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    Clinical Trial Results:
    A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19 A Phase III Multi-center, Open-label Sub-study in Adults to Assess the Safety, PK, and Immunogenicity of Repeat Doses of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061) (The PROVENT Repeat Dose Sub-study)

    Summary
    EudraCT number
    		 2020-004356-16
    Trial protocol
    		 GB   BE   FR  
    Global end of trial date
    09 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2024
    First version publication date
    22 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D8850C00002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04625725
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151, 85, Södertälje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca, 001 18772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, 001 18772409479, information.center@astrazeneca.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
    14 Mar 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jul 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    In the Main Study the efficacy objective was to estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 prior to Day 183; the safety objective was to assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo. In the Sub Study the main objective was to evaluate the safety and tolerability of repeat doses of AZD7442 300 mg and 600 mg IM
    Protection of trial subjects
    The study was performed in compliance with International Council for Harmonisation (ICH) Good Clinical Practice, including the archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Nov 2020
    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
    United States: 3719
    Country: Number of subjects enrolled
    United Kingdom: 923
    Country: Number of subjects enrolled
    Belgium: 308
    Country: Number of subjects enrolled
    France: 182
    Country: Number of subjects enrolled
    Spain: 65
    Worldwide total number of subjects
    5197
    EEA total number of subjects
    555
    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)
    3971
    From 65 to 84 years
    1206
    85 years and over
    20

    Subject disposition

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    Recruitment
    Recruitment details
    		 In the Main Study 5150 participants were planned to be randomized in a 2:1 ratio to receive a single IM dose of AZD7442 or saline placebo on Day 1 (approximately 3433 in the AZD7442 group and 1717 in the placebo). Approximately 500 eligible participants from the PROVENT Parent study were planned to be included in the Sub Study.

    Pre-assignment
    Screening details
    		 Overall 5973 participants were screened in the Main Study

    Period 1
    Period 1 title
    Provent Main Study
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD7442
    Arm description
    		 300 mg (AZD8895 and AZD1061)
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD7442
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of 300 mg of AZD7442 consisted of 2 sequential gluteal IM injections, one for each mAb component tixagevimab (AZD8895) and cilgavimab (AZD1061).

    Arm title
    		 Placebo
    Arm description
    		 Saline Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (saline 0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of 2 IM injections of 1.5 mL each

    Number of subjects in period 1
    		AZD7442 Placebo
    Started
    3460
    1737
    Completed
    2490
    1179
    Not completed
    970
    558
         Adverse event, serious fatal
    22
    10
         Physician decision
    5
    -
         MISSING REASON
    -
    1
         WITHDRAWAL OF CONSENT
    3
    2
         PARTICIPANT DID NOT ATTEND VISIT
    2
    2
         Consent withdrawn by subject
    242
    144
         Adverse event, non-fatal
    2
    1
         PARTICIPANT NOT COMPLIANT
    1
    1
         INCARCERATION
    3
    -
         PARTICIPANT NOT FULFILLING INCLUSION CRITERIA
    1
    -
         MOVED ABROAD / LOCATION
    7
    2
         Lost to follow-up
    357
    200
         Participants dosed in sub-study
    310
    193
         PARTICIPANT COULD NOT BE REACHED PRIOR TO DBL
    14
    2
         Protocol deviation
    1
    -
    Period 2
    Period 2 title
    Provent Sub Study
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group1
    Arm description
    		 2 doses of AZD7442 300mg, 10-14 months schedule
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD7442
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of AZD7442 300mg, 10-14 months schedule A single dose of AZD7442 consisted of 2 sequential gluteal IM injections, one for each mAb component tixagevimab (AZD8895) and cilgavimab (AZD1061).

    Arm title
    		 Group 2
    Arm description
    		 2 doses ofAZD7442 300mg, 6 month schedule
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD7442
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses ofAZD7442 300mg, 6 month schedule. A single dose of AZD7442 consisted of 2 sequential gluteal IM injections, one for each mAb component tixagevimab (AZD8895) and cilgavimab (AZD1061).

    Arm title
    		 Group 3a
    Arm description
    		 2 doses of AZD7442 300mg, 10-14 months schedule + 2 doses of AZD7442 600mg, 6 month schedule;
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD7442
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of AZD7442 300mg, 10-14 months schedule + 2 doses of AZD7442 600mg, 6 month schedule; A single dose of AZD7442 consisted of 2 sequential gluteal IM injections, one for each mAb component tixagevimab (AZD8895) and cilgavimab (AZD1061).

    Arm title
    		 Group 3b
    Arm description
    		 1 dose of AZD7442 300mg, 6 month schedule + 2 doses of AZD7442 600mg, 6 month schedule
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD7442
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of AZD7442 300mg, 6 month schedule + 2 doses of AZD7442 600mg, 6 month schedule. A single dose of AZD7442 consisted of 2 sequential gluteal IM injections, one for each mAb component tixagevimab (AZD8895) and cilgavimab (AZD1061).

    Number of subjects in period 2 [1]
    		Group1 Group 2 Group 3a Group 3b
    Started
    234
    119
    76
    74
    Completed
    194
    90
    64
    61
    Not completed
    40
    29
    12
    13
         Adverse event, serious fatal
    8
    5
    -
    1
         NON COMPLIANCE BY SUBJECT
    -
    -
    -
    1
         Consent withdrawn by subject
    11
    13
    5
    6
         SUBJECT MOVED OUT OF AREA
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    1
         SUBJECT WAS MOVING AWAY
    1
    -
    -
    -
         Lost to follow-up
    20
    10
    6
    4
         SUBJECT'S DECLINING HEALTH
    -
    -
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only a subset of participants from Main study entered the Sub Study

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD7442
    Reporting group description
    		 300 mg (AZD8895 and AZD1061)

    Reporting group title
    Placebo
    Reporting group description
    		 Saline Placebo

    Reporting group values
    		 AZD7442 Placebo Total
    Number of subjects
    		 3460 1737 5197
    Age Categorical
    For the Main Study FAS population is considered
    Units: Participants
        >= 18 - < 65 years
    		 2643 1328 3971
        >= 65 - < 85 years
    		 805 401 1206
        >= 85 years
    		 12 8 20
    Age Continuous
    Main Study: FAS population - Sub Study : As Treated
    Units: years
        arithmetic mean (standard deviation)
    		 53.65 ( 14.99 ) 53.27 ( 14.93 ) -
    Sex: Female, Male
    Main Study: FAS population - Sub Study : As Treated
    Units: Participants
        Female
    		 1594 802 2396
        Male
    		 1866 935 2801
    Ethnicity
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        Hispanic or Latino
    		 539 215 754
        Not Hispanic or Latino
    		 2731 1412 4143
        Not reported
    		 116 72 188
        Unknown
    		 74 38 112
    Race
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        White
    		 2545 1249 3794
        Black or African American
    		 597 302 899
        Asian
    		 110 60 170
        American Indian or Alaska Native
    		 19 10 29
        Native Hawaiian or Other Pacific Islander
    		 4 4 8
        Not reported
    		 89 56 145
        Unknown
    		 79 42 121
        Multiple
    		 15 12 27
        Missing
    		 2 2 4
    SARS-CoV-2 status at baseline
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        Positive
    		 19 6 25
        Negative
    		 3316 1665 4981
        Missing
    		 125 66 191
    Region
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        North America
    		 2487 1232 3719
        United Kingdom
    		 611 312 923
        European Union
    		 362 193 555
    Any COVID-19 comorbidities at baseline
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        Yes
    		 2342 1206 3548
        Missing
    		 1118 531 1649
    Any high risk for severe COVID-19 at baseline
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        Yes
    		 2674 1366 4040
        Missing
    		 786 371 1157
    Height
    Main Study: FAS population - Sub Study : As Treated
    Units: cm
        arithmetic mean (standard deviation)
    		 170.04 ( 10.104 ) 170.17 ( 9.840 ) -
    Baseline BMI
    Main Study: FAS population - Sub Study : As Treated
    Units: kg/m**2
        arithmetic mean (standard deviation)
    		 29.57 ( 6.878 ) 29.62 ( 6.984 ) -
    Age Continuous
    Main Study: FAS population - Sub Study : As Treated
    Units: Years
        median (full range (min-max))
    		 57 (18 to 98) 57 (18 to 99) -
    Subject analysis sets

    Subject analysis set title
    Group 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    2 doses of AZD7442 300mg, 10-14 months schedule

    Subject analysis set title
    Group 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    2 doses ofAZD7442 300mg, 6 month schedule

    Subject analysis set title
    Group 3a
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    2 doses of AZD7442 300mg, 10-14 months schedule + 2 doses of AZD7442 600mg, 6 month schedule

    Subject analysis set title
    Group 3b
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    1 dose of AZD7442 300mg, 6 month schedule + 2 doses of AZD7442 600mg, 6 month schedule

    Subject analysis sets values
    		 Group 1 Group 2 Group 3a Group 3b
    Number of subjects
    234
    119
    76
    74
    Age Categorical
    For the Main Study FAS population is considered
    Units: Participants
        >= 18 - < 65 years
    145
    72
    60
    53
        >= 65 - < 85 years
    89
    47
    15
    20
        >= 85 years
    0
    0
    1
    1
    Age Continuous
    Main Study: FAS population - Sub Study : As Treated
    Units: years
        arithmetic mean (standard deviation)
    60.73 ( 11.63 )
    60.62 ( 11.56 )
    59.29 ( 11.61 )
    59.00 ( 11.39 )
    Sex: Female, Male
    Main Study: FAS population - Sub Study : As Treated
    Units: Participants
        Female
    113
    48
    33
    35
        Male
    121
    71
    43
    39
    Ethnicity
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        Hispanic or Latino
    31
    6
    9
    12
        Not Hispanic or Latino
    192
    109
    61
    56
        Not reported
    9
    3
    4
    4
        Unknown
    2
    1
    2
    2
    Race
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        White
    204
    106
    52
    53
        Black or African American
    20
    11
    14
    14
        Asian
    4
    1
    6
    1
        American Indian or Alaska Native
    0
    0
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
    0
    0
        Not reported
    2
    0
    0
    1
        Unknown
    4
    1
    4
    3
        Multiple
    0
    0
    0
    2
        Missing
    0
    0
    0
    0
    SARS-CoV-2 status at baseline
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        Positive
    0
    1
    0
    1
        Negative
    229
    114
    75
    70
        Missing
    5
    4
    1
    3
    Region
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        North America
    130
    75
    76
    74
        United Kingdom
    77
    27
    0
    0
        European Union
    27
    17
    0
    0
    Any COVID-19 comorbidities at baseline
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        Yes
    192
    97
    66
    68
        Missing
    42
    22
    10
    6
    Any high risk for severe COVID-19 at baseline
    Main Study: FAS population - Sub Study : As Treated
    Units: Subjects
        Yes
    209
    107
    69
    73
        Missing
    25
    12
    7
    1
    Height
    Main Study: FAS population - Sub Study : As Treated
    Units: cm
        arithmetic mean (standard deviation)
    170.03 ( 10.29 )
    171.25 ( 10.06 )
    169.03 ( 9.76 )
    168.72 ( 10.27 )
    Baseline BMI
    Main Study: FAS population - Sub Study : As Treated
    Units: kg/m**2
        arithmetic mean (standard deviation)
    29.44 ( 6.21 )
    29.21 ( 6.44 )
    29.24 ( 6.61 )
    31.65 ( 6.75 )
    Age Continuous
    Main Study: FAS population - Sub Study : As Treated
    Units: Years
        median (full range (min-max))
    62 (21 to 84)
    62 (23 to 82)
    60.5 (22 to 86)
    61 (30 to 92)

    End points

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    End points reporting groups
    Reporting group title
    AZD7442
    Reporting group description
    		 300 mg (AZD8895 and AZD1061)

    Reporting group title
    Placebo
    Reporting group description
    		 Saline Placebo
    Reporting group title
    Group1
    Reporting group description
    		 2 doses of AZD7442 300mg, 10-14 months schedule

