occurrences all number
    17
    76
    4
    17
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 1512 (0.40%)
    11 / 3274 (0.34%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    6
    24
    1
    5
    Aortic bruit
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Arteriogram coronary normal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 1512 (0.20%)
    9 / 3274 (0.27%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences all number
    4
    24
    1
    7
    Bilirubin conjugated increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    7 / 1512 (0.46%)
    12 / 3274 (0.37%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    7
    24
    0
    5
    Blood bilirubin increased
         subjects affected / exposed
    6 / 1512 (0.40%)
    14 / 3274 (0.43%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    7
    30
    1
    7
    Blood bilirubin unconjugated increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood calcium decreased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Blood calcium increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Antiphospholipid antibodies
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood sodium decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Blood creatine phosphokinase increased
         subjects affected / exposed
    27 / 1512 (1.79%)
    58 / 3274 (1.77%)
    0 / 284 (0.00%)
    31 / 1478 (2.10%)
         occurrences all number
    29
    124
    0
    33
    Blood creatinine increased
         subjects affected / exposed
    8 / 1512 (0.53%)
    15 / 3274 (0.46%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    8
    30
    0
    7
    Blood folate decreased
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    2
    12
    0
    4
    Blood glucose abnormal
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    3 / 284 (1.06%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    10
    3
    1
    Blood homocysteine increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood iron decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Blood lactic acid increased
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Blood potassium increased
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    8
    1
    1
    Blood pressure ambulatory increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood pressure decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood pressure diastolic decreased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Blood pressure increased
         subjects affected / exposed
    13 / 1512 (0.86%)
    27 / 3274 (0.82%)
    0 / 284 (0.00%)
    14 / 1478 (0.95%)
         occurrences all number
    13
    58
    0
    16
    Blood pressure systolic increased
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Blood creatine abnormal
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood sodium increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    4 / 1512 (0.26%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    8 / 1478 (0.54%)
         occurrences all number
    4
    28
    1
    9
    Blood urea increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Blood urine present
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Body temperature abnormal
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Borrelia test positive
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Brain natriuretic peptide increased
         subjects affected / exposed
    3 / 1512 (0.20%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    10
    0
    2
    C-reactive protein increased
         subjects affected / exposed
    8 / 1512 (0.53%)
    17 / 3274 (0.52%)
    2 / 284 (0.70%)
    7 / 1478 (0.47%)
         occurrences all number
    8
    34
    2
    7
    Carbohydrate antigen 15-3 increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cardiac murmur
         subjects affected / exposed
    5 / 1512 (0.33%)
    10 / 3274 (0.31%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    5
    20
    0
    5
    Cardiac stress test abnormal
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Carotid bruit
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Coronavirus test positive
         subjects affected / exposed
    1 / 1512 (0.07%)
    8 / 3274 (0.24%)
    3 / 284 (1.06%)
    4 / 1478 (0.27%)
         occurrences all number
    1
    16
    3
    4
    Ejection fraction decreased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Blood testosterone decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Hepatic enzyme abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Helicobacter test positive
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Electrocardiogram ST-T change
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    10
    0
    1
    Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Fibrin D dimer increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Gamma-glutamyltransferase abnormal
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    16 / 1512 (1.06%)
    39 / 3274 (1.19%)
    0 / 284 (0.00%)
    23 / 1478 (1.56%)
         occurrences all number
    20
    88
    0
    24
    Glomerular filtration rate decreased
         subjects affected / exposed
    9 / 1512 (0.60%)
    18 / 3274 (0.55%)
    1 / 284 (0.35%)
    8 / 1478 (0.54%)
         occurrences all number
    9
    36
    1
    8
    Glucose urine present
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    13 / 1512 (0.86%)
    29 / 3274 (0.89%)
    1 / 284 (0.35%)
    15 / 1478 (1.01%)
         occurrences all number
    13
    58
    1
    15
    Haematology test abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    12
    1
    2
    Haemoglobin increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Heart rate decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Heart rate irregular
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    10
    0
    3
    Hepatic enzyme increased
         subjects affected / exposed
    9 / 1512 (0.60%)
    17 / 3274 (0.52%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    9
    34
    1
    7
    Immunoglobulins decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Immunoglobulins increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    International normalised ratio increased
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Intraocular pressure increased
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Laboratory test abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Lipase increased
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Lipids increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Lipoprotein (a) increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Lipoprotein increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    7 / 3274 (0.21%)
    1 / 284 (0.35%)
    6 / 1478 (0.41%)
         occurrences all number
    0
    14
    1
    6
    Liver function test increased
         subjects affected / exposed
    2 / 1512 (0.13%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    2
    18
    0
    7
    Low density lipoprotein increased
         subjects affected / exposed
    5 / 1512 (0.33%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    5
    16
    0
    3
    Mean cell volume increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Monofilament pressure perception test abnormal
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Nitrite urine
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Occult blood positive
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Thyroxine increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Vitamin D decreased
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Serum ferritin decreased
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Scan myocardial perfusion abnormal
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    8
    1
    2
    Romberg test positive
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Respiratory rate increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Protein urine present
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Prostatic specific antigen increased
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Troponin increased
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    3
    16
    0
    5
    Tryptase increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Ultrasound Doppler abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Ultrasound scan abnormal
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Urinary system x-ray abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Urine analysis abnormal
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Urine output decreased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Serum ferritin increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    White blood cells urine positive
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Weight increased
         subjects affected / exposed
    4 / 1512 (0.26%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    4
    12
    0
    2
    Weight decreased
         subjects affected / exposed
    12 / 1512 (0.79%)
    19 / 3274 (0.58%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    12
    38
    0
    7
    Injury, poisoning and procedural complications
    Back injury
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Accident
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Administration related reaction
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Alcohol poisoning
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Anaemia postoperative
         subjects affected / exposed
    3 / 1512 (0.20%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    12
    0
    3
    Animal bite
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Animal scratch
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Ankle fracture
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    14
    0
    4
    Arterial injury
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Arthropod bite
         subjects affected / exposed
    5 / 1512 (0.33%)
    14 / 3274 (0.43%)
    1 / 284 (0.35%)
    8 / 1478 (0.54%)
         occurrences all number
    5
    28
    1
    8
    Arthropod sting
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Avulsion fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bone contusion
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Facial bones fracture
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    10
    0
    3
    Burns first degree
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cartilage injury
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Chest injury
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Clavicle fracture
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    10
    1
    2
    Comminuted fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Complications of transplanted lung
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Concussion
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Contusion
         subjects affected / exposed
    15 / 1512 (0.99%)
    38 / 3274 (1.16%)
    2 / 284 (0.70%)
    21 / 1478 (1.42%)
         occurrences all number
    17
    84
    3
    22
    Corneal abrasion
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Costochondral separation
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Ear injury
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Electric shock
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Epicondylitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    10
    1
    1
    Eye contusion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Eye injury
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    4
    1
    0
    Face injury
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Brain contusion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Fall
         subjects affected / exposed
    33 / 1512 (2.18%)
    81 / 3274 (2.47%)
    6 / 284 (2.11%)
    42 / 1478 (2.84%)
         occurrences all number
    45
    204
    6
    51
    Jaw fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Fibula fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Foot fracture
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    16
    1
    4
    Forearm fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Foreign body
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Foreign body in ear
