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    Clinical Trial Results:
    A Phase 3, Randomized, Placebo-Controlled, Observer Blind, Multi-Country Study To Demonstrate the Efficacy Of A Single Dose And Annual Revaccination Of GSK’s RSVPreF3 OA Investigational Vaccine In Adults Aged 60 Years And Above.

    Summary
    EudraCT number
    2020-000753-28
    Trial protocol
    BE   FI   DE   IT   SE   HU  
    Global end of trial date
    31 May 2024

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Jun 2025
    First version publication date
    15 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    212494
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue De L'institut 89, Rixensart, Belgium, 1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.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
    16 Jul 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed lower respiratory tract disease (LRTD) in adults ≥ 60 YOA.
    Protection of trial subjects
    Study participants were observed closely for at least 30 minutes after the administration of the study interventions. Appropriate medical treatment was readily available during the observation period in case of anaphylaxis or syncope.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 282
    Country: Number of subjects enrolled
    Belgium: 996
    Country: Number of subjects enrolled
    Canada: 1923
    Country: Number of subjects enrolled
    Estonia: 430
    Country: Number of subjects enrolled
    Finland: 983
    Country: Number of subjects enrolled
    Germany: 2808
    Country: Number of subjects enrolled
    Italy: 245
    Country: Number of subjects enrolled
    Japan: 1043
    Country: Number of subjects enrolled
    Korea, Republic of: 720
    Country: Number of subjects enrolled
    Mexico: 587
    Country: Number of subjects enrolled
    New Zealand: 247
    Country: Number of subjects enrolled
    Poland: 2355
    Country: Number of subjects enrolled
    Russian Federation: 615
    Country: Number of subjects enrolled
    South Africa: 1490
    Country: Number of subjects enrolled
    Spain: 1093
    Country: Number of subjects enrolled
    United Kingdom: 2929
    Country: Number of subjects enrolled
    United States: 7929
    Worldwide total number of subjects
    26675
    EEA total number of subjects
    8910
    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)
    6843
    From 65 to 84 years
    19251
    85 years and over
    581

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Out of 26675 participants enrolled in the study, 24972 received study intervention and were included in the Exposed set and started the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    RSVPreF3 Group
    Arm description
    Participants received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants in this group were re-randomized into 2 as: a group that received placebo every subsequent year, and a group that received an additional dose of RSVPreF3 OA vaccine every subsequent year of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    RSVPreF3 OA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at Day 1 in the RSVPreF3 group, and before Season 2 to the participants of the RSVPreF3 group that are re-randomized to the RSV_annual and RSV_1_dose groups.

    Arm title
    Placebo Group
    Arm description
    Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study.
    Arm type
    Placebo

    Investigational medicinal product name
    Saline solution (Placebo)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Saline solution administered intramuscularly into the deltoid of the non-dominant arm at Day 1, followed by additional annual administration of saline solution.

    Number of subjects in period 1 [1]
    RSVPreF3 Group Placebo Group
    Started
    12469
    12503
    RSV_1_dose
    4721 [2]
    0 [3]
    RSV_annual
    4644 [4]
    0 [5]
    Completed
    9365
    9361
    Not completed
    3104
    3142
         Migrated/moved from the study area
    201
    184
         Adverse event, non-fatal
    442
    441
         Not specified
    298
    326
         Lost to follow-up
    448
    465
         Consent withdrawal, not due to a (S)AE
    1715
    1726
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The wordwide number of participants is presented on the Enrolled set, which included participants eligible to enter the study. The Baseline periodis presented on the Exposed set, which included all participants that received at least one study intervention.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants in RSVPreF3 group were redirected to receive placebo or RSVPreF3 dose every subsequent year, before start of Season 2. Hence participants were split based on subsequent intervention.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants in Placebo group continued the study in the same group, and did not receive any other type of intervention beside placebo solution. Hence no participant in this group was redirected to RSV_annual or RSV_1_dose groups.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants in RSVPreF3 group were redirected to receive placebo or RSVPreF3 dose every subsequent year, before start of Season 2. Hence participants were split based on subsequent intervention.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants in Placebo group continued the study in the same group, and did not receive any other type of intervention beside placebo solution. Hence no participant in this group was redirected to RSV_annual or RSV_1_dose groups.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RSVPreF3 Group
    Reporting group description
    Participants received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants in this group were re-randomized into 2 as: a group that received placebo every subsequent year, and a group that received an additional dose of RSVPreF3 OA vaccine every subsequent year of the study.

    Reporting group title
    Placebo Group
    Reporting group description
    Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study.

    Reporting group values
    RSVPreF3 Group Placebo Group Total
    Number of subjects
    12469 12503 24972
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    6962 6982 13944
        From 65-84 years
    4489 4493 8982
        85 years and over
    1018 1028 2046
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.6 ( 6.5 ) 69.6 ( 6.4 ) -
    Sex: Female, Male
    Units: Participants
        MALE
    5980 6074 12054
        FEMALE
    6489 6429 12918
    Race/Ethnicity, Customized
    Races where 0<n<11 (i.e., Native Hawaiian or Other Pacific Islander and American Indian or Alaska Native) are combined into one category ("All Other Races") to maintain participant confidentiality and privacy.
    Units: Subjects
        Asian
    953 956 1909
        Black or African American
    1064 1101 2165
        White
    9889 9936 19825
        All Other Races
    55 41 96
        Other
    508 469 977
    Age, Continuous
    Units: YEARS
        arithmetic mean (standard deviation)
    69.5 ( 6.5 ) 69.6 ( 6.4 ) -

    End points

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    End points reporting groups
    Reporting group title
    RSVPreF3 Group
    Reporting group description
    Participants received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants in this group were re-randomized into 2 as: a group that received placebo every subsequent year, and a group that received an additional dose of RSVPreF3 OA vaccine every subsequent year of the study.

    Reporting group title
    Placebo Group
    Reporting group description
    Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_1_dose Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received a dose of placebo every subsequent year after the vaccination at Day 1 of the study.

    Subject analysis set title
    RSV_annual Group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year after the vaccination at Day 1 of the study.