    Reporting group title
    Group 2
    Reporting group description
    		 2 doses ofAZD7442 300mg, 6 month schedule

    Reporting group title
    Group 3a
    Reporting group description
    		 2 doses of AZD7442 300mg, 10-14 months schedule + 2 doses of AZD7442 600mg, 6 month schedule;

    Reporting group title
    Group 3b
    Reporting group description
    		 1 dose of AZD7442 300mg, 6 month schedule + 2 doses of AZD7442 600mg, 6 month schedule

    Subject analysis set title
    Group 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    2 doses of AZD7442 300mg, 10-14 months schedule

    Subject analysis set title
    Group 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    2 doses ofAZD7442 300mg, 6 month schedule

    Subject analysis set title
    Group 3a
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    2 doses of AZD7442 300mg, 10-14 months schedule + 2 doses of AZD7442 600mg, 6 month schedule

    Subject analysis set title
    Group 3b
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    1 dose of AZD7442 300mg, 6 month schedule + 2 doses of AZD7442 600mg, 6 month schedule

    Primary: Number of Participants with First case of SARS-CoV-2 RT-PCR-positive symptomatic illness

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    End point title
    		 Number of Participants with First case of SARS-CoV-2 RT-PCR-positive symptomatic illness
    End point description
    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 prior to Day 183. Planned to be evaluated through Day 183, however, the number of events required for the primary endpoint was achieved 165 days after the study start date which is displayed in the primary efficacy row below. Final analysis is final data from the study based on the pre-planned 183 days of follow up for this endpoint.
    End point type
    Primary
    End point timeframe
    165 Days for primary analysis, 183 days for final analysis
    End point values
    		 AZD7442 Placebo
    Number of subjects analysed
    3441
    1731
    Units: Participants
        Primary Analysis
    8
    17
        Final Analysis
    12
    34
    Statistical analysis title
    		 Poisson Regression Model
    Statistical analysis description
    Primary Analysis
    Comparison groups
    AZD7442 v Placebo
    Number of subjects included in analysis
    5172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Poisson regression
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    76.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 46.05
         upper limit
    		 89.96
    Statistical analysis title
    		 Poisson Regression Model
    Statistical analysis description
    Final Analysis
    Comparison groups
    AZD7442 v Placebo
    Number of subjects included in analysis
    5172
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Poisson regression
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    83.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 67.26
         upper limit
    		 91.21

    Secondary: The incidence of participants who have a post-treatment response (negative at baseline to positive at any time post-baseline) for SARS-CoV-2 nucleocapsid antibodies.

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    End point title
    		 The incidence of participants who have a post-treatment response (negative at baseline to positive at any time post-baseline) for SARS-CoV-2 nucleocapsid antibodies.
    End point description
    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection
    End point type
    Secondary
    End point timeframe
    366 days
    End point values
    		 AZD7442 Placebo
    Number of subjects analysed
    3121
    1563
    Units: Participants
        SARS-CoV-2 Nucleocapsid Antibodies positive
    198
    139
    Statistical analysis title
    		 Poisson Regression Model
    Comparison groups
    AZD7442 v Placebo
    Number of subjects included in analysis
    4684
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Poisson regression
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    34.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.44
         upper limit
    		 46.05

    Secondary: Incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP up to 366 days

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    End point title
    		 Incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring after dosing with IMP up to 366 days
    End point description
    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19
    End point type
    Secondary
    End point timeframe
    366 Days
    End point values
    		 AZD7442 Placebo
    Number of subjects analysed
    3441
    1731
    Units: Participants
        Incidence
    2
    11
    Statistical analysis title
    		 Poisson Regression Model
    Comparison groups
    AZD7442 v Placebo
    Number of subjects included in analysis
    5172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Poisson regression
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    91.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 61.31
         upper limit
    		 98.09

    Secondary: The incidence of COVID-19-related Emergency Department visits occurring after dosing with IMP by Day 366

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    End point title
    		 The incidence of COVID-19-related Emergency Department visits occurring after dosing with IMP by Day 366
    End point description
    To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits
    End point type
    Secondary
    End point timeframe
    366 days
    End point values
    		 AZD7442 Placebo
    Number of subjects analysed
    3441
    1731
    Units: Participants
        Incidence
    8
    8
    Statistical analysis title
    		 Poisson Regression Model
    Comparison groups
    AZD7442 v Placebo
    Number of subjects included in analysis
    5172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.137
    Method
    		 Poisson regression
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    52.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.61
         upper limit
    		 82.13

    Secondary: Serum AZD7442 concentrations, PK parameters if data permit.

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    End point title
    		 Serum AZD7442 concentrations, PK parameters if data permit. [1]
    End point description
    To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM
    End point type
    Secondary
    End point timeframe
    457 days
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK evaluation was done only for the AZD7442 treatment group.
    End point values
    		 AZD7442
    Number of subjects analysed
    3290
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Day 8
    18.667 ( 92.947 )
        Day 29
    22.602 ( 64.691 )
        Day 58
    18.707 ( 65.981 )
        Day 92
    14.037 ( 67.922 )
        Day 183
    5.593 ( 83.580 )
        Day 366
    1.340 ( 90.132 )
        Day 457
    0.565 ( 85.733 )
    No statistical analyses for this end point

    Secondary: Incidence of ADA to AZD7442 in serum

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    End point title
    		 Incidence of ADA to AZD7442 in serum
    End point description
    To evaluate ADA responses to AZD7442 in serum
    End point type
    Secondary
    End point timeframe
    457 days
    End point values
    		 AZD7442 Placebo
    Number of subjects analysed
    3086
    1540
    Units: Participants
        TE-ADA positive (ADA Incidence)
    403
    34
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    AZD7442
    Reporting group description
    		 -