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Foreign body in eye
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Fractured sacrum
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Hand fracture
         subjects affected / exposed
    8 / 1512 (0.53%)
    12 / 3274 (0.37%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    8
    24
    1
    3
    Head injury
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    10
    0
    1
    Heat exhaustion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Humerus fracture
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Incisional hernia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Injection related reaction
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    10
    0
    1
    Injury
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Intra-ocular injection complication
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Femur fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Joint dislocation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pelvic fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Ligament rupture
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    6
    1
    2
    Ligament sprain
         subjects affected / exposed
    8 / 1512 (0.53%)
    15 / 3274 (0.46%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    8
    32
    0
    8
    Limb crushing injury
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Limb fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Limb injury
         subjects affected / exposed
    10 / 1512 (0.66%)
    26 / 3274 (0.79%)
    1 / 284 (0.35%)
    15 / 1478 (1.01%)
         occurrences all number
    10
    58
    1
    18
    Limb traumatic amputation
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Lower limb fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Meniscus injury
         subjects affected / exposed
    5 / 1512 (0.33%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    5
    14
    0
    2
    Multiple injuries
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Muscle injury
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Muscle rupture
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    6
    1
    1
    Muscle strain
         subjects affected / exposed
    7 / 1512 (0.46%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    7
    22
    0
    4
    Musculoskeletal foreign body
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Neck injury
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Patella fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Joint injury
         subjects affected / exposed
    4 / 1512 (0.26%)
    12 / 3274 (0.37%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    4
    24
    1
    7
    Peripancreatic fluid collection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Rib fracture
         subjects affected / exposed
    8 / 1512 (0.53%)
    17 / 3274 (0.52%)
    1 / 284 (0.35%)
    8 / 1478 (0.54%)
         occurrences all number
    8
    34
    1
    8
    Post procedural constipation
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    6
    0
    3
    Post procedural hypothyroidism
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Post procedural inflammation
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Post vaccination syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Post-traumatic pain
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Postoperative thoracic procedure complication
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Postoperative wound complication
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Procedural complication
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Procedural headache
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Procedural nausea
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Procedural pain
         subjects affected / exposed
    4 / 1512 (0.26%)
    17 / 3274 (0.52%)
    3 / 284 (1.06%)
    10 / 1478 (0.68%)
         occurrences all number
    5
    38
    3
    11
    Radiation injury
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Radiation proctitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Radius fracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    0
    8
    0
    4
    Post procedural complication
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Road traffic accident
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    10
    1
    2
    Traumatic arthrosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Skin injury
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Skin laceration
         subjects affected / exposed
    18 / 1512 (1.19%)
    31 / 3274 (0.95%)
    2 / 284 (0.70%)
    11 / 1478 (0.74%)
         occurrences all number
    19
    64
    2
    11
    Skull fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Soft tissue injury
         subjects affected / exposed
    6 / 1512 (0.40%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    6
    18
    0
    3
    Spinal compression fracture
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    3
    16
    0
    5
    Spinal fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Splinter
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Subdural haematoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Synovial rupture
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Tendon injury
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Tendon rupture
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    12
    2
    2
    Thermal burn
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    4
    10
    1
    0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Tibia fracture
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    6
    1
    0
    Tobacco poisoning
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Tooth fracture
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    12
    1
    3
    Skin abrasion
         subjects affected / exposed
    7 / 1512 (0.46%)
    12 / 3274 (0.37%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    7
    24
    0
    5
    Wrist fracture
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    10
    0
    1
    Ulna fracture
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Upper limb fracture
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Vaccination complication
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Wound
         subjects affected / exposed
    5 / 1512 (0.33%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    5
    14
    0
    2
    Wound dehiscence
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Wound haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Wound necrosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Congenital, familial and genetic disorders
    Genetic polymorphism
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Adenomatous polyposis coli
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Apolipoprotein E e4 gene carrier
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Atrial septal defect
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Congenital cystic kidney disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Developmental hip dysplasia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hydrocele
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Phimosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    SF3B1 gene mutation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cardiac disorders
    Atrioventricular block complete
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Atrial thrombosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Atrial tachycardia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Atrial flutter
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Atrial fibrillation
         subjects affected / exposed
    40 / 1512 (2.65%)
    80 / 3274 (2.44%)
    4 / 284 (1.41%)
    36 / 1478 (2.44%)
         occurrences all number
    43
    168
    4
    37
    Atrial enlargement
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Arrhythmia
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Aortic valve stenosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    2
    14
    0
    5
    Aortic valve sclerosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Aortic valve incompetence
         subjects affected / exposed
    4 / 1512 (0.26%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    4
    16
    0
    4
    Angina unstable
         subjects affected / exposed
    4 / 1512 (0.26%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    4
    14
    0
    3
    Angina pectoris
         subjects affected / exposed
    24 / 1512 (1.59%)
    58 / 3274 (1.77%)
    2 / 284 (0.70%)
    32 / 1478 (2.17%)
         occurrences all number
    26
    120
    2
    32
    Acute myocardial infarction
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Atrioventricular block
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Cardiac amyloidosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cardiac aneurysm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cardiac disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Cardiac failure
         subjects affected / exposed
    15 / 1512 (0.99%)
    34 / 3274 (1.04%)
    0 / 284 (0.00%)
    19 / 1478 (1.29%)
         occurrences all number
    16
    76
    0
    22
    Cardiac failure acute
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cardiac failure chronic
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Cardiac failure congestive
         subjects affected / exposed
    15 / 1512 (0.99%)
    26 / 3274 (0.79%)
    0 / 284 (0.00%)
    11 / 1478 (0.74%)
         occurrences all number
    16
    54
    0
    11
    Cardiac flutter
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Cardiac hypertrophy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cardiac perfusion defect
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Cardiac sarcoidosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cardiac valve disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Bradycardia
         subjects affected / exposed
    12 / 1512 (0.79%)
    26 / 3274 (0.79%)
    1 / 284 (0.35%)
    13 / 1478 (0.88%)
         occurrences all number
    12
    52
    1
    13
    Bundle branch block
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bundle branch block left
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Bundle branch block right
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Cardiac ventricular thrombosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cardiomegaly
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Cardiomyopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cardiorenal syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Cardiovascular disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Chronic left ventricular failure
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Chronotropic incompetence
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Conduction disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Coronary artery disease
         subjects affected / exposed
    17 / 1512 (1.12%)
    41 / 3274 (1.25%)
    0 / 284 (0.00%)
    24 / 1478 (1.62%)
         occurrences all number
    18
    84
    0
    24
    Coronary artery occlusion
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Coronary artery stenosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    12
    0
    4
    Diastolic dysfunction
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    1
    10
    0
    4
    Dressler's syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Extrasystoles
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Heart valve incompetence
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Hypertensive cardiomyopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cardiogenic shock
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    1
    10
    0
    4
    Left atrial enlargement
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Left ventricular dysfunction
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    14
    0
    4
    Left ventricular enlargement
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Left ventricular failure
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    8
    1
    2
    Left ventricular hypertrophy