    Primary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated lower respiratory tract disease (LRTD) during the first season following a single dose of the RSVPreF3 OA vaccine

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated lower respiratory tract disease (LRTD) during the first season following a single dose of the RSVPreF3 OA vaccine
    End point description
    First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR. Analysis was performed on the modified Exposed Set (mES), which included all participants who received at least the first dose of the study intervention and who do not report an RSV-confirmed Acute Respiratory Illness (ARI) prior to 2 weeks (<Day 15) after each vaccination (mES-RSV set). Only participants with data available at specified timepoints were included in analysis.
    End point type
    Primary
    End point timeframe
    From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [assessed approximately 6.7 months per participant]
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12466
    12494
    Units: Participants
    7
    40
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To demonstrate the vaccine efficacy (VE) efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD during the first season in adults ≥ 60 YOA
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24960
    Analysis specification
    Pre-specified
    Analysis type
    [1]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    82.58
    Confidence interval
         level
    96.95%
         sides
    2-sided
         lower limit
    57.89
         upper limit
    94.08
    Notes
    [1] - VE is demonstrated if the lower limit (LL) of the 2-sided confidence interval (CI) for vaccine efficacy (VE) is above 20%.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD over several seasons following annual revaccination doses of the RSVPreF3 OA vaccine

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD over several seasons following annual revaccination doses of the RSVPreF3 OA vaccine
    End point description
    Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine was assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the NH (assessed approximately over 2 and 3 years in NH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12469
    12498
    Units: Participants
        Season 2 (NH)
    30
    139
        Season 3 (NH)
    38
    192
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24967
    Analysis specification
    Pre-specified
    Analysis type
    [2]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    67.12
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    48.09
         upper limit
    80
    Notes
    [2] - VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24967
    Analysis specification
    Pre-specified
    Analysis type
    [3]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    67.76
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    51.82
         upper limit
    79.11
    Notes
    [3] - VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD over several seasons following a single dose of the RSVPreF3 OA vaccine

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD over several seasons following a single dose of the RSVPreF3 OA vaccine
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere [NH] (assessed approximately over 2 and 3 years in NH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12469
    12498
    Units: Participants
        Season 2 (NH)
    30
    139
        Season 3 (NH)
    48
    215
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24967
    Analysis specification
    Pre-specified
    Analysis type
    [4]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    67.18
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    48.19
         upper limit
    80.04
    Notes
    [4] - VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24967
    Analysis specification
    Pre-specified
    Analysis type
    [5]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    62.91
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    46.74
         upper limit
    74.79
    Notes
    [5] - VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV subtype A and subtype B LRTD over 3 seasons following a single dose of the RSVPreF3 OA vaccine

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV subtype A and subtype B LRTD over 3 seasons following a single dose of the RSVPreF3 OA vaccine
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH)
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12468
    12498
    Units: Participants
        RT-PCR-confirmed RSV-A LRTD
    14
    80
        RT-PCR-confirmed RSV-B LRTD
    34
    135
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [6]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    58.57
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    35.9
         upper limit
    74.11
    Notes
    [6] - VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [7]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    69.83
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    42.18
         upper limit
    85.72
    Notes
    [7] - VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.

    Secondary: Number of participants with first episode of RT-PCR confirmed LRTD caused by human metapneumovirus (hMPV) up to the end of season 1 following a single dose of the RSVPreF3 OA vaccine