    Reporting group title
    Group 2
    Reporting group description
    		 -

    Reporting group title
    Group 1
    Reporting group description
    		 -

    Reporting group title
    Group 3b
    Reporting group description
    		 -

    Reporting group title
    Group 3a
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo AZD7442 Group 2 Group 1 Group 3b Group 3a
    Total subjects affected by serious adverse events
         subjects affected / exposed
    97 / 1736 (5.59%)
    215 / 3461 (6.21%)
    20 / 119 (16.81%)
    31 / 234 (13.25%)
    12 / 74 (16.22%)
    12 / 76 (15.79%)
         number of deaths (all causes)
    10
    22
    5
    8
    1
    0
         number of deaths resulting from adverse events
    10
    22
    5
    8
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal cell carcinoma
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal gland cancer metastatic
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma recurrent
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    External ear neoplasm malignant
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer metastatic
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma recurrent
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma recurrent
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary renal cell carcinoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer stage IV
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma stage III
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 1736 (0.00%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Secondary hypertension
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Withdrawal of life support
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Sexual abuse
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 1736 (0.17%)
    3 / 3461 (0.09%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 1736 (0.12%)
    5 / 3461 (0.14%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory alkalosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric decompensation
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device deposit issue
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallbladder obstruction
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Troponin increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia, obstructive
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal dialysis complication
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Second degree chemical burn of skin
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital cystic kidney disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardiac disorders
    Acute left ventricular failure
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    3 / 1736 (0.17%)
    8 / 3461 (0.23%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Paroxysmal atrioventricular block
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 1736 (0.06%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 1736 (0.00%)
    6 / 3461 (0.17%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomegaly
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complex regional pain syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bell's palsy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral venous sinus thrombosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Simple partial seizures
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia of chronic disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Inner ear disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallstone ileus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    3 / 1736 (0.17%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overflow diarrhoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland mass
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    2 / 74 (2.70%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvi-ureteric obstruction
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcapsular renal haematoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Thyrotoxic crisis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint instability
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 1736 (0.00%)
    7 / 3461 (0.20%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous graft site infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extradural abscess
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incision site cellulitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis streptococcal
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal bacteraemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 1736 (0.00%)
    7 / 3461 (0.20%)
    3 / 119 (2.52%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
    0 / 3
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Secondary syphilis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    20 / 1736 (1.15%)
    4 / 3461 (0.12%)
    3 / 119 (2.52%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 4
    0 / 3
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    6 / 1736 (0.35%)
    2 / 3461 (0.06%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes with hyperosmolarity
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholic ketoacidosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo AZD7442 Group 2 Group 1 Group 3b Group 3a
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    993 / 1736 (57.20%)
    1988 / 3461 (57.44%)
    94 / 119 (78.99%)
    185 / 234 (79.06%)
    55 / 74 (74.32%)
    58 / 76 (76.32%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Basal cell carcinoma
         subjects affected / exposed
    5 / 1736 (0.29%)
    8 / 3461 (0.23%)
    2 / 119 (1.68%)
    5 / 234 (2.14%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    8
    2
    6
    0
    0
    Malignant melanoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    Benign neoplasm of skin
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    2
    0
    Blepharal papilloma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Eyelid tumour
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lipoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    5
    0
    1
    0
    1
    Benign breast neoplasm
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Melanocytic naevus
         subjects affected / exposed
    1 / 1736 (0.06%)
    8 / 3461 (0.23%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    8
    0
    2
    0
    0
    Prostate cancer
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    3 / 1736 (0.17%)
    8 / 3461 (0.23%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    8
    0
    3
    0
    0
    Skin papilloma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Myeloproliferative neoplasm
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Abdominal wall neoplasm
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Benign hepatic neoplasm
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Benign salivary gland neoplasm
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Bowen's disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cancer fatigue
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Colon adenoma
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Colon cancer
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Essential thrombocythaemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Fibroma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Haemangioma
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Haemangioma of bone
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hair follicle tumour benign
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Dysplastic naevus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Neoplasm malignant
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Neoplasm skin
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Leiomyoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lung carcinoma cell type unspecified recurrent
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lung neoplasm
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nasal cavity cancer
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Meningioma
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Metastases to liver
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Metastases to lymph nodes
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Naevus haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Malignant neoplasm of eyelid
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Papilloma
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Plasma cell myeloma recurrent
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Salivary gland cancer
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin cancer
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    3
    1
    0
    0
    Thyroid cancer
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Tongue neoplasm benign
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Tumour pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Spinal cord neoplasm
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Vascular disorders
    Arteriovenous fistula
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Deep vein thrombosis
         subjects affected / exposed
    3 / 1736 (0.17%)
    8 / 3461 (0.23%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    9
    1
    1
    0
    0
    Essential hypertension
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    5
    0
    0
    0
    0
    Arteriosclerosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    Aortic dilatation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Flushing
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    0
    1
    0
    Hot flush
         subjects affected / exposed
    2 / 1736 (0.12%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    10
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    56 / 1736 (3.23%)
    99 / 3461 (2.86%)
    7 / 119 (5.88%)
    12 / 234 (5.13%)
    6 / 74 (8.11%)
    8 / 76 (10.53%)
         occurrences all number
    60
    102
    9
    12
    6
    9
    Hypotension
         subjects affected / exposed
    5 / 1736 (0.29%)
    10 / 3461 (0.29%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    5
    10
    1
    1
    1
    0
    Venous thrombosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Phlebitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Thrombophlebitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Varicose vein
         subjects affected / exposed
    1 / 1736 (0.06%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    1
    6
    0
    1
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    White coat hypertension
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Angiodysplasia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Aortic aneurysm
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Aortic arteriosclerosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    Aortic stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Blood pressure fluctuation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Blood pressure inadequately controlled
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Circulatory collapse
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypertensive emergency
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypertensive urgency
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Intermittent claudication
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Lymphoedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Neurogenic shock
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypertensive crisis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Peripheral venous disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    0
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Subclavian vein thrombosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Thrombosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Vascular pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Haemorrhage in pregnancy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    14 / 1736 (0.81%)
    19 / 3461 (0.55%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    14
    20
    1
    2
    1
    1
    Axillary pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Chest discomfort
         subjects affected / exposed
    7 / 1736 (0.40%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    8
    10
    0
    2
    0
    0
    Fatigue
         subjects affected / exposed
    166 / 1736 (9.56%)
    369 / 3461 (10.66%)
    33 / 119 (27.73%)
    54 / 234 (23.08%)
    6 / 74 (8.11%)
    11 / 76 (14.47%)
         occurrences all number
    201
    439
    49
    68
    6
    14
    Chills
         subjects affected / exposed
    72 / 1736 (4.15%)
    155 / 3461 (4.48%)
    17 / 119 (14.29%)
    21 / 234 (8.97%)
    5 / 74 (6.76%)
    6 / 76 (7.89%)
         occurrences all number
    79
    169
    22
    22
    5
    7
    Chronic fatigue syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Energy increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    6
    0
    0
    0
    0
    Facial discomfort
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Chest pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    9 / 3461 (0.26%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    9
    1
    0
    0
    0
    Feeling cold
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Feeling hot
         subjects affected / exposed
    3 / 1736 (0.17%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    2
    0
    0
    0
    0
    Feeling jittery
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Inflammation
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    14 / 1736 (0.81%)
    27 / 3461 (0.78%)
    4 / 119 (3.36%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    16
    29
    11
    3
    0
    1
    Injection site bruising
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Injection site discomfort
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Injection site erythema
         subjects affected / exposed
    2 / 1736 (0.12%)
    8 / 3461 (0.23%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    9
    0
    0
    0
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Injection site haemorrhage
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Injection site induration
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    Injection site joint pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injection site mass
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Injection site oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    19 / 1736 (1.09%)
    37 / 3461 (1.07%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    4 / 76 (5.26%)
         occurrences all number
    20
    39
    1
    1
    0
    5
    Injection site paraesthesia
         subjects affected / exposed
    4 / 1736 (0.23%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    3
    0
    0
    0
    0
    Injection site pruritus
         subjects affected / exposed
    2 / 1736 (0.12%)
    9 / 3461 (0.26%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    9
    1
    0
    0
    0
    Malaise
         subjects affected / exposed
    10 / 1736 (0.58%)
    46 / 3461 (1.33%)
    4 / 119 (3.36%)
    8 / 234 (3.42%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    10
    46
    4
    8
    0
    1
    Injection site reaction
         subjects affected / exposed
    4 / 1736 (0.23%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    7
    0
    0
    0
    0
    Injection site swelling
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    1
    0
    0
    0
    Injection site urticaria
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Injection site warmth
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Injury associated with device
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injection site rash
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Medical device site irritation
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    6 / 1736 (0.35%)
    14 / 3461 (0.40%)
    3 / 119 (2.52%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    14
    3
    2
    0
    0
    Oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    8 / 1736 (0.46%)
    17 / 3461 (0.49%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    9
    18
    1
    1
    1
    0
    Pain
         subjects affected / exposed
    79 / 1736 (4.55%)
    185 / 3461 (5.35%)
    19 / 119 (15.97%)
    25 / 234 (10.68%)
    5 / 74 (6.76%)
    8 / 76 (10.53%)
         occurrences all number
    82
    212
    20
    30
    5
    9
    Vaccination site erythema
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    77 / 1736 (4.44%)
    150 / 3461 (4.33%)
    15 / 119 (12.61%)
    23 / 234 (9.83%)
    5 / 74 (6.76%)
    6 / 76 (7.89%)
         occurrences all number
    84
    158
    17
    28
    5
    7
    Sensation of foreign body
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Swelling face
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    1
    0
    0
    0
    Vaccination site discomfort
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    10 / 1736 (0.58%)
    15 / 3461 (0.43%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    10
    16
    0
    2
    1
    0
    Vessel puncture site haematoma
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vaccination site mass
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vaccination site pain
         subjects affected / exposed
    4 / 1736 (0.23%)
    8 / 3461 (0.23%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    8
    0
    0
    0
    0
    Vaccination site reaction
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    0
    1
    0
    0
    Feeling abnormal
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Catheter site swelling
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Crepitations
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Cyst
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Facial pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Adverse drug reaction
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Foaming at mouth
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Gait disturbance
         subjects affected / exposed
    3 / 1736 (0.17%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    3
    1
    1
    0
    0
    Generalised oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hangover
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hernia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Mass
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Puncture site pruritus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Retention cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Secretion discharge
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Swelling
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Puncture site oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    3 / 1736 (0.17%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    6
    0
    3
    0
    0
    Allergy to chemicals
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypersensitivity
         subjects affected / exposed
    4 / 1736 (0.23%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    1
    0
    1
    0
    0
    Seasonal allergy
         subjects affected / exposed
    11 / 1736 (0.63%)
    29 / 3461 (0.84%)
    2 / 119 (1.68%)
    4 / 234 (1.71%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    11
    29
    2
    5
    1
    0
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Allergy to plants
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Food allergy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Primary amyloidosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Sarcoidosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Mite allergy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Social circumstances
    Physical abuse
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Physical assault
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Alcohol use
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Menopause
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Reproductive system and breast disorders
    Breast cyst
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Abnormal uterine bleeding
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 1736 (0.06%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    2 / 74 (2.70%)
    1 / 76 (1.32%)
         occurrences all number
    1
    9
    0
    1
    2
    1
    Breast mass
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Breast swelling
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Ejaculation failure
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    1
    0
    0
    Intermenstrual bleeding
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Menometrorrhagia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Menopausal disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Menopausal symptoms
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    Pelvic adhesions
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    Perineal pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Polycystic ovaries
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Priapism
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Prostatitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Uterine polyp
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    Vulva cyst
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Vulvovaginal pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Uterine prolapse
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Balanoposthitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Adenomyosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Atrophic vulvovaginitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    0
    Bartholin's cyst
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Breast calcifications
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Breast enlargement
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Breast pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Cervical dysplasia
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Cervix inflammation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oligomenorrhoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Epididymal cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Fibrocystic breast disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gynaecomastia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Menstruation irregular