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    10
    0
    1
    Mitral valve calcification
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    11 / 1512 (0.73%)
    19 / 3274 (0.58%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    11
    38
    1
    7
    Mitral valve prolapse
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Mitral valve stenosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Myocardial ischaemia
         subjects affected / exposed
    4 / 1512 (0.26%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    4
    18
    0
    5
    Palpitations
         subjects affected / exposed
    21 / 1512 (1.39%)
    30 / 3274 (0.92%)
    1 / 284 (0.35%)
    8 / 1478 (0.54%)
         occurrences all number
    24
    70
    1
    10
    Pericardial effusion
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    4
    8
    0
    0
    Pericarditis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Prinzmetal angina
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pulmonary valve incompetence
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Right atrial dilatation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Sinus arrhythmia
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    6
    1
    2
    Sinus bradycardia
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    4
    16
    0
    4
    Sinus node dysfunction
         subjects affected / exposed
    4 / 1512 (0.26%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    4
    16
    0
    4
    Supraventricular extrasystoles
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    10
    0
    1
    Supraventricular tachycardia
         subjects affected / exposed
    2 / 1512 (0.13%)
    10 / 3274 (0.31%)
    0 / 284 (0.00%)
    8 / 1478 (0.54%)
         occurrences all number
    2
    22
    0
    9
    Systolic dysfunction
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Tachycardia
         subjects affected / exposed
    7 / 1512 (0.46%)
    14 / 3274 (0.43%)
    1 / 284 (0.35%)
    6 / 1478 (0.41%)
         occurrences all number
    7
    28
    1
    6
    Tachycardia paroxysmal
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Tricuspid valve incompetence
         subjects affected / exposed
    6 / 1512 (0.40%)
    11 / 3274 (0.34%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    7
    24
    1
    4
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Ventricular dysfunction
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Ventricular extrasystoles
         subjects affected / exposed
    9 / 1512 (0.60%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    9
    26
    1
    3
    Ventricular tachycardia
         subjects affected / exposed
    5 / 1512 (0.33%)
    14 / 3274 (0.43%)
    0 / 284 (0.00%)
    9 / 1478 (0.61%)
         occurrences all number
    6
    42
    0
    15
    Sinus tachycardia
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Akinesia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Altered state of consciousness
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Amnesia
         subjects affected / exposed
    6 / 1512 (0.40%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    6
    18
    0
    3
    Aphasia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Arachnoid cyst
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Balance disorder
         subjects affected / exposed
    8 / 1512 (0.53%)
    11 / 3274 (0.34%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    8
    22
    1
    2
    Bell's palsy
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    8
    1
    1
    Cervicogenic headache
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Carotid arteriosclerosis
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    12
    1
    2
    Carotid artery disease
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Carotid artery occlusion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Carotid artery stenosis
         subjects affected / exposed
    6 / 1512 (0.40%)
    10 / 3274 (0.31%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    6
    20
    0
    4
    Carpal tunnel syndrome
         subjects affected / exposed
    13 / 1512 (0.86%)
    22 / 3274 (0.67%)
    1 / 284 (0.35%)
    8 / 1478 (0.54%)
         occurrences all number
    14
    48
    1
    9
    Cerebellar atrophy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cerebral arteriosclerosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cerebral atrophy
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    8
    1
    1
    Cerebral ischaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cerebral microangiopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Cerebrovascular accident
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cerebrovascular disorder
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Cervical radiculopathy
         subjects affected / exposed
    6 / 1512 (0.40%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    6
    16
    0
    2
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Burning sensation
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Dysgeusia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Dysarthria
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Epilepsy
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Essential tremor
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Facial paralysis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Facial paresis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Head discomfort
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    4
    1
    0
    Headache
         subjects affected / exposed
    41 / 1512 (2.71%)
    83 / 3274 (2.54%)
    5 / 284 (1.76%)
    37 / 1478 (2.50%)
         occurrences all number
    44
    174
    5
    38
    Hemiparesis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cognitive disorder
         subjects affected / exposed
    4 / 1512 (0.26%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    4
    12
    0
    2
    Cortical laminar necrosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cubital tunnel syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Dementia
         subjects affected / exposed
    3 / 1512 (0.20%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    10
    0
    2
    Dementia Alzheimer's type
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Diabetic neuropathy
         subjects affected / exposed
    6 / 1512 (0.40%)
    11 / 3274 (0.34%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    6
    22
    1
    4
    Disturbance in attention
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Dizziness
         subjects affected / exposed
    40 / 1512 (2.65%)
    88 / 3274 (2.69%)
    6 / 284 (2.11%)
    42 / 1478 (2.84%)
         occurrences all number
    46
    192
    6
    44
    Encephalopathy
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Myelopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    5 / 1512 (0.33%)
    12 / 3274 (0.37%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    5
    26
    0
    8
    Hyporeflexia
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Hyposmia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Intercostal neuralgia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Intracranial aneurysm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Intracranial mass
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Ischaemic stroke
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Lethargy
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Loss of consciousness
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    Lumbosacral radiculopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Memory impairment
         subjects affected / exposed
    5 / 1512 (0.33%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    5
    16
    1
    2
    Migraine
         subjects affected / exposed
    5 / 1512 (0.33%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    5
    12
    0
    1
    Morton's neuralgia
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Muscle contractions involuntary
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hyperaesthesia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Nerve compression
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    3
    16
    0
    5
    Restless legs syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    18 / 1512 (1.19%)
    33 / 3274 (1.01%)
    4 / 284 (1.41%)
    11 / 1478 (0.74%)
         occurrences all number
    18
    70
    6
    11
    Pachymeningitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Paraesthesia
         subjects affected / exposed
    6 / 1512 (0.40%)
    12 / 3274 (0.37%)
    2 / 284 (0.70%)
    4 / 1478 (0.27%)
         occurrences all number
    6
    28
    3
    5
    Paralysis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Parkinson's disease
         subjects affected / exposed
    5 / 1512 (0.33%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    5
    16
    0
    3
    Partial seizures
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Periodic limb movement disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Peroneal nerve palsy
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Polyneuropathy
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Post polio syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Presyncope
         subjects affected / exposed
    6 / 1512 (0.40%)
    11 / 3274 (0.34%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    6
    22
    1
    4
    Quadrantanopia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Radiculopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Neuralgia
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Sciatica
         subjects affected / exposed
    15 / 1512 (0.99%)
    38 / 3274 (1.16%)
    1 / 284 (0.35%)
    22 / 1478 (1.49%)
         occurrences all number
    18
    84
    1
    23
    VIth nerve paralysis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Senile dementia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Sensory disturbance
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Sensory loss
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Speech disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Spinal claudication
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Syncope
         subjects affected / exposed
    16 / 1512 (1.06%)
    31 / 3274 (0.95%)
    0 / 284 (0.00%)
    15 / 1478 (1.01%)
         occurrences all number
    19
    78
    0
    20
    Taste disorder
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Tension headache
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Thoracic radiculopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Thunderclap headache
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Transient global amnesia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    4
    1
    0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Tremor
         subjects affected / exposed
    7 / 1512 (0.46%)
    12 / 3274 (0.37%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    7
    24
    1
    4
    Trigeminal neuralgia
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Ulnar neuritis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Seizure
         subjects affected / exposed
    4 / 1512 (0.26%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    5
    14
    0
    2
    Vascular dementia
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Vascular parkinsonism
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Vocal cord paralysis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Vascular encephalopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    45 / 1512 (2.98%)
    80 / 3274 (2.44%)
    2 / 284 (0.70%)
    33 / 1478 (2.23%)
         occurrences all number
    46
    170
    2
    37
    Anaemia macrocytic
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Anaemia megaloblastic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cytopenia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Blood loss anaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Bone marrow oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Coagulopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Bicytopenia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Eosinophilia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    Haemolytic anaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Polycythaemia