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    End point title
    Number of participants with first episode of RT-PCR confirmed LRTD caused by human metapneumovirus (hMPV) up to the end of season 1 following a single dose of the RSVPreF3 OA vaccine
    End point description
    Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post-vaccination up to end of season 1 in the SH [assessed approximately 6 months per participant]
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12469
    12503
    Units: Participants
    53
    65
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hMPV-confirmed LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine up to the end of Season 1.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    [8]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    18.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.1
         upper limit
    44.33
    Notes
    [8] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD, by age categories following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD, by age categories following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, in the following age categories: greater than or equal to (≥) 65 years of age (YOA), ≥70 YOA and ≥80 YOA. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    9261
    9328
    Units: Participants
        LRTD (Single dose), >=65 YOA
    38
    156
        LRTD (Single dose), >=70 YOA
    20
    98
        LRTD (Single dose), >=80 YOA
    5
    13
        RSV LRTD (Annual revaccination), >=65 YOA
    28
    137
        LRTD (Annual revaccination), >=70 YOA
    19
    87
        LRTD (Annual revaccination), >=80 YOA
    5
    12
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by >=65YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    18589
    Analysis specification
    Pre-specified
    Analysis type
    [9]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    58.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40.73
         upper limit
    71.96
    Notes
    [9] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by >=70YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    18589
    Analysis specification
    Pre-specified
    Analysis type
    [10]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    65.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    44.32
         upper limit
    80.16
    Notes
    [10] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by >=80YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    18589
    Analysis specification
    Pre-specified
    Analysis type
    [11]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    32.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -108.42
         upper limit
    81.73
    Notes
    [11] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by >=65YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    18589
    Analysis specification
    Pre-specified
    Analysis type
    [12]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    66.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.33
         upper limit
    78.64
    Notes
    [12] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by >=70YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    18589
    Analysis specification
    Pre-specified
    Analysis type
    [13]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    64.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40.49
         upper limit
    79.55
    Notes
    [13] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by >=80YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    18589
    Analysis specification
    Pre-specified
    Analysis type
    [14]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    36.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -93.99
         upper limit
    82.47
    Notes
    [14] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by RSV season following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by RSV season following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by RSV season as follows: VE after each season includes the first occurrence of episodes reported from Day 15 post vaccination at first season, and for the next seasons, excluding analysis of participants who already reported a case in the previous season. The RSV season may be extended based on epidemiology data. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. Analysis is presented based on the groups at each season (RSVPreF3 group for Season 1, RSV_1_dose and RSV_annual groups for Seasons 2 and 3, Placebo group for Season 1, 2 and 3).
    End point type
    Secondary
    End point timeframe
    From Day 15 post first dose or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season [Seasons 1 and 2 in SH, Seasons 1, 2 and 3 in NH])
    End point values
    RSVPreF3 Group Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    12468
    12498
    4988
    4968
    Units: Participants
        Season 1
    7
    36
    99999
    99999
        Season 2 (Single dose)
    99999
    98
    19
    99999
        Season 2 (Annual revaccination)
    99999
    98
    99999
    22
        Season 3 (Single dose)
    99999
    60
    16
    99999
        Season 3 (Annual revaccination)
    99999
    37
    99999
    6
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    Placebo Group v RSV_1_dose Group
    Number of subjects included in analysis
    17486
    Analysis specification
    Pre-specified
    Analysis type
    [15]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    61.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    36.44
         upper limit
    77.7
    Notes
    [15] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [16]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    80.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.9
         upper limit
    92.73
    Notes
    [16] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    Placebo Group v RSV_annual Group
    Number of subjects included in analysis
    17466
    Analysis specification
    Pre-specified
    Analysis type
    [17]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    54.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    27.85
         upper limit
    72.98
    Notes
    [17] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    Placebo Group v RSV_1_dose Group
    Number of subjects included in analysis
    17486
    Analysis specification
    Pre-specified
    Analysis type
    [18]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    47.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.06
         upper limit
    71.59
    Notes
    [18] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    Placebo Group v RSV_annual Group
    Number of subjects included in analysis
    17466
    Analysis specification
    Pre-specified
    Analysis type
    [19]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    67.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22.35
         upper limit
    88.79
    Notes
    [19] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by year following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by year following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by years after vaccination as follows: VE at each year includes the first occurrence of episodes reported from Day 14 post vaccination at first year, and for the next years, excluding analysis of participants who already reported a case in the previous year. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. Analysis is presented based on the groups at each season (RSVPreF3 group for Year 1, RSV_1_dose and RSV_annual groups for Years 2 and 3, Placebo group for Years 1, 2 and 3).
    End point type
    Secondary
    End point timeframe
    From Day 15 post first dose and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination [at Year 1, Year 2 and Year 3])
    End point values
    RSVPreF3 Group Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    12468
    12498
    4988
    4968
    Units: Participants
        RSV LRTD, Year 1
    10
    47
    99999
    99999
        RSV LRTD, Year 2 (Single dose)
    99999
    106
    22
    99999
        RSV LRTD, Year 2 (Annual revaccination)
    99999
    106
    99999
    22
        RSV LRTD, Year 3 (Single dose)
    99999
    61
    16
    99999
        RSV LRTD, Year 3 (Annual revaccination)
    99999
    38
    99999
    6
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [20]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    78.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.62
         upper limit
    90.48
    Notes
    [20] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    Placebo Group v RSV_1_dose Group
    Number of subjects included in analysis
    17486
    Analysis specification
    Pre-specified
    Analysis type
    [21]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    58.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    34
         upper limit
    75.1
    Notes
    [21] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    Placebo Group v RSV_annual Group
    Number of subjects included in analysis
    17466
    Analysis specification
    Pre-specified
    Analysis type
    [22]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    68.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    24.64
         upper limit
    89.08
    Notes
    [22] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    Placebo Group v RSV_annual Group
    Number of subjects included in analysis
    17466
    Analysis specification
    Pre-specified
    Analysis type
    [23]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    58.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    33.59
         upper limit
    74.94
    Notes
    [23] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    Placebo Group v RSV_1_dose Group
    Number of subjects included in analysis
    17486
    Analysis specification
    Pre-specified
    Analysis type
    [24]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    47.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    8.51
         upper limit
    71.97
    Notes
    [24] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and /or B associated LRTD, following a single dose of the RSVPreF3 OA vaccine

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and /or B associated LRTD, following a single dose of the RSVPreF3 OA vaccine
    End point description
    Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the NH and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12468
    12498
    Units: Participants
        Season 1
    10
    47
        Season 2 (Single dose)
    32
    154
        Season 2 (Annual revaccination)
    32
    154
        Season 3 (NH) (Single dose)
    48
    215
        Season 3 (NH) (Annual revaccination)
    38
    192
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the evolution of efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 1.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [25]
    Method
    Regression, Cox
    Parameter type
    VE
    Point estimate
    78.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.95
         upper limit
    89.26
    Notes
    [25] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [26]
    Method
    Regression, Cox
    Parameter type
    VE
    Point estimate
    67.63
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.47
         upper limit
    77.95
    Notes
    [26] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses. 
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [27]
    Method
    Regression, Cox
    Parameter type
    VE
    Point estimate
    67.66
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.71
         upper limit
    78.34
    Notes
    [27] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [28]
    Method
    Regression, Cox
    Parameter type
    VE
    Point estimate
    67.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.27
         upper limit
    77.86
    Notes
    [28] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [29]
    Method
    Regression, Cox
    Parameter type
    VE
    Point estimate
    62.87
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.76
         upper limit
    74.11
    Notes
    [29] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses. 