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Nipple pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Ovarian cyst
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Pelvic congestion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Peyronie's disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Postmenopausal haemorrhage
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Premenstrual syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Prostatomegaly
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    0
    Testicular cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Testicular pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Urogenital atrophy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vaginal cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vaginal prolapse
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Varicocele
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vulvovaginal inflammation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    8 / 1736 (0.46%)
    19 / 3461 (0.55%)
    1 / 119 (0.84%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    9
    22
    1
    3
    0
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    8 / 1736 (0.46%)
    19 / 3461 (0.55%)
    2 / 119 (1.68%)
    4 / 234 (1.71%)
    2 / 74 (2.70%)
    1 / 76 (1.32%)
         occurrences all number
    14
    22
    3
    4
    2
    1
    Choking
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Bronchospasm
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Bronchitis chronic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Bronchiectasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    0
    Atelectasis
         subjects affected / exposed
    3 / 1736 (0.17%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    3
    4
    1
    0
    0
    2
    Cough
         subjects affected / exposed
    179 / 1736 (10.31%)
    423 / 3461 (12.22%)
    36 / 119 (30.25%)
    68 / 234 (29.06%)
    10 / 74 (13.51%)
    14 / 76 (18.42%)
         occurrences all number
    213
    517
    58
    88
    10
    21
    Dry throat
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Dysphonia
         subjects affected / exposed
    4 / 1736 (0.23%)
    8 / 3461 (0.23%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    4
    8
    0
    2
    0
    1
    Dyspnoea
         subjects affected / exposed
    67 / 1736 (3.86%)
    162 / 3461 (4.68%)
    18 / 119 (15.13%)
    26 / 234 (11.11%)
    4 / 74 (5.41%)
    5 / 76 (6.58%)
         occurrences all number
    92
    225
    29
    43
    6
    7
    Dyspnoea exertional
         subjects affected / exposed
    2 / 1736 (0.12%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    10
    0
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    6 / 1736 (0.35%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    6
    8
    0
    3
    0
    1
    Haemoptysis
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Hypoxia
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    2
    3
    0
    1
    0
    2
    Nasal obstruction
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Nasal discomfort
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    114 / 1736 (6.57%)
    283 / 3461 (8.18%)
    26 / 119 (21.85%)
    42 / 234 (17.95%)
    8 / 74 (10.81%)
    11 / 76 (14.47%)
         occurrences all number
    128
    320
    34
    52
    9
    11
    Nasal cavity mass
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lower respiratory tract congestion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nasal pruritus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    1
    0
    0
    Pharyngeal erythema
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    Pharyngeal swelling
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    3
    0
    0
    Pleurisy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    Productive cough
         subjects affected / exposed
    9 / 1736 (0.52%)
    19 / 3461 (0.55%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    10
    19
    2
    2
    0
    0
    Oropharyngeal discomfort
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    117 / 1736 (6.74%)
    305 / 3461 (8.81%)
    21 / 119 (17.65%)
    47 / 234 (20.09%)
    7 / 74 (9.46%)
    9 / 76 (11.84%)
         occurrences all number
    134
    357
    34
    56
    9
    12
    Rhinitis allergic
         subjects affected / exposed
    5 / 1736 (0.29%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    5
    10
    0
    0
    1
    0
    Respiratory tract congestion
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    Pulmonary mass
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    1
    3
    1
    0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    2 / 1736 (0.12%)
    5 / 3461 (0.14%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    5
    1
    0
    0
    0
    Pulmonary congestion
         subjects affected / exposed
    8 / 1736 (0.46%)
    25 / 3461 (0.72%)
    3 / 119 (2.52%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    8
    26
    4
    0
    1
    2
    Rhinorrhoea
         subjects affected / exposed
    124 / 1736 (7.14%)
    316 / 3461 (9.13%)
    29 / 119 (24.37%)
    43 / 234 (18.38%)
    6 / 74 (8.11%)
    8 / 76 (10.53%)
         occurrences all number
    141
    363
    40
    54
    6
    14
    Sinonasal obstruction
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    15 / 1736 (0.86%)
    38 / 3461 (1.10%)
    2 / 119 (1.68%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    20
    45
    2
    0
    1
    0
    Sinus pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    4 / 1736 (0.23%)
    5 / 3461 (0.14%)
    3 / 119 (2.52%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    5
    3
    0
    0
    0
    Sneezing
         subjects affected / exposed
    11 / 1736 (0.63%)
    21 / 3461 (0.61%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    11
    24
    2
    2
    0
    0
    Suffocation feeling
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    7
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    9 / 1736 (0.52%)
    15 / 3461 (0.43%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    9
    16
    0
    2
    0
    0
    Vasomotor rhinitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Acute respiratory failure
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    1
    0
    0
    0
    Allergic bronchitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Aspiration
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Increased viscosity of bronchial secretion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Asthmatic crisis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Catarrh
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Emphysema
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    2
    4
    0
    0
    0
    1
    Hiccups
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Increased bronchial secretion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Asthma exercise induced
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Laryngeal leukoplakia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Laryngeal oedema
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Laryngitis allergic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lung consolidation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Lung disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oropharyngeal plaque
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nasal oedema
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nasal septum deviation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Nasal turbinate hypertrophy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nasal ulcer
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nasal inflammation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Orthopnoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pharyngeal hypertrophy
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Pleuritic pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Pneumonitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Pulmonary artery dilatation
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Respiratory distress
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pulmonary oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pulmonary toxicity
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Rales
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Reflux laryngitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    0
    Respiratory arrest
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Respiratory failure
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Respiratory gas exchange disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Rhonchi
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Sputum discoloured
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Tachypnoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Throat tightness
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tracheal disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    1
    0
    Vocal cord polyp
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tonsillar erythema
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    11 / 1736 (0.63%)
    34 / 3461 (0.98%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    11
    36
    2
    2
    1
    2
    Abnormal dreams
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Aggression
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Anxiety disorder
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    0
    Confusional state
         subjects affected / exposed
    9 / 1736 (0.52%)
    15 / 3461 (0.43%)
    2 / 119 (1.68%)
    4 / 234 (1.71%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    9
    15
    2
    5
    0
    0
    Depressed mood
         subjects affected / exposed
    4 / 1736 (0.23%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    7
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    8 / 1736 (0.46%)
    22 / 3461 (0.64%)
    3 / 119 (2.52%)
    2 / 234 (0.85%)
    3 / 74 (4.05%)
    0 / 76 (0.00%)
         occurrences all number
    8
    22
    3
    2
    3
    0
    Obsessive-compulsive disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Euphoric mood
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    14 / 1736 (0.81%)
    21 / 3461 (0.61%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    14
    22
    1
    1
    0
    0
    Irritability
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nightmare
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Disorientation
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Restlessness
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Somatic symptom disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Stress
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Suicidal ideation
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    3 / 1736 (0.17%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    7
    0
    1
    0
    0
    Autism spectrum disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Anger
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Alcoholism
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Alcohol abuse
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Agitation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Bipolar disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Borderline personality disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Claustrophobia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Drug abuse
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Drug use disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Acute stress disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Generalised anxiety disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Grief reaction
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hallucination
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hallucinations, mixed
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Mania
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Mental status changes
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nervousness
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Panic disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Persistent complex bereavement disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Rapid eye movement sleep behaviour disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Sleep terror
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Product issues
    Device malfunction
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Device occlusion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Device loosening
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Device breakage
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Device physical property issue
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cholecystitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Cholelithiasis
         subjects affected / exposed
    5 / 1736 (0.29%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    5
    7
    0
    0
    0
    2
    Hepatic steatosis
         subjects affected / exposed
    7 / 1736 (0.40%)
    11 / 3461 (0.32%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    7
    11
    2
    2
    0
    1
    Nonalcoholic fatty liver disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Hepatic fibrosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Bile duct stone
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    Biliary dyskinesia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Biliary obstruction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Hepatic cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hepatic cytolysis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hepatobiliary cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hepatosplenomegaly
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hyperplastic cholecystopathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    6
    0
    1
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 1736 (0.23%)
    8 / 3461 (0.23%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    8
    1
    0
    0
    0
    Bacterial test positive
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    17 / 1736 (0.98%)
    24 / 3461 (0.69%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    17
    24
    0
    1
    2
    0
    Blood cholesterol increased
         subjects affected / exposed
    3 / 1736 (0.17%)
    9 / 3461 (0.26%)
    2 / 119 (1.68%)
    5 / 234 (2.14%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    3
    9
    2
    5
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    2 / 1736 (0.12%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    2
    6
    0
    0
    1
    0
    Blood glucose fluctuation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood glucose increased
         subjects affected / exposed
    9 / 1736 (0.52%)
    17 / 3461 (0.49%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    9
    17
    1
    1
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    Blood potassium increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Blood pressure diastolic increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    8 / 1736 (0.46%)
    16 / 3461 (0.46%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    8
    16
    0
    3
    1
    0
    Blood pressure systolic increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Blood testosterone decreased
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    Blood urea increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood urine present
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Blood uric acid increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    9 / 1736 (0.52%)
    16 / 3461 (0.46%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    9
    16
    2
    1
    0
    0
    Coagulation test abnormal
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Cardiac murmur
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    1
    0
    1
    0
    Cortisol decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 1736 (0.12%)
    12 / 3461 (0.35%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    12
    1
    1
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Heart rate increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    9 / 1736 (0.52%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    9
    6
    0
    1
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    2 / 1736 (0.12%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    5
    0
    0
    0
    0
    International normalised ratio abnormal
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Liver function test abnormal
         subjects affected / exposed
    1 / 1736 (0.06%)
    6 / 3461 (0.17%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    6
    1
    0
    0
    0
    Liver function test increased
         subjects affected / exposed
    8 / 1736 (0.46%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    8
    9
    0
    0
    0
    0
    Monocyte count increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Mean cell volume decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Platelet count increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    0
    Protein urine present
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Prothrombin level increased
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    Red blood cell count increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Red blood cells urine positive
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Smear cervix abnormal
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Serum ferritin decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Reticulocyte count decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Respiratory rate decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    3 / 1736 (0.17%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    2
    0
    0
    0
    0
    Troponin increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    3
    0
    0
    Urine analysis abnormal
         subjects affected / exposed
    4 / 1736 (0.23%)
    8 / 3461 (0.23%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    8
    0
    1
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    White blood cell count increased
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    White blood cells urine positive
         subjects affected / exposed
    5 / 1736 (0.29%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    11
    0
    0
    0
    0
    Aortic bruit
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Blood calcium increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood folate decreased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Alanine aminotransferase abnormal
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood sodium increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Coagulation factor increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Chlamydia test positive
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Carbohydrate antigen 19-9 increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Brain natriuretic peptide increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood thrombin increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    3 / 74 (4.05%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    3
    3
    0
    Blood glucose abnormal
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Blood iron decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Body temperature decreased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Low density lipoprotein increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Lipids increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Laboratory test abnormal
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Haematocrit increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Glucose urine present
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Gamma-glutamyltransferase abnormal
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Culture urine positive
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Crystal urine present
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Mycoplasma test positive
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Creatinine renal clearance increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Norovirus test positive
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Neisseria test positive
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    3 / 1736 (0.17%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    3
    1
    0
    2
    1
    0
    Urine output decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Urinary casts
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Transferrin saturation increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Streptococcus test positive
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Reticulocyte count increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Respiratory rate increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    White blood cells urine
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    HIV test positive
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    4 / 74 (5.41%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    1
    2
    4
    0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Electrocardiogram T wave amplitude decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    2
    0
    0
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Electrocardiogram P wave biphasic
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    ECG signs of ventricular hypertrophy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Coagulation factor VIII level increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Blood HIV RNA increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Anti factor VIII antibody increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Vitamin B12 decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Vitamin B1 decreased
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Troponin I increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    0
    0
    1
    2
    0
    2
    Thrombin-antithrombin III complex increased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    2 / 74 (2.70%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    1
    3
    2
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    QRS axis abnormal