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Pancytopenia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Normocytic anaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Neutropenia
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Nephrogenic anaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Monoclonal B-cell lymphocytosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Microcytic anaemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    9 / 3274 (0.27%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences all number
    3
    18
    1
    5
    Macrocytosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    12
    1
    3
    Lymph node fibrosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Leukopenia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Leukocytosis
         subjects affected / exposed
    8 / 1512 (0.53%)
    12 / 3274 (0.37%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    15
    38
    0
    4
    Iron deficiency anaemia
         subjects affected / exposed
    10 / 1512 (0.66%)
    14 / 3274 (0.43%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    11
    30
    0
    4
    Increased tendency to bruise
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hypochromic anaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Hilar lymphadenopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Splenomegaly
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Thrombocytosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 1512 (0.00%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    8 / 1478 (0.54%)
         occurrences all number
    0
    16
    0
    8
    Ear and labyrinth disorders
    Deafness neurosensory
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    6
    0
    3
    Deafness bilateral
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Ear canal stenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Ear haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Ear pain
         subjects affected / exposed
    9 / 1512 (0.60%)
    12 / 3274 (0.37%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    9
    24
    0
    3
    Ear pruritus
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Eustachian tube dysfunction
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Excessive cerumen production
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Haematotympanum
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hypoacusis
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    8
    1
    3
    Mastoid disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Meniere's disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Cerumen impaction
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    3
    16
    0
    5
    Conductive deafness
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Deafness
         subjects affected / exposed
    4 / 1512 (0.26%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    12
    1
    1
    Deafness unilateral
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Otolithiasis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Sudden hearing loss
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Tinnitus
         subjects affected / exposed
    3 / 1512 (0.20%)
    13 / 3274 (0.40%)
    0 / 284 (0.00%)
    10 / 1478 (0.68%)
         occurrences all number
    3
    26
    0
    10
    Vertigo
         subjects affected / exposed
    15 / 1512 (0.99%)
    33 / 3274 (1.01%)
    4 / 284 (1.41%)
    14 / 1478 (0.95%)
         occurrences all number
    15
    66
    4
    14
    Vertigo positional
         subjects affected / exposed
    4 / 1512 (0.26%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    4
    8
    0
    0
    Otorrhoea
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    6
    0
    2
    Amaurosis fugax
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Exfoliation syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blepharospasm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Blindness
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Cataract
         subjects affected / exposed
    40 / 1512 (2.65%)
    68 / 3274 (2.08%)
    5 / 284 (1.76%)
    23 / 1478 (1.56%)
         occurrences all number
    45
    168
    8
    31
    Chalazion
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Choroidal neovascularisation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Corneal degeneration
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Corneal erosion
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Dermatochalasis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Diabetic retinopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    8 / 3274 (0.24%)
    4 / 284 (1.41%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    16
    4
    3
    Diplopia
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Dry eye
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    14
    0
    4
    Ectropion
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    Epiretinal membrane
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blepharitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Neovascular age-related macular degeneration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Macular oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Ocular hypertension
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Periorbital swelling
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eye discharge
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eye haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eye pruritus
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eye swelling
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eyelid cyst
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Eyelid ptosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Glaucoma
         subjects affected / exposed
    5 / 1512 (0.33%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    5
    26
    1
    7
    Iridocyclitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Iritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Keratitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    4
    1
    0
    Macular degeneration
         subjects affected / exposed
    7 / 1512 (0.46%)
    9 / 3274 (0.27%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    7
    18
    1
    1
    Non-proliferative retinopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Posterior capsule opacification
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Retinal artery embolism
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Retinal artery occlusion
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Retinal detachment
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    8
    1
    1
    Retinal haemorrhage
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Retinal ischaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Retinal vascular thrombosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Retinal vein occlusion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Retinopathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    Retinopathy hypertensive
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Swelling of eyelid
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Ulcerative keratitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vision blurred
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    16
    1
    4
    Visual acuity reduced
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Visual impairment
         subjects affected / exposed
    5 / 1512 (0.33%)
    10 / 3274 (0.31%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    20
    1
    4
    Vitreous detachment
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    6
    1
    1
    Vitreous floaters
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vitreous opacities
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Gastrointestinal disorders
    Change of bowel habit
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Abdominal distension
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Abdominal hernia
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    8
    1
    1
    Abdominal mass
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Abdominal pain
         subjects affected / exposed
    15 / 1512 (0.99%)
    34 / 3274 (1.04%)
    3 / 284 (1.06%)
    16 / 1478 (1.08%)
         occurrences all number
    17
    76
    3
    18
    Abdominal pain lower
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    12
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    6 / 1512 (0.40%)
    20 / 3274 (0.61%)
    3 / 284 (1.06%)
    11 / 1478 (0.74%)
         occurrences all number
    7
    44
    4
    11
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Acquired oesophageal web
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Anal fissure
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Anal incontinence
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    2 / 284 (0.70%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    4
    2
    0
    Anal prolapse
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Anal skin tags
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Anorectal discomfort
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Ascites
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Barrett's oesophagus
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    8
    1
    2
    Abdominal discomfort
         subjects affected / exposed
    0 / 1512 (0.00%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    0
    16
    1
    7
    Defaecation disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Crohn's disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Diarrhoea
         subjects affected / exposed
    41 / 1512 (2.71%)
    76 / 3274 (2.32%)
    4 / 284 (1.41%)
    31 / 1478 (2.10%)
         occurrences all number
    47
    170
    4
    34
    Diarrhoea haemorrhagic
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Diverticulitis oesophageal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Diverticulum
         subjects affected / exposed
    5 / 1512 (0.33%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    18
    0
    4
    Diverticulum intestinal
         subjects affected / exposed
    6 / 1512 (0.40%)
    16 / 3274 (0.49%)
    0 / 284 (0.00%)
    10 / 1478 (0.68%)
         occurrences all number
    6
    32
    0
    10
    Dry mouth
         subjects affected / exposed
    4 / 1512 (0.26%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    4
    8
    0
    0
    Duodenal polyp
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Duodenal ulcer
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Duodenitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Duodenogastric reflux
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Dyspepsia
         subjects affected / exposed
    8 / 1512 (0.53%)
    18 / 3274 (0.55%)
    1 / 284 (0.35%)
    9 / 1478 (0.61%)
         occurrences all number
    8
    36
    1
    9
    Chronic gastritis
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    10
    0
    3
    Colitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Colitis microscopic
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Colitis ulcerative
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Constipation
         subjects affected / exposed
    22 / 1512 (1.46%)
    49 / 3274 (1.50%)
    2 / 284 (0.70%)
    25 / 1478 (1.69%)
         occurrences all number
    23
    100
    2
    25
    Dental caries
         subjects affected / exposed
    5 / 1512 (0.33%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    18
    0
    4
    Dysphagia
         subjects affected / exposed
    11 / 1512 (0.73%)
    17 / 3274 (0.52%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences all number
    12
    36
    1
    5
    Gastrointestinal pain
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eosinophilic oesophagitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Epigastric discomfort
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    6
    0
    3
    Erosive duodenitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Eructation
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Faeces discoloured