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline comorbidities using Charlson Comorbidity Index following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline comorbidities using Charlson Comorbidity Index following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities using Charlson Comorbidity Index. Low/medium Risk = Participants with co-morbidity score at baseline less than or equal to 3 (Charlson Index); High Risk = Participants with co-morbidity score at baseline greater than 3 (Charlson Index). Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    8126
    8268
    Units: Participants
        Single dose, Low/Medium risk
    24
    119
        Single dose, High risk
    24
    96
        Annual revaccination, Low/Medium risk
    18
    108
        Annual revaccination, High risk
    20
    84
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    16394
    Analysis specification
    Pre-specified
    Analysis type
    [30]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    66.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    47.54
         upper limit
    79.4
    Notes
    [30] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    16394
    Analysis specification
    Pre-specified
    Analysis type
    [31]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    61.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.17
         upper limit
    78.01
    Notes
    [31] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    16394
    Analysis specification
    Pre-specified
    Analysis type
    [32]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    72.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.34
         upper limit
    84.37
    Notes
    [32] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    16394
    Analysis specification
    Pre-specified
    Analysis type
    [33]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    58.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    34.81
         upper limit
    74.98
    Notes
    [33] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline comorbidities according to comorbidities of interest following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline comorbidities according to comorbidities of interest following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities of interest divided into 2: cardiorespiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory or pulmonary disease, and endocrinometabolic conditions such as diabetes mellitus type 1 or 2, chronic heart failure and advanced liver or renal disease. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    7454
    7547
    Units: Participants
        Single dose, No pre-existing CoI
    23
    99
        Single dose, At least 1 pre-existing CoI
    25
    116
        Single dose, At least 1 pre-existing CR
    17
    85
        Single dose, At least 1 pre-existing EM
    12
    55
        Ann. revaccination, No pre-existing CoI
    20
    91
        Ann. revaccination, At least 1 pre-existing CoI
    18
    101
        Ann. revaccination, At least 1 pre-existing CR
    11
    73
        Ann. revaccination, At least 1 pre-existing EM
    9
    49
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    15001
    Analysis specification
    Pre-specified
    Analysis type
    [34]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    61.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    38.62
         upper limit
    76.74
    Notes
    [34] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    15001
    Analysis specification
    Pre-specified
    Analysis type
    [35]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    64.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    45.1
         upper limit
    78.14
    Notes
    [35] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    15001
    Analysis specification
    Pre-specified
    Analysis type
    [36]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    68.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    45.71
         upper limit
    82.33
    Notes
    [36] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    15001
    Analysis specification
    Pre-specified
    Analysis type
    [37]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    63.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    31.35
         upper limit
    82.48
    Notes
    [37] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    15001
    Analysis specification
    Pre-specified
    Analysis type
    [38]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    64.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    41.08
         upper limit
    79.17
    Notes
    [38] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    15001
    Analysis specification
    Pre-specified
    Analysis type
    [39]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    71.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.92
         upper limit
    83.65
    Notes
    [39] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition,following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    15001
    Analysis specification
    Pre-specified
    Analysis type
    [40]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    75.94
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.11
         upper limit
    88.54
    Notes
    [40] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    15001
    Analysis specification
    Pre-specified
    Analysis type
    [41]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    69.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.51
         upper limit
    87.05
    Notes
    [41] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline frailty status following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline frailty status following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and /or B associated LRTD episode according to the case definition, by baseline frailty status of frail, pre-frail and fit. Frail = Participants with a walking speed of less than (<) 0.4 meters per second (m/s) or who were not able to perform the test; Pre-Frail = Participants with a walking speed between 0.4-0.99 m/s; Fit = Participants with a walking speed of ≥1 m/s. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    7464
    7523
    Units: Participants
        Single dose, Frail
    2
    1
        Single dose, Pre-Frail
    12
    67
        Single dose, Fit
    34
    145
        Annual revaccination, Frail
    1
    1
        Annual revaccination, Pre-Frail
    10
    63
        Annual revaccination, Fit
    27
    126
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    14987
    Analysis specification
    Pre-specified
    Analysis type
    [42]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    -153.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16322.9
         upper limit
    88
    Notes
    [42] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    14987
    Analysis specification
    Pre-specified
    Analysis type
    [43]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    64.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.1
         upper limit
    77.75
    Notes
    [43] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    14987
    Analysis specification
    Pre-specified
    Analysis type
    [44]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    13.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6751.38
         upper limit
    98.91
    Notes
    [44] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    14987
    Analysis specification
    Pre-specified
    Analysis type
    [45]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    74.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.33
         upper limit
    88.31
    Notes
    [45] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    14987
    Analysis specification
    Pre-specified
    Analysis type
    [46]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    70.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.89
         upper limit
    85.33
    Notes
    [46] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    14987
    Analysis specification
    Pre-specified
    Analysis type
    [47]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    61.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.89
         upper limit
    74.08
    Notes
    [47] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated severe LRTD following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated severe LRTD following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated severe LRTD episode. Case definition for RSV-confirmed severe LRTD: An RT-PCR confirmed case of RSV-associated severe LRTD is characterized by presence of lower respiratory signs or an LRTD episode assessed as severe by the investigator (Severe LRTD case definition 1) or presence of an LRTD with need for oxygen supplementation or need for positive airway pressure therapy or need for other types of mechanical ventilation (Severe LRTD case definition 2) and with at least one RSV positive swab detected by RT-PCR. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12468
    12498
    Units: Participants
        Single dose, Any
    15
    75
        Single dose, Definition 1
    15
    75
        Single dose, Definition 2
    2
    7
        Annual revaccination, Any
    9
    67
        Annual revaccination, Definition 1
    9
    67
        Annual revaccination, Definition 2
    0
    6
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [48]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    67.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.43
         upper limit
    82.68
    Notes
    [48] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [49]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    67.38
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.43
         upper limit
    82.68
    Notes
    [49] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [50]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.27
         upper limit
    100
    Notes
    [50] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [51]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    78.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.05
         upper limit
    90.75
    Notes
    [51] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [52]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    78.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.05
         upper limit
    90.75
    Notes
    [52] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to the case definition 2, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [53]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    59.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -119.6
         upper limit
    95.93
    Notes
    [53] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV A and/or B associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV confirmed A and/or B associated ARI episode. A case of RT-PCR confirmed RSV-associated ARI is characterized by the presence of respiratory symptoms/signs for at least 24 hours OR respiratory symptom/sign + systemic symptom/sign for at least 24 hours with at least one RSV-positive swab detected by RT-PCR. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12468
    12498
    Units: Participants
        RT-PCR-confirmed RSV ARI (Single dose)
    131
    428
        RT-PCR-confirmed RSV ARI (Annual revaccination)
    103
    385
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [54]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    58.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48.1
         upper limit
    66.96
    Notes
    [54] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [55]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    51.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40.31
         upper limit
    60.21
    Notes
    [55] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with first episode of any ARI or any LRTD following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Number of participants with first episode of any ARI or any LRTD following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against any ARI and any LRTD. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12469
    12503
    Units: Participants
        Any ARI (Single dose)
    4858
    6096
        Any ARI (Annual revaccination)
    4731
    5914
        Any LRTD (Single dose)
    12450
    3352
        Any LRTD (Annual revaccination)
    2308
    3210
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    other [56]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    2.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.47
         upper limit
    5.99
    Notes
    [56] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    other [57]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    6.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.81
         upper limit
    11.9
    Notes
    [57] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    other [58]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    3.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.55
         upper limit
    8.63
    Notes
    [58] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    other [59]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    3.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    6.98
    Notes
    [59] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest score for the participants with RT-PCR-confirmed RSV A and/or B-associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Maximum Influenza Patient-Reported Outcome (Flu-PRO) Chest score for the participants with RT-PCR-confirmed RSV A and/or B-associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    For this outcome measure, the Health Related -Quality of life (HR-QOL) score is measured by Flu-PRO questionnaire version 2.0. The Flu-PRO is a 32 items daily diary, which assesses influenza signs across 6 body systems- nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The objective of this outcome measure was to present data only for chest/respiratory system after a single dose and after annual revaccination. The FLU-PRO score was computed as the mean score across questionaire items for chest/respiratory body system, with the scores ranging from 0 (symptom free) to 4 (very severe symptoms). Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH])
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    121
    377
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Chest / Respiratory (Single dose)
    1.60 ( 0.89 )
    1.97 ( 0.88 )
        Chest / Respiratory (Annual revaccination)
    1.50 ( 0.87 )
    1.96 ( 0.89 )
    No statistical analyses for this end point