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Vitamin D decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Anaesthetic complication
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Abdominal injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Animal bite
         subjects affected / exposed
    4 / 1736 (0.23%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    2
    0
    0
    0
    0
    Arteriovenous fistula site complication
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    2 / 1736 (0.12%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    10
    0
    1
    0
    0
    Arthropod sting
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Back injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Complications of transplant surgery
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cartilage injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Chest injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    Arteriovenous fistula aneurysm
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Ankle fracture
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Bone contusion
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Contusion
         subjects affected / exposed
    4 / 1736 (0.23%)
    22 / 3461 (0.64%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    4
    24
    2
    2
    1
    0
    Epicondylitis
         subjects affected / exposed
    4 / 1736 (0.23%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    6
    0
    1
    0
    0
    Eyelid contusion
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Face injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Foreign body in eye
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Femur fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Foot fracture
         subjects affected / exposed
    3 / 1736 (0.17%)
    15 / 3461 (0.43%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    3
    15
    1
    2
    1
    0
    Foreign body
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Foreign body in ear
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    17 / 1736 (0.98%)
    44 / 3461 (1.27%)
    7 / 119 (5.88%)
    9 / 234 (3.85%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    17
    44
    7
    9
    1
    0
    Hand fracture
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    1
    0
    0
    0
    Head injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    10
    0
    1
    0
    0
    Hip fracture
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Injection related reaction
         subjects affected / exposed
    6 / 1736 (0.35%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    13
    0
    0
    0
    0
    Joint injury
         subjects affected / exposed
    8 / 1736 (0.46%)
    6 / 3461 (0.17%)
    2 / 119 (1.68%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    8
    6
    2
    0
    0
    0
    Lumbar vertebral fracture
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    6 / 1736 (0.35%)
    18 / 3461 (0.52%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    18
    1
    1
    0
    0
    Limb injury
         subjects affected / exposed
    9 / 1736 (0.52%)
    11 / 3461 (0.32%)
    2 / 119 (1.68%)
    3 / 234 (1.28%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    9
    11
    2
    3
    1
    0
    Lip injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Lower limb fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ligament rupture
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Meniscus injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    0
    1
    0
    0
    Muscle rupture
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    1
    0
    0
    Muscle strain
         subjects affected / exposed
    3 / 1736 (0.17%)
    8 / 3461 (0.23%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    3
    8
    1
    0
    1
    0
    Neck injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Patella fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    2
    4
    0
    2
    0
    2
    Periorbital haematoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Post-traumatic pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    2
    0
    1
    0
    1
    Procedural pain
         subjects affected / exposed
    10 / 1736 (0.58%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    11
    11
    0
    0
    0
    0
    Radius fracture
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    Pelvic bone injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Road traffic accident
         subjects affected / exposed
    4 / 1736 (0.23%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    4
    6
    0
    0
    1
    1
    Skin abrasion
         subjects affected / exposed
    4 / 1736 (0.23%)
    8 / 3461 (0.23%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    4
    10
    1
    0
    0
    2
    Skin laceration
         subjects affected / exposed
    7 / 1736 (0.40%)
    22 / 3461 (0.64%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    7
    25
    0
    1
    0
    0
    Skull fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Splinter
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Upper limb fracture
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    Stress fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tendon rupture
         subjects affected / exposed
    3 / 1736 (0.17%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    3
    0
    0
    0
    0
    Thermal burn
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Tooth fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    7
    0
    0
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vaccination complication
         subjects affected / exposed
    50 / 1736 (2.88%)
    71 / 3461 (2.05%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    81
    132
    0
    1
    0
    0
    Vascular access site haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Wrist fracture
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Chemical burns of eye
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Accident at work
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Alcohol poisoning
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    2
    0
    0
    Arteriovenous fistula occlusion
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Arteriovenous fistula site haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Avulsion fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Barotitis media
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Accident
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Haemodialysis complication
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Heat exhaustion
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Clavicle fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Concussion
         subjects affected / exposed
    3 / 1736 (0.17%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    3
    1
    0
    0
    0
    Corneal abrasion
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Craniocerebral injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Gun shot wound
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Eye injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Facial bones fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Fibula fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Forearm fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Graft complication
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Extradural haematoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Humerus fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Hyphaema
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Incisional hernia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    Joint dislocation
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    1
    0
    0
    0
    Ligament injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Poisoning
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Multiple fractures
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Muscle injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nerve injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Osteochondral fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Overdose
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Median nerve injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Post concussion syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Post procedural complication
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Post procedural constipation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Post procedural diarrhoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Post-traumatic neck syndrome
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Postoperative delirium
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Spinal column injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Radiation pneumonitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Second degree chemical burn of skin
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Seroma
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin injury
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin wound
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Procedural nausea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Stab wound
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Stomal hernia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Subdural haematoma
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tendon injury
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Tibia fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Traumatic ulcer
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ulnar nerve injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Vulvovaginal injury
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Wound
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Arteriovenous malformation
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Thalassaemia beta
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrointestinal arteriovenous malformation
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Dermoid cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Type V hyperlipidaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Angina unstable
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Angina pectoris
         subjects affected / exposed
    4 / 1736 (0.23%)
    10 / 3461 (0.29%)
    3 / 119 (2.52%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    10
    3
    2
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    6 / 1736 (0.35%)
    13 / 3461 (0.38%)
    3 / 119 (2.52%)
    2 / 234 (0.85%)
    2 / 74 (2.70%)
    3 / 76 (3.95%)
         occurrences all number
    6
    13
    3
    2
    2
    3
    Bradycardia
         subjects affected / exposed
    5 / 1736 (0.29%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    4
    1
    0
    0
    0
    Bundle branch block left
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Coronary artery disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    6 / 3461 (0.17%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    0
    6
    1
    2
    1
    2
    Cardiomyopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Palpitations
         subjects affected / exposed
    10 / 1736 (0.58%)
    17 / 3461 (0.49%)
    0 / 119 (0.00%)
    5 / 234 (2.14%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    10
    21
    0
    5
    0
    0
    Left ventricular failure
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Sinus arrhythmia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    5 / 1736 (0.29%)
    11 / 3461 (0.32%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    11
    0
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    2
    2
    1
    0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    3
    1
    2
    0
    1
    Atrial flutter
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Atrial enlargement
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Aortic valve sclerosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Acute left ventricular failure
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cardiac failure acute
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Cardiomegaly
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Chronotropic incompetence
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Diastolic dysfunction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Bundle branch block right
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    2
    0
    0
    Bifascicular block
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Cardiac failure
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Extrasystoles
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Intracardiac thrombus
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Left atrial enlargement
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Myocardial infarction
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Ventricular hypokinesia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ventricular hypertrophy
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Ventricular fibrillation
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    2 / 119 (1.68%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Pericardial effusion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Myocarditis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Myocardial ischaemia
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    35 / 1736 (2.02%)
    63 / 3461 (1.82%)
    5 / 119 (4.20%)
    8 / 234 (3.42%)
    3 / 74 (4.05%)
    1 / 76 (1.32%)
         occurrences all number
    37
    67
    6
    8
    3
    1
    Amnesia
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Anosmia
         subjects affected / exposed
    30 / 1736 (1.73%)
    57 / 3461 (1.65%)
    5 / 119 (4.20%)
    7 / 234 (2.99%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    31
    60
    7
    8
    1
    0
    Aphasia
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Balance disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    0
    Clonus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Bell's palsy
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Burning sensation
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    1
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    6 / 1736 (0.35%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    4
    0
    0
    0
    0
    Dysarthria
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    22 / 1736 (1.27%)
    52 / 3461 (1.50%)
    3 / 119 (2.52%)
    5 / 234 (2.14%)
    3 / 74 (4.05%)
    1 / 76 (1.32%)
         occurrences all number
    28
    56
    5
    5
    3
    1
    Depressed level of consciousness
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Dementia
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    Encephalopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hyposmia
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    4 / 1736 (0.23%)
    13 / 3461 (0.38%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    13
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    211 / 1736 (12.15%)
    439 / 3461 (12.68%)
    33 / 119 (27.73%)
    52 / 234 (22.22%)
    8 / 74 (10.81%)
    7 / 76 (9.21%)
         occurrences all number
    252
    564
    42
    64
    9
    11
    Head discomfort
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Essential tremor
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Intraneural cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed
    5 / 1736 (0.29%)
    7 / 3461 (0.20%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    7
    1
    2
    0
    0
    Loss of consciousness
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    Migraine
         subjects affected / exposed
    8 / 1736 (0.46%)
    24 / 3461 (0.69%)
    2 / 119 (1.68%)
    0 / 234 (0.00%)
    2 / 74 (2.70%)
    0 / 76 (0.00%)
         occurrences all number
    10
    27
    2
    0
    2
    0
    Movement disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Myoclonus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nerve compression
         subjects affected / exposed
    3 / 1736 (0.17%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    3
    0
    2
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    7 / 1736 (0.40%)
    3 / 3461 (0.09%)
    2 / 119 (1.68%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    7
    3
    2
    0
    0
    0
    Ophthalmic migraine
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    10 / 1736 (0.58%)
    17 / 3461 (0.49%)
    2 / 119 (1.68%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    10
    17
    2
    0
    0
    0
    Presyncope
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    3
    0
    1
    0
    1
    Post-traumatic headache
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Parosmia
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    2
    1
    1
    1
    1
    1
    Sciatica
         subjects affected / exposed
    7 / 1736 (0.40%)
    16 / 3461 (0.46%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    8
    17
    2
    2
    0
    0
    Seizure
         subjects affected / exposed
    3 / 1736 (0.17%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    6
    0
    1
    0
    0
    Sinus headache
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Syncope
         subjects affected / exposed
    3 / 1736 (0.17%)
    16 / 3461 (0.46%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    3
    17
    1
    1
    0
    1
    Tension headache
         subjects affected / exposed
    3 / 1736 (0.17%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    2 / 1736 (0.12%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    6
    0
    0
    0
    0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Altered state of consciousness
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    3 / 1736 (0.17%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    1
    0
    1
    0
    0
    Carotid artery thrombosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cerebral infarction
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Cerebral congestion
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Cerebral atrophy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Cerebral artery occlusion
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cerebral arteriosclerosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cerebellar infarction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Central pain syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ataxia
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Axonal neuropathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    0
    Cubital tunnel syndrome
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cranial nerve disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Complex regional pain syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Cognitive disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    5
    0
    1
    0
    0
    Cluster headache
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Diabetic neuropathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Cervicogenic headache
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cerebral microangiopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hypersomnia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hemiparesis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Fine motor skill dysfunction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Facial paresis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dizziness postural
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hypogeusia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Migraine with aura
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Mental impairment
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Leukoencephalopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lacunar infarction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Radiculopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Radicular pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Polyneuropathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Piriformis syndrome
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Muscle contractions involuntary
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Peripheral nerve lesion
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Parkinson's disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Osmotic demyelination syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Normal pressure hydrocephalus
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Myelopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Peroneal nerve palsy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Vascular dementia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Transient global amnesia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Taste disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Spinal claudication
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Speech disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    17 / 1736 (0.98%)
    37 / 3461 (1.07%)
    3 / 119 (2.52%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    17
    37
    3
    1
    1
    2
    Increased tendency to bruise
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    3
    1
    0
    0
    Leukopenia
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Leukocytosis
         subjects affected / exposed
    2 / 1736 (0.12%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    5
    0
    0
    0
    0
    Lymphadenitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    2
    0
    1
    0
    1
    Neutrophilia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    6
    0
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    8 / 1736 (0.46%)
    15 / 3461 (0.43%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    8
    18
    2
    2
    0
    1
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Normocytic anaemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Polycythaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Splenomegaly
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    2
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    3 / 1736 (0.17%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    3
    0
    2
    0
    0