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Faeces soft
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Flatulence
         subjects affected / exposed
    4 / 1512 (0.26%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    4
    22
    0
    7
    Food poisoning
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Frequent bowel movements
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Gastric antral vascular ectasia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Gastric disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    8
    1
    2
    Gastric mucosa erythema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Gastric ulcer
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Gastritis
         subjects affected / exposed
    12 / 1512 (0.79%)
    28 / 3274 (0.86%)
    3 / 284 (1.06%)
    13 / 1478 (0.88%)
         occurrences all number
    12
    58
    4
    13
    Gastritis erosive
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Enteritis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    16 / 1512 (1.06%)
    44 / 3274 (1.34%)
    5 / 284 (1.76%)
    23 / 1478 (1.56%)
         occurrences all number
    17
    90
    5
    23
    Odynophagia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Haematochezia
         subjects affected / exposed
    4 / 1512 (0.26%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    4
    14
    0
    3
    Haemorrhoids
         subjects affected / exposed
    9 / 1512 (0.60%)
    19 / 3274 (0.58%)
    0 / 284 (0.00%)
    10 / 1478 (0.68%)
         occurrences all number
    9
    38
    0
    10
    Hiatus hernia
         subjects affected / exposed
    7 / 1512 (0.46%)
    19 / 3274 (0.58%)
    2 / 284 (0.70%)
    10 / 1478 (0.68%)
         occurrences all number
    7
    38
    2
    10
    Ileus
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Ileus paralytic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Inflammatory bowel disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Inguinal hernia
         subjects affected / exposed
    5 / 1512 (0.33%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    5
    26
    1
    7
    Intestinal ischaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Intestinal polyp
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    12
    1
    2
    Large intestine polyp
         subjects affected / exposed
    10 / 1512 (0.66%)
    17 / 3274 (0.52%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    10
    34
    0
    7
    Lip swelling
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Melaena
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Nausea
         subjects affected / exposed
    23 / 1512 (1.52%)
    41 / 3274 (1.25%)
    1 / 284 (0.35%)
    17 / 1478 (1.15%)
         occurrences all number
    25
    90
    1
    19
    Haematemesis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Proctalgia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Pneumoperitoneum
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Rectal discharge
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 1512 (0.13%)
    7 / 3274 (0.21%)
    2 / 284 (0.70%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    14
    2
    3
    Rectal polyp
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Rectal prolapse
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Oesophageal stenosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Oesophagitis
         subjects affected / exposed
    5 / 1512 (0.33%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    5
    16
    0
    3
    Pancreatic cyst
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Pancreatic duct dilatation
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pancreatic failure
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pancreatic steatosis
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Pancreatitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pancreatitis acute
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Peptic ulcer
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Peritoneal adhesions
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Proctitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Regurgitation
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Salivary gland enlargement
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Salivary gland mass
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Stomatitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Tongue cyst
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Tongue ulceration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Tooth impacted
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Toothache
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    10
    0
    3
    Umbilical hernia
         subjects affected / exposed
    5 / 1512 (0.33%)
    10 / 3274 (0.31%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    5
    20
    0
    5
    Vomiting
         subjects affected / exposed
    16 / 1512 (1.06%)
    28 / 3274 (0.86%)
    3 / 284 (1.06%)
    9 / 1478 (0.61%)
         occurrences all number
    17
    60
    3
    10
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    20
    0
    7
    Acne
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Actinic keratosis
         subjects affected / exposed
    5 / 1512 (0.33%)
    11 / 3274 (0.34%)
    2 / 284 (0.70%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    22
    2
    4
    Alopecia
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    12
    1
    3
    Alopecia areata
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Angioedema
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Blister
         subjects affected / exposed
    4 / 1512 (0.26%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    4
    14
    0
    3
    Cutaneous calcification
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Decubitus ulcer
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Dermal cyst
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Dermatitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    14
    1
    4
    Dermatitis acneiform
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    8
    0
    3
    Lichen planus
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Diabetic foot
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Diabetic ulcer
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    0
    2
    Dry skin
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    10
    0
    1
    Dyshidrotic eczema
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Ecchymosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Eczema
         subjects affected / exposed
    6 / 1512 (0.40%)
    14 / 3274 (0.43%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    6
    28
    1
    7
    Eczema asteatotic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Erythema
         subjects affected / exposed
    3 / 1512 (0.20%)
    10 / 3274 (0.31%)
    5 / 284 (1.76%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    22
    5
    3
    Hand dermatitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Hidradenitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    5 / 1512 (0.33%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    5
    16
    0
    3
    Hyperkeratosis
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Hypertrophic scar
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Ingrowing nail
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    4
    8
    0
    0
    Intertrigo
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Lentigo
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    0
    2
    Pityriasis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pemphigus
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Polymorphic light eruption
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pruritus
         subjects affected / exposed
    8 / 1512 (0.53%)
    16 / 3274 (0.49%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    10
    40
    1
    9
    Pruritus allergic
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Psoriasis
         subjects affected / exposed
    6 / 1512 (0.40%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    6
    22
    0
    5
    Purpura senile
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Rash
         subjects affected / exposed
    13 / 1512 (0.86%)
    23 / 3274 (0.70%)
    1 / 284 (0.35%)
    9 / 1478 (0.61%)
         occurrences all number
    14
    48
    1
    9
    Rash erythematous
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Rash pruritic
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    10
    3
    0
    Reactive perforating collagenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    0
    2
    Rosacea
         subjects affected / exposed
    3 / 1512 (0.20%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    10
    1
    1
    Lipohypertrophy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Milia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Nail dystrophy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    0
    2
    Panniculitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pityriasis rosea
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Sebaceous hyperplasia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Skin discolouration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Skin fibrosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Skin indentation
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Skin lesion
         subjects affected / exposed
    6 / 1512 (0.40%)
    14 / 3274 (0.43%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    9
    34
    1
    7
    Skin reaction
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Skin texture abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Skin ulcer
         subjects affected / exposed
    6 / 1512 (0.40%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    6 / 1478 (0.41%)
         occurrences all number
    9
    34
    1
    7
    Stasis dermatitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    2 / 284 (0.70%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    8
    2
    0
    Subcutaneous emphysema
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Urticaria
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    10
    0
    1
    Xanthoma
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Sensitive skin
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Renal and urinary disorders
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Acute kidney injury
         subjects affected / exposed
    11 / 1512 (0.73%)
    29 / 3274 (0.89%)
    0 / 284 (0.00%)
    18 / 1478 (1.22%)
         occurrences all number
    11
    60
    0
    19
    Albuminuria
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Azotaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bladder disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bladder diverticulum
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Bladder irritation
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bladder outlet obstruction
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Bladder prolapse
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bladder stenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Chronic kidney disease
         subjects affected / exposed
    23 / 1512 (1.52%)
    44 / 3274 (1.34%)
    1 / 284 (0.35%)
    20 / 1478 (1.35%)
         occurrences all number
    23
    88
    1
    20
    Cystitis noninfective
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Neurogenic bladder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Dysuria
         subjects affected / exposed
    6 / 1512 (0.40%)
    10 / 3274 (0.31%)
    2 / 284 (0.70%)
    2 / 1478 (0.14%)
         occurrences all number
    6
    20
    2
    2
    End stage renal disease
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Genitourinary symptom
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Glycosuria
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Haematuria
         subjects affected / exposed
    14 / 1512 (0.93%)
    27 / 3274 (0.82%)
    0 / 284 (0.00%)
    13 / 1478 (0.88%)
         occurrences all number
    17
    60
    0
    13
    Hydronephrosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Hypertensive nephropathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hypertonic bladder