    Secondary: Least Square Mean Flu-PRO total score for the participants with RT-PCR-confirmed RSV A and/or B-associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Least Square Mean Flu-PRO total score for the participants with RT-PCR-confirmed RSV A and/or B-associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    The Flu-PRO questionnaire version 2.0 is a 32 items daily diary, which assesses influenza signs across 6 body systems- nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The FLU-PRO total score was computed as the mean score across all 32 items of the questionaire for all 6 body systems, with the total scores ranging from 0 (symptom free) to 4 (very severe symptoms). Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    During the first 7 days from the onset of ARI symptoms (assessed from Day 15 post first vaccination dose until end of study [approximately 3 years in NH and 2.5-3 years in SH])
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    131
    428
    Units: Scores on a scale
    least squares mean (standard error)
        Day 1 to Day 7 (Single dose)
    0.85 ( 0.07 )
    0.92 ( 0.06 )
        Day 1 to Day 7 (Annual revaccination)
    0.81 ( 0.07 )
    0.90 ( 0.06 )
    No statistical analyses for this end point

    Secondary: EuroQol 5-dimension health questionnaire (EQ-5D) utility score for participants with RT-PCR-confirmed RSV A and/or B-associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    EuroQol 5-dimension health questionnaire (EQ-5D) utility score for participants with RT-PCR-confirmed RSV A and/or B-associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    The EQ-5D is a general health utility questionnaire with health states, defined through 5 dimensions- mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. A participant who responds 1 (no problem/no symptom) to all 5 items has a profile “11111” and similarly a participant who responds 3 (the highest level of difficulty or symptom) to all items has a profile “33333”. The health states indicated in these 5 dimensions are converted and presented as a single mean index value as recommended by EuroQol group, where values range from 0 (worst) to 1 (full health). Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    At the ARI visit (assessed from Day 15 post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    106
    362
    Units: Scores on a scale
    least squares mean (standard error)
        At ARI visit (Single dose)
    0.8164 ( 0.0258 )
    0.7886 ( 0.0197 )
        At ARI visit (Annual revaccination)
    0.8377 ( 0.0259 )
    0.7966 ( 0.0197 )
    No statistical analyses for this end point

    Secondary: Least square mean of Short Form-12 (SF-12) health survey for participants with RT-PCR confirmed RSV A and/or B-associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses

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    End point title
    Least square mean of Short Form-12 (SF-12) health survey for participants with RT-PCR confirmed RSV A and/or B-associated ARI following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses
    End point description
    SF-12 is a health survey with 12 questions, covering 8 domains- physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Summary scores are computed from these domains for the physical and mental component. The total score of the SF-12 questionnaire is evaluated on a scale from 0 to 100, with a higher score indicating a better perceived health-related quality of life. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    105
    361
    Units: Scores on a scale
    least squares mean (standard error)
        At ARI visit (Single dose)
    59.43 ( 4.07 )
    57.51 ( 3.15 )
        At ARI visit (Annual revaccination)
    63.65 ( 4.15 )
    59.02 ( 3.18 )
    No statistical analyses for this end point

    Secondary: Duration in days of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes

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    End point title
    Duration in days of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes
    End point description
    The duration in days of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes are described. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first dose to end of Season 1, from 15 days post-second dose administration to end of Season 2, and from start to end of Season 3 [all seasons summing approximately 3 years in NH and 2.5-3 years in SH]
    End point values
    RSVPreF3 Group Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    40
    208
    61
    45
    Units: Days
    median (inter-quartile range (Q1-Q3))
        RT-PCR-confirmed RSV ARI, Season 1
    12.0 (8.0 to 19.0)
    15.0 (11.0 to 22.0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        RT-PCR-confirmed RSV LRTD, Season 1
    15.5 (8.0 to 19.0)
    20.0 (15.0 to 27.0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        RT-PCR-confirmed RSV ARI, Season 2
    99999 (99999 to 99999)
    16.0 (12.0 to 24.0)
    14.0 (10.0 to 23.0)
    13.0 (9.0 to 18.0)
        RT-PCR-confirmed RSV LRTD, Season 2
    99999 (99999 to 99999)
    16.0 (13.0 to 24.0)
    17.0 (10.0 to 28.0)
    14.0 (9.0 to 23.0)
        RT-PCR-confirmed RSV ARI, Season 3
    99999 (99999 to 99999)
    16.0 (14.0 to 22.0)
    16.0 (13.0 to 24.0)
    10.0 (7.0 to 21.0)
        RT-PCR-confirmed RSV LRTD, Season 3
    99999 (99999 to 99999)
    17.5 (14.5 to 26.0)
    16.5 (15.0 to 24.5)
    12.0 (7.0 to 21.0)
    No statistical analyses for this end point

    Secondary: Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B ARI episodes during Season 1

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    End point title
    Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B ARI episodes during Season 1
    End point description
    RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route. Analysis was performed on the mES. Only participants withdata available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From post-dose 1 administration up to end of Season 1 in SH (assessed for approximately 6 months per participant)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    40
    110
    Units: Participants
        Nasal Congestion
    28
    83
        Rhinorrhea
    32
    93
        Sore Throat
    26
    76
        Cough (new or increased)
    36
    101
        Sputum (new or increased)
    20
    75
        Shortness of breath or dyspnea (new or increased)
    7
    35
        Wheezing (new or increased)
    5
    25
        Crackles
    1
    6
        Rhonchi
    1
    13
        Respiratory rate ≥20 breaths/minute
    3
    11
        Low or decreased oxygen saturation
    1
    9
        Fever
    2
    8
        Feverishness
    8
    24
        Fatigue
    22
    67
        Body aches
    12
    40
        Headache
    20
    55
        Decreased appetite
    13
    42
        Need for oxygen supplementation
    0
    4
        Need for positive airway pressure therapy
    0
    0
        Need of other types of mechanical ventilation
    0
    0
        Other symptoms or signs
    7
    22
    No statistical analyses for this end point