    Febrile neutropenia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Deficiency anaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Coagulopathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Blood loss anaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Anaemia of chronic disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Bone marrow oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hilar lymphadenopathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Hyperleukocytosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypochromic anaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lymph node pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Macrocytosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Microcytic anaemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pancytopenia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    Deafness unilateral
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Cerumen impaction
         subjects affected / exposed
    1 / 1736 (0.06%)
    6 / 3461 (0.17%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    9
    1
    0
    0
    0
    Vertigo
         subjects affected / exposed
    7 / 1736 (0.40%)
    17 / 3461 (0.49%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    9
    20
    0
    3
    0
    0
    Tinnitus
         subjects affected / exposed
    3 / 1736 (0.17%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    3
    7
    0
    1
    0
    1
    Inner ear inflammation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    1
    0
    0
    Ear pain
         subjects affected / exposed
    9 / 1736 (0.52%)
    13 / 3461 (0.38%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    9
    13
    2
    1
    0
    1
    Sudden hearing loss
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Presbyacusis
         subjects affected / exposed
    3 / 1736 (0.17%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    Otorrhoea
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Middle ear effusion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Haematotympanum
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    External ear inflammation
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Excessive cerumen production
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Eustachian tube dysfunction
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Ear congestion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ear canal erythema
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Deafness bilateral
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Superior semicircular canal dehiscence
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Deafness
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vertigo positional
         subjects affected / exposed
    0 / 1736 (0.00%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    5
    0
    1
    0
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Cataract
         subjects affected / exposed
    5 / 1736 (0.29%)
    11 / 3461 (0.32%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    5
    12
    1
    0
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    2
    0
    0
    Dry age-related macular degeneration
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Dry eye
         subjects affected / exposed
    4 / 1736 (0.23%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    9
    0
    0
    0
    0
    Eye allergy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Eye irritation
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Eye pain
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    1
    0
    0
    0
    Eye pruritus
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    0
    Eye swelling
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    6
    0
    1
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    Periorbital oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Periorbital swelling
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Periorbital pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Scleritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Visual impairment
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Age-related macular degeneration
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Asthenopia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Astigmatism
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Chalazion
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Dermatochalasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Erythema of eyelid
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Eye inflammation
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Glaucoma
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Keratitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Macular degeneration
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    2 / 119 (1.68%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    Macular fibrosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Macular oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Myopia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Ocular hypertension
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ophthalmoplegia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Diabetic retinal oedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Vitreous detachment
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Vitreous adhesions
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Visual field defect
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Uveitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Swelling of eyelid
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Orbital oedema
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Retinal detachment
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    2
    0
    0
    Pterygium
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Presbyopia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Posterior capsule opacification
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Photophobia
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Retinal tear
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    7 / 1736 (0.40%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    8
    9
    0
    3
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 1736 (0.06%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    6
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    19 / 1736 (1.09%)
    29 / 3461 (0.84%)
    4 / 119 (3.36%)
    7 / 234 (2.99%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    21
    30
    5
    7
    1
    0
    Abdominal rigidity
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    7 / 1736 (0.40%)
    21 / 3461 (0.61%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    7
    22
    1
    1
    1
    2
    Abdominal pain lower
         subjects affected / exposed
    2 / 1736 (0.12%)
    11 / 3461 (0.32%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    2
    11
    0
    0
    0
    1
    Abdominal tenderness
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Anal polyp
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Change of bowel habit
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    Dental caries
         subjects affected / exposed
    3 / 1736 (0.17%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    6
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    11 / 1736 (0.63%)
    25 / 3461 (0.72%)
    3 / 119 (2.52%)
    5 / 234 (2.14%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    12
    26
    3
    5
    1
    1
    Colitis
         subjects affected / exposed
    4 / 1736 (0.23%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    4
    0
    2
    0
    0
    Diarrhoea
         subjects affected / exposed
    81 / 1736 (4.67%)
    183 / 3461 (5.29%)
    16 / 119 (13.45%)
    23 / 234 (9.83%)
    3 / 74 (4.05%)
    5 / 76 (6.58%)
         occurrences all number
    91
    206
    22
    26
    3
    5
    Dry mouth
         subjects affected / exposed
    5 / 1736 (0.29%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    7
    0
    1
    0
    0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    1
    0
    0
    Diverticulum
         subjects affected / exposed
    0 / 1736 (0.00%)
    11 / 3461 (0.32%)
    3 / 119 (2.52%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    0
    11
    3
    2
    0
    2
    Dyspepsia
         subjects affected / exposed
    7 / 1736 (0.40%)
    13 / 3461 (0.38%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    7
    13
    0
    1
    0
    0
    Dysphagia
         subjects affected / exposed
    1 / 1736 (0.06%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    7
    0
    3
    0
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Food poisoning
         subjects affected / exposed
    4 / 1736 (0.23%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    4
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    4 / 1736 (0.23%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    0
    Faeces soft
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gingival pain
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Gingival disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    14 / 1736 (0.81%)
    28 / 3461 (0.81%)
    5 / 119 (4.20%)
    5 / 234 (2.14%)
    2 / 74 (2.70%)
    1 / 76 (1.32%)
         occurrences all number
    15
    28
    5
    5
    2
    1
    Gastritis
         subjects affected / exposed
    3 / 1736 (0.17%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    2 / 74 (2.70%)
    4 / 76 (5.26%)
         occurrences all number
    3
    10
    0
    1
    2
    4
    Gastrointestinal hypermotility
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    1
    0
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Hyperaesthesia teeth
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 1736 (0.06%)
    9 / 3461 (0.26%)
    1 / 119 (0.84%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    9
    1
    3
    0
    0
    Haemorrhoids
         subjects affected / exposed
    4 / 1736 (0.23%)
    15 / 3461 (0.43%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    4
    15
    0
    1
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    2 / 1736 (0.12%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    8
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    3 / 1736 (0.17%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    4
    1
    0
    0
    0
    Large intestine polyp
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    2
    4
    0
    0
    0
    1
    Oral mucosal blistering
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oral disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    75 / 1736 (4.32%)
    163 / 3461 (4.71%)
    8 / 119 (6.72%)
    14 / 234 (5.98%)
    6 / 74 (8.11%)
    8 / 76 (10.53%)
         occurrences all number
    82
    191
    12
    16
    6
    11
    Mouth ulceration
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    5
    1
    0
    0
    0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lip disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Salivary gland enlargement
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Peptic ulcer
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Pancreatitis
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oral mucosal eruption
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Swollen tongue
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Tongue ulceration
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Tongue disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Tongue discomfort
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Tooth impacted
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    30 / 1736 (1.73%)
    60 / 3461 (1.73%)
    3 / 119 (2.52%)
    10 / 234 (4.27%)
    3 / 74 (4.05%)
    2 / 76 (2.63%)
         occurrences all number
    33
    75
    3
    10
    3
    3
    Toothache
         subjects affected / exposed
    2 / 1736 (0.12%)
    17 / 3461 (0.49%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    2
    18
    0
    0
    0
    1
    Anal fissure
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Abdominal mass
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Anal fistula
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Anal pruritus
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Anal skin tags
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Angular cheilitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Anogenital dysplasia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Chronic gastritis
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    0
    Apical granuloma
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Ascites
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Bile acid malabsorption
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Bowel movement irregularity
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Cheilitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Anorectal disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Colitis ulcerative
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Crohn's disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    Diaphragmatic hernia
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Duodenal ulcer
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Duodenitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Dyskinesia oesophageal
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Colitis microscopic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Eructation
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastric disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Gastric ulcer
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    0
    Coeliac disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Eosinophilic oesophagitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastritis alcoholic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastritis erosive
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Gastrointestinal mucosa hyperaemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Giant cell epulis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Glossitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Glossodynia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Haematemesis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Haemorrhoids thrombosed
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Ileus
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Inflammatory bowel disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Inguinal hernia
         subjects affected / exposed
    3 / 1736 (0.17%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    0
    Inguinal hernia strangulated
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Large intestinal stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Large intestinal ulcer
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Oesophageal motility disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Melaena
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    Oesophageal dilatation
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Oesophageal disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Loose tooth
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oesophageal spasm
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Oesophagitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    1
    0
    0
    Pancreatic failure
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Pancreatic mass
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pancreatic steatosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Salivary gland disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Periodontal disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Plicated tongue
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Proctitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 1736 (0.12%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    5
    0
    0
    0
    0
    Rectal polyp
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pancreatitis chronic
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Salivary gland mucocoele
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Salivary hypersecretion
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Sigmoid mesocolon hernia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Submaxillary gland enlargement
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tongue discolouration
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tongue geographic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tooth disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tooth loss
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Trichoglossia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Umbilical hernia
         subjects affected / exposed
    0 / 1736 (0.00%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    5
    0
    1
    0
    0
    Tongue erythema
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Uvulitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 1736 (0.17%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    7
    0
    0
    0
    0
    Dermal cyst
         subjects affected / exposed
    4 / 1736 (0.23%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    5
    0
    2
    0
    0
    Dermatitis
         subjects affected / exposed
    2 / 1736 (0.12%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    6
    0
    3
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    3 / 1736 (0.17%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    3
    10
    0
    1
    2
    1
    Diabetic wound
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Actinic keratosis
         subjects affected / exposed
    3 / 1736 (0.17%)
    7 / 3461 (0.20%)
    4 / 119 (3.36%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    7
    5
    2
    0
    0
    Angioedema
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Ecchymosis
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    3 / 1736 (0.17%)
    7 / 3461 (0.20%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    7
    1
    2
    0
    0
    Erythema
         subjects affected / exposed
    3 / 1736 (0.17%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    3
    7
    0
    1
    0
    1
    Dry skin
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    0
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    5 / 1736 (0.29%)
    7 / 3461 (0.20%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    7
    1
    1
    0
    0
    Ingrowing nail
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    Intertrigo
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Lichen sclerosus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Night sweats
         subjects affected / exposed
    1 / 1736 (0.06%)
    11 / 3461 (0.32%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    12
    1
    0
    0
    0
    Miliaria
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Macule
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pain of skin
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    13 / 1736 (0.75%)
    21 / 3461 (0.61%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    13
    21
    1
    2
    1
    1
    Pityriasis rosea
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Petechiae
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    2 / 1736 (0.12%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    5
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    22 / 1736 (1.27%)
    41 / 3461 (1.18%)
    3 / 119 (2.52%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    22
    46
    4
    0
    1
    3
    Rash erythematous
         subjects affected / exposed
    3 / 1736 (0.17%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    Rash papular
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Skin exfoliation
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    3 / 1736 (0.17%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    4
    0
    1
    0
    0
    Skin lesion
         subjects affected / exposed
    8 / 1736 (0.46%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    9
    5
    1
    1
    0
    0
    Urticaria
         subjects affected / exposed
    5 / 1736 (0.29%)
    11 / 3461 (0.32%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    12
    0
    1
    0
    0
    Skin ulcer
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    0
    Skin striae
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Alopecia
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Blister
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    Cold sweat
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Decubitus ulcer
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Drug eruption
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    2
    0
    0
    Granuloma annulare
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hand dermatitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hidradenitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    2
    0
    0
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    0
    Hyperkeratosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Hyperkeratosis follicularis et parafollicularis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lipodystrophy acquired
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Penile ulceration
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Photodermatosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hirsutism
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pigmentation disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pruritus allergic
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Purpura
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Purpura senile
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Rash macular
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Sensitive skin
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin oedema
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin plaque
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Rosacea
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Renal and urinary disorders
    Crystalluria
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Chronic kidney disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    1
    7
    0
    1
    3
    2
    Chromaturia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Calculus bladder
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    Bladder spasm
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Bladder cyst
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    10 / 1736 (0.58%)