         subjects affected / exposed
    5 / 1512 (0.33%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    5
    22
    0
    6
    Leukocyturia
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Lower urinary tract symptoms
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    10
    0
    4
    Microalbuminuria
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Micturition urgency
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    6
    1
    1
    Nephritic syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    15 / 1512 (0.99%)
    26 / 3274 (0.79%)
    1 / 284 (0.35%)
    10 / 1478 (0.68%)
         occurrences all number
    18
    58
    1
    10
    Nephropathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Diabetic nephropathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Nocturia
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Polyuria
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Proteinuria
         subjects affected / exposed
    4 / 1512 (0.26%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    4
    12
    0
    2
    Pyelocaliectasis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Renal aneurysm
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Renal artery stenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    6
    1
    2
    Renal colic
         subjects affected / exposed
    4 / 1512 (0.26%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    4
    12
    0
    2
    Renal cyst
         subjects affected / exposed
    9 / 1512 (0.60%)
    31 / 3274 (0.95%)
    0 / 284 (0.00%)
    22 / 1478 (1.49%)
         occurrences all number
    9
    64
    0
    23
    Renal disorder
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Renal failure
         subjects affected / exposed
    5 / 1512 (0.33%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    5
    22
    0
    6
    Renal impairment
         subjects affected / exposed
    24 / 1512 (1.59%)
    54 / 3274 (1.65%)
    0 / 284 (0.00%)
    30 / 1478 (2.03%)
         occurrences all number
    28
    118
    0
    31
    Renal mass
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Renal necrosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Renal pain
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Strangury
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Stress urinary incontinence
         subjects affected / exposed
    4 / 1512 (0.26%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    4
    8
    0
    0
    Pollakiuria
         subjects affected / exposed
    6 / 1512 (0.40%)
    10 / 3274 (0.31%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    6
    20
    0
    4
    Ureterolithiasis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Urge incontinence
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Urinary bladder haemorrhage
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Urinary incontinence
         subjects affected / exposed
    6 / 1512 (0.40%)
    12 / 3274 (0.37%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences all number
    6
    24
    1
    5
    Urinary retention
         subjects affected / exposed
    5 / 1512 (0.33%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    18
    0
    4
    Urinary tract disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Urinary tract inflammation
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Urine odour abnormal
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Urethral stenosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    6
    0
    3
    Endocrine disorders
    Adrenal mass
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    1
    10
    0
    4
    Goitre
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    2
    12
    0
    4
    Hyperparathyroidism
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Hyperparathyroidism primary
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hyperprolactinaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Hyperthyroidism
         subjects affected / exposed
    6 / 1512 (0.40%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    6
    22
    0
    5
    Hypogonadism
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Hypothyroidism
         subjects affected / exposed
    10 / 1512 (0.66%)
    22 / 3274 (0.67%)
    2 / 284 (0.70%)
    10 / 1478 (0.68%)
         occurrences all number
    10
    44
    2
    10
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Thyroid calcification
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Thyroid mass
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Musculoskeletal and connective tissue disorders
    Dupuytren's contracture
         subjects affected / exposed
    3 / 1512 (0.20%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    3
    16
    0
    5
    Ankle impingement
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Arthralgia
         subjects affected / exposed
    94 / 1512 (6.22%)
    201 / 3274 (6.14%)
    5 / 284 (1.76%)
    102 / 1478 (6.90%)
         occurrences all number
    107
    456
    5
    116
    Arthritis
         subjects affected / exposed
    14 / 1512 (0.93%)
    28 / 3274 (0.86%)
    2 / 284 (0.70%)
    12 / 1478 (0.81%)
         occurrences all number
    14
    56
    2
    12
    Arthropathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Back pain
         subjects affected / exposed
    67 / 1512 (4.43%)
    126 / 3274 (3.85%)
    8 / 284 (2.82%)
    51 / 1478 (3.45%)
         occurrences all number
    72
    272
    8
    56
    Bone atrophy
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bone cyst
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Bursitis
         subjects affected / exposed
    4 / 1512 (0.26%)
    13 / 3274 (0.40%)
    3 / 284 (1.06%)
    6 / 1478 (0.41%)
         occurrences all number
    5
    28
    3
    6
    Cervical spinal stenosis
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Chondrocalcinosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Chondropathy
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Chronic kidney disease-mineral and bone disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Coccydynia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Costochondritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Degenerative bone disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Diffuse idiopathic skeletal hyperostosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Exostosis
         subjects affected / exposed
    3 / 1512 (0.20%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    10
    1
    1
    Limb discomfort
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Flank pain
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    14
    0
    4
    Foot deformity
         subjects affected / exposed
    4 / 1512 (0.26%)
    9 / 3274 (0.27%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    6
    22
    1
    4
    Fracture pain
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Greater trochanteric pain syndrome
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Groin pain
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    14
    0
    4
    Haemarthrosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Haematoma muscle
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Intervertebral disc degeneration
         subjects affected / exposed
    6 / 1512 (0.40%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    6
    22
    0
    5
    Intervertebral disc disorder
         subjects affected / exposed
    5 / 1512 (0.33%)
    10 / 3274 (0.31%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    20
    1
    4
    Intervertebral disc protrusion
         subjects affected / exposed
    7 / 1512 (0.46%)
    17 / 3274 (0.52%)
    1 / 284 (0.35%)
    9 / 1478 (0.61%)
         occurrences all number
    7
    36
    1
    10
    Joint effusion
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Joint instability
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Joint stiffness
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Joint swelling
         subjects affected / exposed
    6 / 1512 (0.40%)
    12 / 3274 (0.37%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences all number
    6
    24
    1
    5
    Ligament calcification
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Fibromyalgia
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Lumbar spinal stenosis
         subjects affected / exposed
    4 / 1512 (0.26%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    4
    16
    1
    3
    Neck mass
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Mobility decreased
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Muscle atrophy
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    0
    8
    0
    4
    Muscle contracture
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Muscle discomfort
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Muscle fatigue
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Muscle oedema
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Muscle rigidity
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Muscle spasms
         subjects affected / exposed
    26 / 1512 (1.72%)
    37 / 3274 (1.13%)
    1 / 284 (0.35%)
    10 / 1478 (0.68%)
         occurrences all number
    26
    74
    1
    10
    Muscle tightness
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Muscular weakness
         subjects affected / exposed
    8 / 1512 (0.53%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    8
    26
    1
    4
    Musculoskeletal chest pain
         subjects affected / exposed
    4 / 1512 (0.26%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    4
    16
    1
    3
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Musculoskeletal disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    3 / 1512 (0.20%)
    7 / 3274 (0.21%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    16
    2
    3
    Myalgia
         subjects affected / exposed
    19 / 1512 (1.26%)
    48 / 3274 (1.47%)
    3 / 284 (1.06%)
    26 / 1478 (1.76%)
         occurrences all number
    20
    100
    3
    27
    Myopathy
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Meniscal degeneration
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Pain in extremity
         subjects affected / exposed
    43 / 1512 (2.84%)
    86 / 3274 (2.63%)
    5 / 284 (1.76%)
    38 / 1478 (2.57%)
         occurrences all number
    47
    194
    5
    45
    Periarthritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Periostitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Plantar fasciitis
         subjects affected / exposed
    9 / 1512 (0.60%)
    14 / 3274 (0.43%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    9
    30
    2
    4
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Psoriatic arthropathy
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    5 / 1512 (0.33%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    20
    0
    5
    Rib deformity
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Rotator cuff syndrome
         subjects affected / exposed
    14 / 1512 (0.93%)
    30 / 3274 (0.92%)
    2 / 284 (0.70%)
    14 / 1478 (0.95%)
         occurrences all number
    16
    66
    2
    15
    Neck pain
         subjects affected / exposed
    16 / 1512 (1.06%)
    31 / 3274 (0.95%)
    1 / 284 (0.35%)
    14 / 1478 (0.95%)
         occurrences all number
    17
    64
    1
    14
    Osteoarthritis
         subjects affected / exposed
    60 / 1512 (3.97%)
    119 / 3274 (3.63%)
    6 / 284 (2.11%)
    53 / 1478 (3.59%)
         occurrences all number
    68
    268
    7
    59
    Osteochondrosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    Osteonecrosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Osteopenia
         subjects affected / exposed
    2 / 1512 (0.13%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    2
    12
    0
    4
    Osteoporosis
         subjects affected / exposed
    3 / 1512 (0.20%)
    13 / 3274 (0.40%)
    2 / 284 (0.70%)
    8 / 1478 (0.54%)
         occurrences all number
    3
    26
    2
    8
    Osteoporosis postmenopausal
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Patellofemoral pain syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    SLE arthritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Tenosynovitis stenosans