    Secondary: Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B ARI episodes during Season 2

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    End point title
    Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B ARI episodes during Season 2 [60]
    End point description
    RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route. Analysis was performed on the modified Exposed set for Dose 2 (mES-Dose 2), which included all participants who received the first and second doses of the study intervention, and who did not report an RSV-confirmed ARI prior to Day 15 after each vaccination. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From post-dose 2 administration up to end of Season 2 in SH (assessed for approximately 6 months per participant)
    Notes
    [60] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    208
    61
    45
    Units: Participants
        Nasal Congestion
    162
    43
    31
        Rhinorrhea
    186
    52
    39
        Sore Throat
    147
    43
    33
        Cough (new or increased)
    201
    55
    41
        Sputum (new or increased)
    150
    39
    29
        Shortness of breath or dyspnea (new or increased)
    79
    17
    19
        Wheezing (new or increased)
    56
    15
    10
        Crackles
    19
    2
    3
        Rhonchi
    32
    8
    7
        Respiratory rate ≥20 breaths/minute
    21
    5
    0
        Low or decreased oxygen saturation
    8
    1
    4
        Fever
    21
    5
    7
        Feverishness
    64
    13
    15
        Fatigue
    145
    34
    33
        Body aches
    91
    27
    24
        Headache
    124
    36
    28
        Decreased appetite
    85
    20
    18
        Need for oxygen supplementation
    1
    1
    0
        Need for positive airway pressure therapy
    0
    1
    0
        Need of other types of mechanical ventilation
    0
    0
    0
        Other symptoms or signs
    48
    12
    14
    No statistical analyses for this end point

    Secondary: Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B ARI episodes during Season 3

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    End point title
    Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B ARI episodes during Season 3 [61]
    End point description
    RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes were reported. Fever was defined as a temperature ≥38.0 degrees Celsius (°C) by any route. Analysis was performed on the mES-Dose 2. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B ARI episodes at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From start of Season 3 up to end of Season 3 in NH (assessed for approximately 6.7 months per participant)
    Notes
    [61] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    113
    30
    19
    Units: Participants
        Nasal Congestion
    101
    25
    15
        Rhinorrhea
    98
    26
    17
        Sore Throat
    76
    17
    14
        Cough (new or increased)
    111
    27
    18
        Sputum (new or increased)
    86
    23
    10
        Shortness of breath or dyspnea (new or increased)
    42
    10
    5
        Wheezing (new or increased)
    32
    6
    3
        Crackles
    10
    2
    0
        Rhonchi
    16
    8
    2
        Respiratory rate ≥20 breaths/minute
    9
    3
    0
        Low or decreased oxygen saturation
    11
    1
    3
        Fever
    10
    2
    0
        Feverishness
    32
    14
    6
        Fatigue
    85
    21
    15
        Body aches
    56
    16
    10
        Headache
    66
    16
    12
        Decreased appetite
    52
    13
    12
        Need for oxygen supplementation
    0
    1
    0
        Need for positive airway pressure therapy
    0
    0
    0
        Need of other types of mechanical ventilation
    0
    0
    0
        Other symptoms or signs
    35
    6
    9
    No statistical analyses for this end point

    Secondary: Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B LRTD episodes during Season 1

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    End point title
    Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B LRTD episodes during Season 1
    End point description
    RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route. Analysis was performed on the mES. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From post-dose 1 administration up to end of Season 1 in SH (assessed for approximately 6 months per participant)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    10
    47
    Units: Participants
        Nasal Congestion
    7
    38
        Rhinorrhea
    9
    38
        Sore Throat
    5
    33
        Cough (new or increased)
    10
    47
        Sputum (new or increased)
    8
    36
        Shortness of breath or dyspnea (new or increased)
    4
    29
        Wheezing (new or increased)
    5
    24
        Crackles
    1
    6
        Rhonchi
    0
    13
        Respiratory rate ≥20 breaths/minute
    3
    10
        Low or decreased oxygen saturation
    1
    8
        Fever
    1
    8
        Feverishness
    2
    16
        Fatigue
    6
    37
        Body aches
    5
    22
        Headache
    4
    27
        Decreased appetite
    7
    26
        Need for oxygen supplementation
    0
    4
        Need for positive airway pressure therapy
    0
    0
        Need of other types of mechanical ventilation
    0
    0
        Other symptoms or signs
    2
    12
    No statistical analyses for this end point

    Secondary: Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B LRTD episodes during Season 2

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    End point title
    Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B LRTD episodes during Season 2 [62]
    End point description
    RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route. Analysis was performed on the mES-Dose 2. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From post-dose 2 administration up to end of Season 2 in SH (assessed for approximately 6 months per participant)
    Notes
    [62] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    107
    22
    22
    Units: Participants
        Nasal Congestion
    90
    20
    15
        Rhinorrhea
    96
    20
    19
        Sore Throat
    79
    17
    15
        Cough (new or increased)
    106
    21
    20
        Sputum (new or increased)
    95
    19
    17
        Shortness of breath or dyspnea (new or increased)
    72
    14
    13
        Wheezing (new or increased)
    56
    15
    10
        Crackles
    19
    2
    3
        Rhonchi
    31
    5
    7
        Respiratory rate ≥20 breaths/minute
    21
    5
    0
        Low or decreased oxygen saturation
    8
    1
    4
        Fever
    13
    3
    3
        Feverishness
    44
    7
    8
        Fatigue
    86
    16
    15
        Body aches
    53
    15
    11
        Headache
    70
    17
    14
        Decreased appetite
    47
    13
    11
        Need for oxygen supplementation
    1
    1
    0
        Need for positive airway pressure therapy
    0
    1
    0
        Need of other types of mechanical ventilation
    0
    0
    0
        Other symptoms or signs
    28
    3
    5
    No statistical analyses for this end point