    5 / 3461 (0.14%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    11
    5
    2
    1
    0
    0
    Micturition disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Leukocyturia
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    Hypertonic bladder
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    1
    1
    0
    0
    Hydronephrosis
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Haematuria
         subjects affected / exposed
    10 / 1736 (0.58%)
    22 / 3461 (0.64%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    2 / 74 (2.70%)
    0 / 76 (0.00%)
         occurrences all number
    10
    23
    0
    2
    2
    0
    Dysuria
         subjects affected / exposed
    2 / 1736 (0.12%)
    9 / 3461 (0.26%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    9
    1
    0
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    8 / 1736 (0.46%)
    13 / 3461 (0.38%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    9
    13
    2
    1
    0
    1
    Nocturia
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    3 / 1736 (0.17%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    4
    1
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    2 / 1736 (0.12%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    2
    7
    0
    0
    1
    0
    Renal colic
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Renal cyst
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    3
    1
    1
    0
    1
    Renal failure
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    2
    0
    0
    0
    1
    Renal impairment
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    1
    1
    0
    Stress urinary incontinence
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Ureterolithiasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Urethral meatus stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Urge incontinence
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    1
    2
    0
    0
    Urinary retention
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    4
    0
    1
    0
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    1
    1
    0
    0
    End stage renal disease
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Glycosuria
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Lupus nephritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Microalbuminuria
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Micturition urgency
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Stag horn calculus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Bladder outlet obstruction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Urethral stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Hypogonadism
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Hypothyroidism
         subjects affected / exposed
    5 / 1736 (0.29%)
    9 / 3461 (0.26%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    9
    1
    1
    0
    0
    Goitre
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    2
    1
    0
    0
    Addison's disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Adrenomegaly
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Thyroid mass
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    1
    3
    0
    0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Hypothalamo-pituitary disorder
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pituitary cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Primary hypogonadism
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Thyroid atrophy
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Androgen deficiency
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Ankle deformity
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    51 / 1736 (2.94%)
    122 / 3461 (3.52%)
    5 / 119 (4.20%)
    16 / 234 (6.84%)
    2 / 74 (2.70%)
    3 / 76 (3.95%)
         occurrences all number
    56
    137
    5
    19
    2
    3
    Bursitis
         subjects affected / exposed
    7 / 1736 (0.40%)
    7 / 3461 (0.20%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    7
    8
    2
    1
    1
    0
    Back pain
         subjects affected / exposed
    53 / 1736 (3.05%)
    85 / 3461 (2.46%)
    2 / 119 (1.68%)
    9 / 234 (3.85%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    57
    90
    3
    9
    1
    0
    Arthritis
         subjects affected / exposed
    7 / 1736 (0.40%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    7
    9
    0
    2
    0
    0
    Dupuytren's contracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Coccydynia
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Femoroacetabular impingement
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Fibromyalgia
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    Flank pain
         subjects affected / exposed
    2 / 1736 (0.12%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    6
    0
    0
    0
    0
    Foot deformity
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Joint hyperextension
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    9 / 1736 (0.52%)
    11 / 3461 (0.32%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    10
    11
    1
    1
    0
    0
    Intervertebral disc degeneration
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    1
    0
    0
    0
    Groin pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    2 / 1736 (0.12%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    7
    0
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    4
    1
    1
    0
    1
    Muscle tightness
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    7 / 1736 (0.40%)
    22 / 3461 (0.64%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    7
    22
    1
    2
    1
    1
    Limb discomfort
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    6 / 1736 (0.35%)
    17 / 3461 (0.49%)
    0 / 119 (0.00%)
    4 / 234 (1.71%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    17
    0
    5
    0
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    90 / 1736 (5.18%)
    185 / 3461 (5.35%)
    20 / 119 (16.81%)
    28 / 234 (11.97%)
    2 / 74 (2.70%)
    6 / 76 (7.89%)
         occurrences all number
    102
    207
    25
    34
    2
    7
    Neck pain
         subjects affected / exposed
    12 / 1736 (0.69%)
    12 / 3461 (0.35%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    12
    12
    2
    1
    0
    0
    Osteoarthritis
         subjects affected / exposed
    20 / 1736 (1.15%)
    35 / 3461 (1.01%)
    3 / 119 (2.52%)
    7 / 234 (2.99%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    21
    37
    4
    7
    1
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    4 / 1736 (0.23%)
    11 / 3461 (0.32%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    14
    0
    0
    0
    0
    Osteopenia
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    0
    Osteoporosis
         subjects affected / exposed
    4 / 1736 (0.23%)
    8 / 3461 (0.23%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    8
    0
    1
    0
    0
    Osteoporotic fracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    25 / 1736 (1.44%)
    45 / 3461 (1.30%)
    0 / 119 (0.00%)
    5 / 234 (2.14%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    27
    49
    0
    5
    0
    1
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    5
    0
    2
    0
    0
    Periarthritis
         subjects affected / exposed
    5 / 1736 (0.29%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    2
    1
    0
    0
    0
    Plantar fasciitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    2 / 119 (1.68%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    5
    2
    3
    0
    0
    Polyarthritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pain in jaw
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 1736 (0.06%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    10
    0
    0
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    9 / 1736 (0.52%)
    3 / 3461 (0.09%)
    2 / 119 (1.68%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    9
    3
    2
    1
    0
    0
    Sacroiliitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tendon disorder
         subjects affected / exposed
    4 / 1736 (0.23%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    4
    1
    1
    0
    0
    Spinal pain
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Synovial cyst
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    1
    0
    0
    Temporomandibular joint syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 1736 (0.12%)
    10 / 3461 (0.29%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    11
    0
    2
    0
    0
    Tendon pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Tendonitis
         subjects affected / exposed
    3 / 1736 (0.17%)
    6 / 3461 (0.17%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    3
    7
    1
    1
    0
    1
    Trigger finger
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    2
    1
    0
    0
    0
    Bone pain
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Arthropathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Chondrocalcinosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Chondromalacia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Costochondritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Diastasis recti abdominis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Enostosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Enthesopathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Intervertebral disc displacement
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Exostosis of jaw
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Facet joint syndrome
         subjects affected / exposed
    3 / 1736 (0.17%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    2
    0
    1
    0
    0
    Haemarthrosis
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Intervertebral disc compression
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Exostosis
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Joint ankylosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Joint contracture
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Joint effusion
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Joint noise
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Myositis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Limb mass
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Mobility decreased
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Morphoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Muscle atrophy
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Joint stiffness
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Pathological fracture
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pelvic deformity
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Scapholunate dissociation
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Scoliosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Sjogren's syndrome
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    Patellofemoral pain syndrome
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Spinal stenosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Spondylitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Spondylolisthesis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Synovitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    1
    1
    0
    0
    Tendon calcification
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Osteolysis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Soft tissue mass
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Trismus
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vertebral foraminal stenosis
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    9
    0
    0
    0
    0
    Anal chlamydia infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    10 / 1736 (0.58%)
    32 / 3461 (0.92%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    10
    35
    3
    2
    0
    0
    Asymptomatic bacteriuria
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Bacteraemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    2
    0
    0
    0
    Arthritis bacterial
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    6 / 1736 (0.35%)
    14 / 3461 (0.40%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    14
    1
    2
    0
    0
    Chlamydial infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    0
    Chronic sinusitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    0
    Conjunctivitis
         subjects affected / exposed
    4 / 1736 (0.23%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    4
    4
    0
    1
    1
    0
    Diverticulitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    9 / 3461 (0.26%)
    2 / 119 (1.68%)
    3 / 234 (1.28%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    1
    11
    2
    3
    1
    0
    Cystitis
         subjects affected / exposed
    7 / 1736 (0.40%)
    19 / 3461 (0.55%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    7
    22
    4
    2
    1
    0
    Cystitis escherichia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Dermatophytosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    9 / 1736 (0.52%)
    14 / 3461 (0.40%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    10
    14
    0
    0
    0
    0
    Epididymitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Escherichia infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Eye abscess
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    7 / 1736 (0.40%)
    6 / 3461 (0.17%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    7
    6
    1
    0
    0
    0
    Febrile infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    2
    1
    3
    0
    1
    Fungal infection
         subjects affected / exposed
    3 / 1736 (0.17%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    4
    0
    1
    0
    0
    Eye infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    5
    0
    0
    0
    0
    Furuncle
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    10 / 1736 (0.58%)
    21 / 3461 (0.61%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    10
    21
    1
    1
    0
    0
    Gingival abscess
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gingivitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Herpes simplex
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    7 / 1736 (0.40%)
    16 / 3461 (0.46%)
    2 / 119 (1.68%)
    4 / 234 (1.71%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    7
    16
    2
    4
    1
    0
    Hordeolum
         subjects affected / exposed
    1 / 1736 (0.06%)
    8 / 3461 (0.23%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    9
    1
    1
    0
    0
    Gonorrhoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Infected dermal cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Infected skin ulcer
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    2
    0
    0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    5 / 1736 (0.29%)
    12 / 3461 (0.35%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    3 / 76 (3.95%)
         occurrences all number
    6
    13
    0
    2
    0
    3
    Laryngitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Localised infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    6
    1
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    20 / 1736 (1.15%)
    27 / 3461 (0.78%)
    2 / 119 (1.68%)
    7 / 234 (2.99%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    22
    30
    2
    9
    0
    0
    Nail bed infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    26 / 1736 (1.50%)
    42 / 3461 (1.21%)
    4 / 119 (3.36%)
    12 / 234 (5.13%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    26
    47
    5
    12
    0
    0
    Onychomycosis
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    2
    4
    0
    0
    1
    1
    Paronychia
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Otitis media
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    3
    0
    0
    Periodontitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Pelvic inflammatory disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    4 / 1736 (0.23%)
    8 / 3461 (0.23%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    9
    1
    0
    0
    0
    Oral infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    8 / 1736 (0.46%)
    14 / 3461 (0.40%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    9
    14
    1
    0
    0
    0
    Oral fungal infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    2
    0
    0
    Post procedural pneumonia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Peritonsillar abscess
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Pustule
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    12 / 1736 (0.69%)
    17 / 3461 (0.49%)
    3 / 119 (2.52%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    13
    18
    4
    2
    0
    0
    Pharyngitis bacterial
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    4
    0
    2
    0
    0
    Pilonidal cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    4 / 1736 (0.23%)
    21 / 3461 (0.61%)
    1 / 119 (0.84%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    4
    22
    1
    3
    0
    2
    Sinusitis bacterial
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    0
    Skin bacterial infection
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Skin infection
         subjects affected / exposed
    2 / 1736 (0.12%)
    7 / 3461 (0.20%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    7
    0
    0
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Pyuria
         subjects affected / exposed
    5 / 1736 (0.29%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    5
    10
    0
    0
    0
    1
    Secondary syphilis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    15 / 1736 (0.86%)
    34 / 3461 (0.98%)
    3 / 119 (2.52%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    18
    37
    3
    4
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    2
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    6 / 1736 (0.35%)
    5 / 3461 (0.14%)
    2 / 119 (1.68%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    5
    2
    2
    0
    0
    Sinusitis
         subjects affected / exposed
    19 / 1736 (1.09%)
    34 / 3461 (0.98%)
    3 / 119 (2.52%)
    8 / 234 (3.42%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    23
    39
    3
    9
    1
    2
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    34 / 1736 (1.96%)
    54 / 3461 (1.56%)
    8 / 119 (6.72%)
    8 / 234 (3.42%)
    2 / 74 (2.70%)
    2 / 76 (2.63%)
         occurrences all number
    44
    59
    8
    9
    3
    3
    Tooth infection
         subjects affected / exposed
    6 / 1736 (0.35%)
    15 / 3461 (0.43%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    6
    15
    1
    0
    0
    0
    Tooth abscess
         subjects affected / exposed
    5 / 1736 (0.29%)
    14 / 3461 (0.40%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    5
    14
    1
    2
    0
    1
    Tonsillitis
         subjects affected / exposed
    3 / 1736 (0.17%)
    8 / 3461 (0.23%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    8
    0
    1
    0
    0
    Tinea versicolour
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Tinea pedis
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    0
    Syphilis
         subjects affected / exposed
    5 / 1736 (0.29%)
    6 / 3461 (0.17%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    5
    6
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    59 / 1736 (3.40%)
    122 / 3461 (3.52%)
    10 / 119 (8.40%)
    13 / 234 (5.56%)
    6 / 74 (8.11%)
    6 / 76 (7.89%)
         occurrences all number
    63
    146
    16
    13
    6
    7
    Vaginal cellulitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Wound infection
         subjects affected / exposed
    2 / 1736 (0.12%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    7 / 1736 (0.40%)
    15 / 3461 (0.43%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    7
    15
    0
    2
    0
    0
    Viral rhinitis
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    12 / 1736 (0.69%)
    21 / 3461 (0.61%)
    3 / 119 (2.52%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    12
    23
    3
    0
    0
    0
    Viraemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Vaginal infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Abdominal abscess
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Abscess limb
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    Acarodermatitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Anal candidiasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Balanitis candida
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Arteriovenous graft site infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Atypical pneumonia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Bacterial disease carrier
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Bacterial infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Bacteriuria
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Appendicitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Body tinea
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Bronchitis bacterial
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Candida infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Enterobiasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Coccidioidomycosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Dacryocanaliculitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Dengue haemorrhagic fever
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Device related infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cervicitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Erysipelas
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Fungaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 1736 (0.06%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    5
    0
    2
    0
    0
    Gastrointestinal bacterial overgrowth
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Helicobacter infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Genital herpes