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Sacroiliac joint dysfunction
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Sacroiliitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Scoliosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Soft tissue swelling
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    12 / 1512 (0.79%)
    29 / 3274 (0.89%)
    2 / 284 (0.70%)
    15 / 1478 (1.01%)
         occurrences all number
    12
    58
    2
    15
    Spinal pain
         subjects affected / exposed
    4 / 1512 (0.26%)
    11 / 3274 (0.34%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    4
    24
    0
    8
    Spinal stenosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Spondylitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Spondylolisthesis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Synovial cyst
         subjects affected / exposed
    7 / 1512 (0.46%)
    12 / 3274 (0.37%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    7
    24
    0
    5
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Tendon disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    0
    8
    0
    4
    Tendonitis
         subjects affected / exposed
    3 / 1512 (0.20%)
    9 / 3274 (0.27%)
    2 / 284 (0.70%)
    4 / 1478 (0.27%)
         occurrences all number
    3
    18
    2
    4
    Tenosynovitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Sacral pain
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Torticollis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Trismus
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Trigger finger
         subjects affected / exposed
    10 / 1512 (0.66%)
    18 / 3274 (0.55%)
    1 / 284 (0.35%)
    7 / 1478 (0.47%)
         occurrences all number
    10
    40
    1
    9
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Abscess
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bronchitis
         subjects affected / exposed
    32 / 1512 (2.12%)
    60 / 3274 (1.83%)
    1 / 284 (0.35%)
    27 / 1478 (1.83%)
         occurrences all number
    37
    138
    1
    31
    Abscess of eyelid
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Acarodermatitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Acute sinusitis
         subjects affected / exposed
    10 / 1512 (0.66%)
    17 / 3274 (0.52%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    13
    40
    0
    7
    Appendicitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Arthritis infective
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    0
    2
    Aspergillus infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Asymptomatic COVID-19
         subjects affected / exposed
    4 / 1512 (0.26%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    4
    10
    0
    1
    Asymptomatic bacteriuria
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bacteraemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bacterial infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Bartholinitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Blister infected
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Body tinea
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Borrelia infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Breast cellulitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Abscess limb
         subjects affected / exposed
    3 / 1512 (0.20%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    10
    0
    2
    Dacryocystitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Cystitis
         subjects affected / exposed
    6 / 1512 (0.40%)
    13 / 3274 (0.40%)
    1 / 284 (0.35%)
    6 / 1478 (0.41%)
         occurrences all number
    7
    30
    1
    7
    Device related infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Diverticulitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    11 / 3274 (0.34%)
    2 / 284 (0.70%)
    7 / 1478 (0.47%)
         occurrences all number
    2
    24
    2
    8
    Ear infection
         subjects affected / exposed
    5 / 1512 (0.33%)
    16 / 3274 (0.49%)
    1 / 284 (0.35%)
    10 / 1478 (0.68%)
         occurrences all number
    6
    40
    1
    13
    Eczema infected
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Epididymitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bronchitis viral
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    COVID-19
         subjects affected / exposed
    178 / 1512 (11.77%)
    406 / 3274 (12.40%)
    52 / 284 (18.31%)
    176 / 1478 (11.91%)
         occurrences all number
    183
    832
    53
    180
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Candida infection
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    5
    12
    0
    1
    Cellulitis
         subjects affected / exposed
    20 / 1512 (1.32%)
    43 / 3274 (1.31%)
    3 / 284 (1.06%)
    20 / 1478 (1.35%)
         occurrences all number
    26
    98
    3
    20
    Chronic sinusitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    2
    16
    0
    6
    Conjunctivitis
         subjects affected / exposed
    4 / 1512 (0.26%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    4
    12
    0
    2
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Coronavirus infection
         subjects affected / exposed
    5 / 1512 (0.33%)
    14 / 3274 (0.43%)
    4 / 284 (1.41%)
    5 / 1478 (0.34%)
         occurrences all number
    5
    28
    4
    5
    Dermatophytosis of nail
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Erysipelas
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Genital herpes
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    External ear cellulitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eye infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Eye infection viral
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Eyelid infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Folliculitis
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Fungal foot infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    Furuncle
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Gangrene
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    6
    1
    1
    Gastroenteritis
         subjects affected / exposed
    14 / 1512 (0.93%)
    27 / 3274 (0.82%)
    0 / 284 (0.00%)
    13 / 1478 (0.88%)
         occurrences all number
    14
    54
    0
    13
    Gastroenteritis clostridial
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 1512 (0.13%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    2
    16
    0
    6
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Genital candidiasis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Erythema migrans
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Gingivitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    5 / 3274 (0.15%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    10
    1
    3
    Influenza
         subjects affected / exposed
    18 / 1512 (1.19%)
    33 / 3274 (1.01%)
    0 / 284 (0.00%)
    15 / 1478 (1.01%)
         occurrences all number
    18
    68
    0
    16
    Gynaecological chlamydia infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Helicobacter gastritis
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Helicobacter infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences all number
    0
    12
    1
    5
    Herpes dermatitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Herpes simplex
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    4
    1
    0
    Herpes virus infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    5
    14
    0
    2
    Herpes zoster
         subjects affected / exposed
    16 / 1512 (1.06%)
    25 / 3274 (0.76%)
    0 / 284 (0.00%)
    9 / 1478 (0.61%)
         occurrences all number
    18
    60
    0
    12
    Herpes zoster infection neurological
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hordeolum
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Infected bite
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    3
    12
    1
    2
    Infected dermal cyst
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Infected skin ulcer
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    4
    8
    0
    0
    Groin abscess
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Injection site cellulitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    6
    0
    2
    Oral fungal infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Klebsiella infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Labyrinthitis
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Laryngitis
         subjects affected / exposed
    5 / 1512 (0.33%)
    8 / 3274 (0.24%)
    1 / 284 (0.35%)
    2 / 1478 (0.14%)
         occurrences all number
    5
    16
    1
    2
    Localised infection
         subjects affected / exposed
    3 / 1512 (0.20%)
    13 / 3274 (0.40%)
    0 / 284 (0.00%)
    10 / 1478 (0.68%)
         occurrences all number
    3
    26
    0
    10
    Lower respiratory tract infection
         subjects affected / exposed
    29 / 1512 (1.92%)
    55 / 3274 (1.68%)
    7 / 284 (2.46%)
    19 / 1478 (1.29%)
         occurrences all number
    43
    172
    8
    35
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Lyme disease
         subjects affected / exposed
    1 / 1512 (0.07%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    1
    6
    0
    2
    Lymphangitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Mastitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Nail bed infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    6
    0
    3
    Nail infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    61 / 1512 (4.03%)
    110 / 3274 (3.36%)
    5 / 284 (1.76%)
    44 / 1478 (2.98%)
         occurrences all number
    70
    256
    5
    53
    Onychomycosis
         subjects affected / exposed
    12 / 1512 (0.79%)
    14 / 3274 (0.43%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    12
    30
    0
    3
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Kidney infection
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Oral herpes
         subjects affected / exposed
    1 / 1512 (0.07%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    1
    8
    0
    3
    Pseudomonas infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Orchitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Osteomyelitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    12
    0
    6
    Otitis externa
         subjects affected / exposed
    2 / 1512 (0.13%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    2
    16
    0
    6
    Otitis media
         subjects affected / exposed
    4 / 1512 (0.26%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    4
    14
    0
    3
    Otitis media acute
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Otitis media chronic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Paronychia
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    10
    0
    2
    Parotitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Penile infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Perineal infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Periodontitis
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Pharyngitis
         subjects affected / exposed
    8 / 1512 (0.53%)
    10 / 3274 (0.31%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    8
    20
    0
    2
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Pneumonia
         subjects affected / exposed
    28 / 1512 (1.85%)
    50 / 3274 (1.53%)
    2 / 284 (0.70%)
    20 / 1478 (1.35%)
         occurrences all number
    29
    102
    2
    20
    Post procedural infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Oral infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Pyelonephritis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Rectal abscess
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    7 / 1512 (0.46%)
    16 / 3274 (0.49%)
    0 / 284 (0.00%)
    9 / 1478 (0.61%)
         occurrences all number
    8
    34
    0
    9
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    6
    0
    2
    Rhinitis
         subjects affected / exposed
    7 / 1512 (0.46%)
    12 / 3274 (0.37%)