    Secondary: Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B LRTD episodes during Season 3

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    End point title
    Number of participants with each reported symptom/sign and supportive therapy use associated with of RT-PCR confirmed RSV A and/or B LRTD episodes during Season 3 [63]
    End point description
    RSV infection was confirmed by RT-PCR, and the symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes were reported. Fever was defined as a temperature ≥38.0°C by any route. Analysis was performed on the mES-Dose 2. Only participants with data available for symptoms/signs and supportive therapy use associated with RT-PCR confirmed RSV A and/or RSV B LRTD episodes at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From start of Season 3 up to end of Season 3 in NH (assessed for approximately 6.7 months per participant)
    Notes
    [63] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    61
    16
    6
    Units: Participants
        Nasal Congestion
    54
    13
    4
        Rhinorrhea
    50
    14
    4
        Sore Throat
    42
    9
    5
        Cough (new or increased)
    60
    15
    6
        Sputum (new or increased)
    53
    14
    5
        Shortness of breath or dyspnea (new or increased)
    38
    9
    4
        Wheezing (new or increased)
    32
    5
    3
        Crackles
    10
    2
    0
        Rhonchi
    16
    8
    2
        Respiratory rate ≥20 breaths/minute
    9
    3
    0
        Low or decreased oxygen saturation
    11
    1
    3
        Fever
    6
    0
    0
        Feverishness
    22
    8
    3
        Fatigue
    49
    13
    6
        Body aches
    39
    10
    5
        Headache
    41
    10
    5
        Decreased appetite
    33
    11
    3
        Need for oxygen supplementation
    0
    1
    0
        Need for positive airway pressure therapy
    0
    0
    0
        Need of other types of mechanical ventilation
    0
    0
    0
        Other symptoms or signs
    22
    4
    3
    No statistical analyses for this end point

    Secondary: Number of participants with RT-PCR confirmed RSV A and/or B ARI and LRTD episodes according to severity

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    End point title
    Number of participants with RT-PCR confirmed RSV A and/or B ARI and LRTD episodes according to severity
    End point description
    RSV A and/or B ARI and LRTD episodes were assessed as "mild", "moderate" or "severe" by the investigator after the single dose and after annual revaccination. Mild = an ARI/LRTD episode which is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. Moderate = an ARI/LRTD episode which is sufficiently discomforting to interfere with normal everyday activities. Severe = an ARI/LRTD episode which prevents normal, everyday activities. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    Assessed during the study period (approximately 3 years for NH and 2.5-3 years for SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12468
    12498
    Units: Participants
        Mild (Single dose)
    16
    49
        Moderate (Single dose)
    29
    138
        Severe (Single dose)
    3
    28
        Mild (Annual revaccination)
    15
    48
        Moderate (Annual revaccination)
    23
    120
        Severe (Annual revaccination)
    0
    24
    No statistical analyses for this end point

    Secondary: RSVPreF3 specific immunoglobulin G(IgG) antibody concentrations

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    End point title
    RSVPreF3 specific immunoglobulin G(IgG) antibody concentrations [64]
    End point description
    The RSVPreF3 IgG antibody concentrations are expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EU/mL). Analysis was performed in a subset of participants from the Per Protocol Set for immunogenicity (PPSi), which included participants who received at least the first dose of the study intervention to which they were randomized, have post-vaccination immunogenicity data available, and did not meet protocol deviations that lead to exclusion. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH)
    Notes
    [64] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    878
    441
    431
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Pre-dose 1 at day 1
    7090.2 (6783.4 to 7410.9)
    6956.5 (6505.2 to 7439.2)
    7101.1 (6640.7 to 7593.4)
        Post-dose 1 at day 31
    7053.2 (6732.0 to 7389.8)
    89361.9 (83409.6 to 95738.9)
    93769.5 (87896.6 to 100034.8)
        Pre-Season 2
    7594.8 (7203.9 to 8007.0)
    24103.6 (22366.8 to 25975.3)
    24523.8 (22748.7 to 26437.4)
        Pre-Season 3
    8436.6 (7927.3 to 8978.7)
    21255.0 (19587.7 to 23064.2)
    28925.3 (26928.0 to 31070.7)
    No statistical analyses for this end point

    Secondary: RSV A neutralizing antibody titers

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    End point title
    RSV A neutralizing antibody titers [65]
    End point description
    The RSV A neutralizing antibody titers are expressed as geometric mean titers (GMTs). Analysis was performed in a subset of participants from the PPSi. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH)
    Notes
    [65] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    878
    441
    431
    Units: Titers
    geometric mean (confidence interval 95%)
        Pre-dose 1 at day 1
    933.5 (881.8 to 988.4)
    899.8 (829.1 to 976.5)
    929.3 (852.6 to 1013.0)
        Post-dose 1 at day 31
    880.8 (828.9 to 935.9)
    8915.5 (8080.6 to 9836.8)
    9652.4 (8727.5 to 10675.3)
        Pre-Season 2
    865.8 (809.6 to 925.9)
    2535.9 (2284.7 to 2814.8)
    2918.4 (2594.5 to 3282.9)
        Pre-Season 3
    977.9 (905.5 to 1056.0)
    2049.7 (1841.0 to 2282.1)
    2996.1 (2665.3 to 3368.1)
    No statistical analyses for this end point

    Secondary: RSV B neutralizing antibody titers

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    End point title
    RSV B neutralizing antibody titers [66]
    End point description
    RSV B neutralizing antibodies are expressed as GMTs. Analysis was performed on PPSi. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    At pre-dose 1 (Day 1), Day 31 post-dose 1, pre-season 2 (approximately 10-17 months post Day 1 in NH; 12-21 months post Day 1 in SH) and pre-season 3 (approximately 24-27 months post Day 1, only in NH)
    Notes
    [66] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    878
    441
    431
    Units: Titers
    geometric mean (confidence interval 95%)
        Pre-dose 1 at day 1
    1249.7 (1179.1 to 1324.5)
    1189.9 (1097.4 to 1290.2)
    1187.2 (1096.7 to 1285.2)
        Post-dose 1 at day 31
    1262.4 (1183.8 to 1346.2)
    9928.9 (9103.7 to 10829.0)
    10253.4 (9362.7 to 11228.9)
        Pre-Season 2
    1229.7 (1149.9 to 1315.1)
    2955.5 (2677.0 to 3262.9)
    2979.2 (2692.2 to 3296.9)
        Pre-Season 3
    946.8 (873.5 to 1026.3)
    2054.5 (1829.9 to 2306.5)
    2515.3 (2249.9 to 2812.0)
    No statistical analyses for this end point