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Genitourinary chlamydia infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gonococcal infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    Groin infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Haemophilus infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Herpes simplex reactivation
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Infected bite
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Infected cyst
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    4
    0
    1
    0
    0
    Infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Lower respiratory tract infection viral
         subjects affected / exposed
    3 / 1736 (0.17%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    4
    0
    0
    0
    0
    Intervertebral discitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Kidney infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Klebsiella infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Lung abscess
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lyme disease
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Lymphangitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Mastitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Mastoiditis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Medical device site abscess
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oropharyngeal gonococcal infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Mucormycosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nasal vestibulitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Norovirus infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Orchitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Molluscum contagiosum
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Osteomyelitis
         subjects affected / exposed
    2 / 1736 (0.12%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    Otitis media acute
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Papilloma viral infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Parotitis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Perichondritis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pertussis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pneumonia bacterial
         subjects affected / exposed
    3 / 1736 (0.17%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pneumonia viral
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Post procedural infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Postoperative wound infection
         subjects affected / exposed
    3 / 1736 (0.17%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    3
    0
    1
    0
    0
    Proctitis gonococcal
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    2 / 119 (1.68%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Respiratory tract chlamydial infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Root canal infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Sepsis
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Sialoadenitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Sinusitis fungal
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Systemic candida
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Tinea cruris
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    Tinea infection
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Trichomoniasis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Spirochaetal infection
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Urethritis gonococcal
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Urinary tract infection staphylococcal
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Viral diarrhoea
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    3
    1
    1
    0
    0
    Asymptomatic COVID-19
         subjects affected / exposed
    17 / 1736 (0.98%)
    28 / 3461 (0.81%)
    7 / 119 (5.88%)
    9 / 234 (3.85%)
    1 / 74 (1.35%)
    3 / 76 (3.95%)
         occurrences all number
    17
    28
    7
    9
    1
    3
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    2 / 119 (1.68%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    4
    1
    2
    3
    0
    0
    Hepatitis C
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    HIV peripheral neuropathy
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    COVID-19
         subjects affected / exposed
    229 / 1736 (13.19%)
    465 / 3461 (13.44%)
    35 / 119 (29.41%)
    64 / 234 (27.35%)
    12 / 74 (16.22%)
    13 / 76 (17.11%)
         occurrences all number
    240
    475
    39
    69
    12
    15
    Suspected COVID-19
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    2
    5
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    30 / 1736 (1.73%)
    67 / 3461 (1.94%)
    9 / 119 (7.56%)
    14 / 234 (5.98%)
    3 / 74 (4.05%)
    1 / 76 (1.32%)
         occurrences all number
    35
    75
    10
    14
    3
    1
    Hyperglycaemia
         subjects affected / exposed
    9 / 1736 (0.52%)
    24 / 3461 (0.69%)
    1 / 119 (0.84%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    9
    24
    1
    2
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 1736 (0.12%)
    6 / 3461 (0.17%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    2 / 76 (2.63%)
         occurrences all number
    2
    6
    0
    3
    0
    2
    Diabetes mellitus
         subjects affected / exposed
    10 / 1736 (0.58%)
    11 / 3461 (0.32%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    1 / 74 (1.35%)
    4 / 76 (5.26%)
         occurrences all number
    11
    11
    1
    1
    1
    4
    Diabetes mellitus inadequate control
         subjects affected / exposed
    3 / 1736 (0.17%)
    4 / 3461 (0.12%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    4
    1
    1
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    3 / 1736 (0.17%)
    18 / 3461 (0.52%)
    5 / 119 (4.20%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    18
    6
    3
    0
    0
    Glucose tolerance impaired
         subjects affected / exposed
    3 / 1736 (0.17%)
    8 / 3461 (0.23%)
    1 / 119 (0.84%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    8
    1
    0
    0
    0
    Gout
         subjects affected / exposed
    2 / 1736 (0.12%)
    13 / 3461 (0.38%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    2 / 74 (2.70%)
    1 / 76 (1.32%)
         occurrences all number
    4
    13
    0
    0
    3
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Folate deficiency
         subjects affected / exposed
    3 / 1736 (0.17%)
    8 / 3461 (0.23%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    3
    8
    0
    1
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    9 / 1736 (0.52%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    9
    9
    0
    0
    1
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    2 / 1736 (0.12%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    2 / 1736 (0.12%)
    4 / 3461 (0.12%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    2
    5
    0
    0
    0
    1
    Iron deficiency
         subjects affected / exposed
    2 / 1736 (0.12%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    3
    0
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    1
    2
    0
    2
    1
    1
    Hypovitaminosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Increased appetite
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    3 / 1736 (0.17%)
    9 / 3461 (0.26%)
    0 / 119 (0.00%)
    4 / 234 (1.71%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    3
    11
    0
    5
    1
    2
    Obesity
         subjects affected / exposed
    0 / 1736 (0.00%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    8 / 1736 (0.46%)
    18 / 3461 (0.52%)
    3 / 119 (2.52%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    2 / 76 (2.63%)
         occurrences all number
    8
    18
    3
    0
    1
    2
    Calciphylaxis
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    3 / 119 (2.52%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    3
    0
    0
    0
    Dyslipidaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    2
    0
    1
    0
    1
    Fluid overload
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    1 / 74 (1.35%)
    1 / 76 (1.32%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    Histamine intolerance
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypernatraemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Malnutrition
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    1 / 119 (0.84%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    3 / 3461 (0.09%)
    0 / 119 (0.00%)
    3 / 234 (1.28%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    4
    0
    3
    0
    1
    Hypophagia
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 1736 (0.06%)
    2 / 3461 (0.06%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    Hypovolaemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lactic acidosis
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 1736 (0.00%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    Metabolic acidosis
         subjects affected / exposed
    1 / 1736 (0.06%)
    0 / 3461 (0.00%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Metabolic syndrome
         subjects affected / exposed
    0 / 1736 (0.00%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    0 / 234 (0.00%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    10 / 1736 (0.58%)
    23 / 3461 (0.66%)
    3 / 119 (2.52%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    1 / 76 (1.32%)
         occurrences all number
    10
    24
    3
    1
    0
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    2 / 1736 (0.12%)
    5 / 3461 (0.14%)
    0 / 119 (0.00%)
    1 / 234 (0.43%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    2
    5
    0
    1
    0
    0
    Vitamin B complex deficiency
         subjects affected / exposed
    1 / 1736 (0.06%)
    1 / 3461 (0.03%)
    0 / 119 (0.00%)
    2 / 234 (0.85%)
    0 / 74 (0.00%)
    0 / 76 (0.00%)
         occurrences all number
    1
    1
    0
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Oct 2020
    Synopsis and Section 4.1 (Overall Design), and Section 7.4 (Study Suspension/Early Termination): Addition of wording that if the study is suspended or the decision is made not to proceed from Stage 1 to Stage 2. Section 5.1 (Inclusion Criteria), Inclusion Criterion 2: Expansion of the criterion to clarify definition of participants who are in an immunocompromised state to include those with solid organ transplant, blood or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immunosuppressive medicines.
    13 Nov 2020
    Changes have been made to the protocol in response to health authority comments, which requested the inclusion of increased safety monitoring with particular emphasis on potential hypersensitivity reactions immediately after IMP administration. As of 14 September 2020 no hypersensitivity reactions have been observed in the Phase I study. Health authority comments also recommended considering testing the null hypothesis of no difference between treatment groups without a specific lower bound to demonstrate statistical superiority over placebo.
    21 Dec 2020
    Due to the ongoing unprecedented situation caused by the COVID-19 pandemic, the criterion excluding AstraZeneca employees has been amended to allow employees and their family members not involved in AZD7442 development to participate in this study, if otherwise eligible. Participants will be permitted to enter the study if they have previously received immunoglobulins, including mAbs that have been approved for an indication other than COVID-19. AZD7442 and other mAbs will not be co-administered. Monoclonal antibodies approved for indications other than COVID-19 that have been administered prior to consideration for this trial will not disqualify a participant from participation in this study. After randomization, they are permitted at any point during the study other than the day of IMP administration. Allowing the use of other mAbs during the study does not appear to pose any safety risk. AZ mAbs bind specifically to the receptor binding domain of the Spike protein of SAR-CoV-2, but not to human targets. Published mAb-mAb interaction studies are rare. One clinical study of co-administration of pertuzumab and trastuzumab + docetaxel via separate infusions, which each bind to different epitopes on the HER2 receptor, illustrated that the PK of one mAb is not affected by the administration of the other (Cortés et al 2013). Therefore, it is not expected that the action of AZD7442 will be affected by the presence of another mAb, including its PK parameters, clearance and elimination. Any potential impact on AZD7442 PK will be examined for any participants that have received a commercial mAb.
    12 Feb 2021
    The study had been initially sized to allow for a more detailed assessment of efficacy, including greater precision in subpopulations, and therefore had >95% power to demonstrate that the lower bound of the 2-sided 95% CI for efficacy is greater than 0 (assuming an observed annualized attack rate of 3% in the placebo group and true efficacy of 80%). Efficacious vaccines against SARS-CoV-2 are being deployed on a mass scale in the participating countries and a higher proportion of participants in the study are electing to become unblinded to consider vaccination for COVID-19 than was originally expected. To reduce the potential impact of unblinding on the study’s ability to robustly quantify efficacy, the primary analysis will be conducted at an earlier time point and the strategy for handling intercurrent events for the primary efficacy endpoint will be changed from a treatment policy strategy to a while on treatment strategy, which was previously a sensitivity analyses. The amended study design will have ~90% power to demonstrate that the lower bound of the 2-sided 95% CI for efficacy is greater than 0 with the same assumptions. The study is being conducted using AZD7442 material derived from a non-clonal pool of cells from a pooled batch (separately manufactured pools for AZD8895 and AZD1061). Clonal material from a single production cell line that forms a Master Cell bank will be used as the source of the commercial supply. The addition of a subset of participants in study, to be treated with the clonal material, will provide clinical data on the clonal material in the prophylaxis population. To incorporate health authority feedback, a subset of additional 150 participants will be included to receive clonal IMP or placebo in a 2:1 ratio. The sample size has been increased from 5000 to 5150 participants. The clonal material subset will be enrolled in the US
    18 Mar 2021
    Highly efficacious vaccines against SARS-CoV-2 are being deployed on a mass scale in the participating countries and a higher proportion of participants in the study are electing to become unblinded to consider vaccination for COVID-19 than was originally expected. In order to further reduce the potential impact of unblinding on the study’s ability to robustly quantify efficacy, the primary analysis will be conducted 30 days after the 24th primary endpoint event has occurred. This period allows sufficient time for absorption and systemic exposure of AZD7442 administered IM and any other events occurring during this time interval will also be evaluated. Furthermore, to remove recruitment restrictions the stratification caps have been removed from Cohorts 1 and 2. To provide data on AZD7442 for 5 half-lives, the study has been extended to 15 months allowing a safety assessment via a phone call and an optional serum sample for PK, ADA, and nAb to be added at Day 457. Study endpoints have been adjusted accordingly.
    07 Apr 2021
    Highly efficacious vaccines against SARS-CoV-2 are being deployed on a mass scale in the participating countries and a higher proportion of participants in the study are electing to become unblinded to consider vaccination for COVID-19 than was originally expected. The process of vaccination has accelerated further in the past 2 to 3 weeks. Consequently, the probability to observe primary endpoint events will diminish with increasing vaccination of the enrolled population. Modelling results suggest that the unblinding rate is increasing over time and that by the time 30% unblinding is reached, the annualized attack rate will have begun to decelerate and will further decline in proportion to the unblinding. This puts the delivery of the study at significant risk. In order to reduce the potential impact of unblinding on the study’s ability to robustly quantify placebo-controlled efficacy, the primary analysis has been adjusted to be conducted after approximately 24 primary endpoint events have been confirmed or 30% of study participants have become unblinded, whichever occurs first. Taking the earlier of these 2 scenarios will avoid an unnecessary delay to reporting trial results irrespective of additional unblinding acceleration. Additionally, the 30-day observation period has been removed as the current pace of unblinding makes this addition untenable. If the unblinding rate does not accelerate beyond the predicted, then the study is likely to observe the 24 primary endpoint events (congruent with the previous version of the protocol).
    29 Jun 2021
    The strategy for handling intercurrent events for the primary efficacy endpoint is to censor participants who become unblinded to treatment assignment to consider vaccination against COVID-19 at the date of unblinding, regardless of whether they subsequently receive a COVID-19 vaccine/preventive product. While the impact of unblinding on the interpretation of the primary endpoint is unknown, receipt of vaccine is expected to affect the interpretation since efficacy of COVID-19 vaccines has been demonstrated. Therefore, an additional estimand strategy, in which the intercurrent event is receipt of a COVID-19 vaccine, has been included as a key supportive analysis of the primary endpoint. The level of unblinding at the primary analysis will be approximately 30% and is likely to increase as the study continues. Since participants who become unblinded to treatment assignment are censored at the date of unblinding for the key secondary objective to estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 through Day 366, it is unlikely to yield different results from that of the primary analysis. Therefore, this secondary objective will be changed to an exploratory objective and the endpoint of incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring after dosing with IMP through Day 366 removed from the multiple testing hierarchy. Instead, the important secondary objective to estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection and endpoint of incidence of participants who have a post-treatment response for SARS-CoV-2 nucleocapsid antibodies will be included in the multiple testing hierarchy
    26 Jul 2021
    In response to health authority feedback, the following changes have been made: The primary analysis of the primary endpoint will include all participants who were hospitalized due to COVID-19, regardless of severity. Previously, only participants who were hospitalized due to COVID-19 that met the protocol-defined criteria for severe were included. The key supportive analysis of the primary endpoint, in which participants who receive a COVID-19 vaccine or preventive product are censored 14 days following receipt (referred to as “vaccine-efficacy censor” estimand), has been removed. A key supportive analysis of the primary endpoint, in which the endpoint is defined as the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness or death from any cause post dose of IMP and prior to Day 183, has been added and included in the hierarchical testing strategy. In addition, an independent Morbidity Adjudication Committee will be constituted to provide an independent, external, systematic, and unbiased assessment of blinded data to evaluate whether the causes of death for participants are considered COVID-19 associated. Only adjudicated deaths will be included in efficacy endpoints. All fatal events will be further assessed as part of safety evaluation. Further details of this adjudication will be provided in a separate Morbidity Adjudication Committee Charter. A clarification that all participants who become unblinded to treatment (regardless of the reason) will be considered as intercurrent events rather than only those who became unblinded to consider vaccination for COVID-19.
    01 Dec 2021
    An addendum has been added to include a sub-study to the Phase III PROVENT study: ‘A Phase III Multi-center, Open-label Sub-study in Adults to Assess the Safety, PK, and Immunogenicity of Repeat Doses of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061) (The PROVENT Repeat Dose Sub-study)’(D8850C002A01). The sub-study will assess the safety, PK, and immunogenicity of repeat doses of AZD7442 in participants currently enrolled in the PROVENT study who may benefit from a repeat dose of AZD7442. This study will investigate whether additional doses of AZD7442 have an appropriate safety profile in this vulnerable population. Pharmacokinetic data will also be generated to evaluate whether repeat dosing can maintain serum levels associated with protection against COVID-19. Participants at a sub-set of active PROVENT parent study sites in participating countries will be invited to enroll in this sub-study (N=500). The conduct of the parent study will not change for those participants who are not included in the sub-study.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Mar 2023
    On 30 March 2023, the FDA requested AstraZeneca to stop dosing adult participants in the US until the informed consent form had been updated to reflect the new benefit-risk assessment as, given that AZD7442 (EVUSHELD™) was not active against > 99% of the circulating SARS-CoV-2 variants in the US at that time, the benefit-risk assessment may not be favorable. AstraZeneca made the decision to stop dosing globally in all ongoing EVUSHELD studies including the PROVENT Sub-study and updated the informed consent form detailing the FDA guidance and decision to stop dosing globally. All actively enrolled participants were reconsented and remained in the study to complete visits/assessments (except those related to monitoring of IMP administration) for safety for at least 6 months after the last IMP administration.
    -

    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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