    3 / 284 (1.06%)
    2 / 1478 (0.14%)
         occurrences all number
    8
    26
    3
    2
    Root canal infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Rotavirus infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Sepsis
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Septic shock
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Sinobronchitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    0
    2
    Sinusitis
         subjects affected / exposed
    14 / 1512 (0.93%)
    45 / 3274 (1.37%)
    1 / 284 (0.35%)
    30 / 1478 (2.03%)
         occurrences all number
    15
    98
    1
    33
    Sinusitis bacterial
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    6
    0
    3
    Skin candida
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Skin infection
         subjects affected / exposed
    2 / 1512 (0.13%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    2
    8
    0
    2
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Tinea infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Vestibular neuronitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    12
    1
    5
    Staphylococcal infection
         subjects affected / exposed
    5 / 1512 (0.33%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    5
    10
    0
    0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Staphylococcal skin infection
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    4 / 1512 (0.26%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    4
    16
    0
    4
    Suspected COVID-19
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    0
    8
    0
    4
    Tick-borne fever
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Tooth abscess
         subjects affected / exposed
    8 / 1512 (0.53%)
    21 / 3274 (0.64%)
    1 / 284 (0.35%)
    12 / 1478 (0.81%)
         occurrences all number
    8
    44
    1
    13
    Tooth infection
         subjects affected / exposed
    5 / 1512 (0.33%)
    9 / 3274 (0.27%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    6
    20
    1
    3
    Tracheitis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Tracheobronchitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    56 / 1512 (3.70%)
    110 / 3274 (3.36%)
    4 / 284 (1.41%)
    50 / 1478 (3.38%)
         occurrences all number
    63
    248
    4
    57
    Urinary tract infection
         subjects affected / exposed
    77 / 1512 (5.09%)
    147 / 3274 (4.49%)
    10 / 284 (3.52%)
    60 / 1478 (4.06%)
         occurrences all number
    103
    418
    12
    94
    Vaginal infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Varicella zoster virus infection
         subjects affected / exposed
    2 / 1512 (0.13%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Tinea pedis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Viral infection
         subjects affected / exposed
    8 / 1512 (0.53%)
    12 / 3274 (0.37%)
    2 / 284 (0.70%)
    2 / 1478 (0.14%)
         occurrences all number
    8
    24
    2
    2
    Vulvitis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    1 / 284 (0.35%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    4
    1
    1
    Wound infection
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 1512 (0.00%)
    4 / 3274 (0.12%)
    1 / 284 (0.35%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    8
    1
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 1512 (0.26%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    18
    0
    4
    Carbohydrate intolerance
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Cachexia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Acidosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Abnormal loss of weight
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Dehydration
         subjects affected / exposed
    10 / 1512 (0.66%)
    21 / 3274 (0.64%)
    0 / 284 (0.00%)
    11 / 1478 (0.74%)
         occurrences all number
    10
    42
    0
    11
    Fructose intolerance
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Folate deficiency
         subjects affected / exposed
    2 / 1512 (0.13%)
    5 / 3274 (0.15%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    2
    10
    0
    3
    Fluid retention
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Electrolyte imbalance
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Diabetic metabolic decompensation
         subjects affected / exposed
    4 / 1512 (0.26%)
    8 / 3274 (0.24%)
    0 / 284 (0.00%)
    4 / 1478 (0.27%)
         occurrences all number
    4
    16
    0
    4
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Diabetic complication
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    6
    0
    3
    Diabetes mellitus inadequate control
         subjects affected / exposed
    114 / 1512 (7.54%)
    226 / 3274 (6.90%)
    3 / 284 (1.06%)
    109 / 1478 (7.37%)
         occurrences all number
    119
    480
    3
    118
    Diabetes mellitus
         subjects affected / exposed
    98 / 1512 (6.48%)
    205 / 3274 (6.26%)
    7 / 284 (2.46%)
    100 / 1478 (6.77%)
         occurrences all number
    100
    434
    7
    110
    Glucose tolerance impaired
         subjects affected / exposed
    15 / 1512 (0.99%)
    25 / 3274 (0.76%)
    0 / 284 (0.00%)
    10 / 1478 (0.68%)
         occurrences all number
    15
    50
    0
    10
    Hypokalaemia
         subjects affected / exposed
    19 / 1512 (1.26%)
    32 / 3274 (0.98%)
    0 / 284 (0.00%)
    13 / 1478 (0.88%)
         occurrences all number
    22
    70
    0
    13
    Hypercalcaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    6
    0
    3
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    6 / 1512 (0.40%)
    16 / 3274 (0.49%)
    1 / 284 (0.35%)
    9 / 1478 (0.61%)
         occurrences all number
    7
    34
    1
    9
    Hyperhomocysteinaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    8 / 1512 (0.53%)
    17 / 3274 (0.52%)
    1 / 284 (0.35%)
    8 / 1478 (0.54%)
         occurrences all number
    10
    40
    2
    8
    Hyperlipidaemia
         subjects affected / exposed
    7 / 1512 (0.46%)
    12 / 3274 (0.37%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    8
    26
    1
    4
    Hypermagnesaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    5 / 1512 (0.33%)
    10 / 3274 (0.31%)
    1 / 284 (0.35%)
    4 / 1478 (0.27%)
         occurrences all number
    5
    20
    1
    4
    Hypocalcaemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    3
    12
    0
    3
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Hypervolaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    0
    6
    0
    3
    Hypervitaminosis D
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    9 / 1512 (0.60%)
    16 / 3274 (0.49%)
    0 / 284 (0.00%)
    7 / 1478 (0.47%)
         occurrences all number
    9
    32
    0
    7
    Hypertriglyceridaemia
         subjects affected / exposed
    10 / 1512 (0.66%)
    16 / 3274 (0.49%)
    0 / 284 (0.00%)
    6 / 1478 (0.41%)
         occurrences all number
    11
    34
    0
    6
    Hyperphosphataemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Hypernatraemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    3
    6
    0
    0
    Gout
         subjects affected / exposed
    15 / 1512 (0.99%)
    37 / 3274 (1.13%)
    1 / 284 (0.35%)
    21 / 1478 (1.42%)
         occurrences all number
    19
    96
    1
    28
    Latent autoimmune diabetes in adults
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Magnesium deficiency
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Malnutrition
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Metabolic acidosis
         subjects affected / exposed
    1 / 1512 (0.07%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    5 / 1478 (0.34%)
         occurrences all number
    1
    12
    0
    5
    Metabolic disorder
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Obesity
         subjects affected / exposed
    2 / 1512 (0.13%)
    3 / 3274 (0.09%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    2
    6
    0
    1
    Overweight
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    1 / 284 (0.35%)
    0 / 1478 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Postprandial hypoglycaemia
         subjects affected / exposed
    0 / 1512 (0.00%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    0
    2
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    32 / 1512 (2.12%)
    77 / 3274 (2.35%)
    4 / 284 (1.41%)
    41 / 1478 (2.77%)
         occurrences all number
    32
    154
    4
    41
    Vitamin B complex deficiency
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    8 / 1512 (0.53%)
    10 / 3274 (0.31%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    8
    20
    0
    2
    Hyponatraemia
         subjects affected / exposed
    5 / 1512 (0.33%)
    11 / 3274 (0.34%)
    1 / 284 (0.35%)
    5 / 1478 (0.34%)
         occurrences all number
    7
    28
    1
    6
    Hypophosphataemia
         subjects affected / exposed
    3 / 1512 (0.20%)
    4 / 3274 (0.12%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    3
    8
    0
    1
    Hypovolaemia
         subjects affected / exposed
    1 / 1512 (0.07%)
    1 / 3274 (0.03%)
    0 / 284 (0.00%)
    0 / 1478 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Impaired fasting glucose
         subjects affected / exposed
    4 / 1512 (0.26%)
    6 / 3274 (0.18%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    4
    12
    0
    2
    Insulin resistance
         subjects affected / exposed
    1 / 1512 (0.07%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    1 / 1478 (0.07%)
         occurrences all number
    1
    4
    0
    1
    Iron deficiency
         subjects affected / exposed
    5 / 1512 (0.33%)
    7 / 3274 (0.21%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    5
    16
    0
    3
    Lactic acidosis
         subjects affected / exposed
    0 / 1512 (0.00%)
    2 / 3274 (0.06%)
    0 / 284 (0.00%)
    2 / 1478 (0.14%)
         occurrences all number
    0
    4
    0
    2
    Vitamin B12 deficiency
         subjects affected / exposed
    6 / 1512 (0.40%)
    9 / 3274 (0.27%)
    0 / 284 (0.00%)
    3 / 1478 (0.20%)
         occurrences all number
    6
    18
    0
    3
    Vitamin D deficiency
         subjects affected / exposed
    14 / 1512 (0.93%)
    30 / 3274 (0.92%)
    1 / 284 (0.35%)
    15 / 1478 (1.01%)
         occurrences all number
    14
    62
    1
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Nov 2018
    -To account for the need to provide an initial inclisiran dose and a second dose of inclisiran at Day 90 for the subjects receiving placebo in the Phase III feeder studies (Study ORION-9/ORION-10/ORION-11). -the first dose on Day 1 of Study ORION-8 will be blinded (placebo or inclisiran) so that the integrity of the blind of the feeder studies is maintained. -All subjects on placebo in the Phase III feeder studies will receive their first dose of inclisiran on Day 1, and all subjects receiving inclisiran in the Phase III feeder studies will receive placebo on Day 1 of Study ORION-8 (thereby maintaining their every 6-month administration of inclisiran).
    06 Oct 2020
    -Address the change in sponsorship from The Medicines Company to Novartis after acquisition of The Medicines Company by Novartis in January 2020. -Introduction of Novartis protocol number and IMP code: CKJX83906 and KJX839 respectively -Handling of protocol deviations including those for COVID-19 related issues -COVID-19 considerations: remote visits and extended visit windows. -Removing Section 7.3 Assessment of Pharmacodynamics as deem not relevant -Updating Section 5.1.5 about reporting of drug and device deficiencies when using pre-filled syringe -Incorporation of language about Sweden Specific Protocol Amendment in Section 3.1 -Amending Section 8.4.3.2 – Pregnancy, to include follow up on newborns for 12 months -Additional feeder study to Study ORION-8 was added: Study A12201E1 (also referred to as ORION-3) subjects can move over to Study ORION-8 after completing the treatment in the Phase II study. -Study A12302 (ORION-5) was deleted as feeder study to Study ORION-8

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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