    Secondary: Number of participants with any and grade 3 solicited administration site adverse events

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    End point title
    Number of participants with any and grade 3 solicited administration site adverse events [67]
    End point description
    Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade or relation to study vaccination. Grade 3 = an event which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. Analysis was performed on a subset of participants from the solicited safety set (SSS), which included participants who received at least the first dose of the study intervention and with the solicited administration site events diary card data available after the corresponding vaccination for the specified duration. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
    Notes
    [67] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    874
    442
    437
    Units: Participants
        Erythema, Dose 1, Any
    10
    41
    30
        Erythema, Dose 1, Grade 3
    0
    0
    2
        Erythema, Dose 2, Any
    1
    1
    31
        Erythema , Dose 2, Grade 3
    0
    0
    3
        Erythema, Dose 3 (NH), Any
    0
    0
    2
        Erythema, Dose 3 (NH), Grade 3
    0
    0
    1
        Pain, Dose 1, Any
    81
    267
    268
        Pain, Dose 1, Grade 3
    0
    6
    3
        Pain, Dose 2, Any
    51
    30
    169
        Pain, Dose 2, Grade 3
    0
    0
    2
        Pain, Dose 3 (NH), Any
    7
    3
    25
        Pain, Dose 3 (NH), Grade 3
    0
    0
    0
        Swelling, Dose 1, Any
    7
    25
    28
        Swelling, Dose 1, Grade 3
    0
    0
    2
        Swelling, Dose 2, Any
    2
    0
    23
        Swelling, Dose 2, Grade 3
    0
    0
    6
        Swelling, Dose 3 (NH), Any
    0
    1
    2
        Swelling, Dose 3 (NH), Grade 3
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with any and grade 3 solicited systemic adverse events

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    End point title
    Number of participants with any and grade 3 solicited systemic adverse events [68]
    End point description
    Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade or relation to study vaccination. Grade 3 = an event which prevented normal, everyday activities. The assessed solicited systemic events include arthralgia, fatigue, fever, headache and myalgia. Fever is defined as a temperature ≥ 38.0°C by any route. Grade 3 fever is defined as temperature >39°C by any route. Analysis was performed on a subset of participants from the solicited safety set (SSS), which included participants who received at least the first dose of the study intervention and with the solicited systemic events diary card data available after the corresponding vaccination for the specified duration. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
    Notes
    [68] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    878
    442
    437
    Units: Participants
        Arthralgia, Dose 1, Any
    56
    74
    84
        Arthralgia, Dose 1, Grade 3
    5
    5
    6
        Arthralgia, Dose 2, Any
    48
    20
    55
        Arthralgia, Dose 2, Grade 3
    2
    0
    2
        Arthralgia, Dose 3 (NH), Any
    5
    2
    5
        Arthralgia, Dose 3 (NH), Grade 3
    0
    0
    0
        Fatigue, Dose 1, Any
    141
    143
    153
        Fatigue, Dose 1, Grade 3
    4
    6
    9
        Fatigue, Dose 2, Any
    80
    44
    98
        Fatigue, Dose 2, Grade 3
    7
    2
    3
        Fatigue, Dose 3 (NH), Any
    12
    8
    9
        Fatigue, Dose 3 (NH), Grade 3
    0
    1
    0
        Fever, Dose 1, Any
    3
    14
    4
        Fever, Dose 1, Grade 3
    1
    1
    0
        Fever, Dose 2, Any
    4
    1
    6
        Fever, Dose 2, Grade 3
    2
    0
    0
        Fever, Dose 3 (NH), Any
    1
    0
    0
        Fever, Dose 3 (NH), Grade 3
    0
    0
    0
        Headache, Dose 1, Any
    111
    116
    123
        Headache, Dose 1, Grade 3
    0
    6
    5
        Headache, Dose 2, Any
    60
    41
    73
        Headache, Dose 2, Grade 3
    4
    1
    2
        Headache, Dose 3 (NH), Any
    9
    6
    5
        Headache, Dose 3 (NH), Grade 3
    0
    0
    0
        Myalgia, Dose 1, Any
    72
    127
    128
        Myalgia, Dose 1, Grade 3
    3
    5
    7
        Myalgia, Dose 2, Any
    52
    20
    82
        Myalgia, Dose 2, Grade 3
    3
    0
    3
        Myalgia, Dose 3 (NH), Any
    5
    3
    7
        Myalgia, Dose 3 (NH), Grade 3
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of days with solicited administration site adverse events

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    End point title
    Number of days with solicited administration site adverse events [69]
    End point description
    Analysis was performed on a subset of participants from the solicited safety set (SSS), which included participants who received at least the first dose of the study intervention and with the solicited administration site events diary card data available after the corresponding vaccination for the specified duration. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
    Notes
    [69] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    81
    267
    268
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Erythema, Dose 1
    4.0 (2.0 to 4.0)
    3.0 (2.0 to 4.0)
    3.0 (2.0 to 4.0)
        Erythema, Dose 2
    4.0 (4.0 to 4.0)
    2.0 (2.0 to 2.0)
    3.0 (2.0 to 3.0)
        Erythema, Dose 3 (NH)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    3.0 (2.0 to 4.0)
        Pain, Dose 1
    1.0 (1.0 to 2.0)
    2.0 (1.0 to 3.0)
    2.0 (2.0 to 3.0)
        Pain, Dose 2
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
    2.0 (2.0 to 3.0)
        Pain, Dose 3 (NH)
    2.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
    2.0 (1.0 to 2.0)
        Swelling, Dose 1
    4.0 (2.0 to 8.0)
    3.0 (2.0 to 4.0)
    3.0 (2.0 to 4.5)
        Swelling, Dose 2
    2.0 (1.0 to 3.0)
    99999 (99999 to 99999)
    3.0 (2.0 to 4.0)
        Swelling, Dose 3 (NH)
    99999 (99999 to 99999)
    49.0 (49.0 to 49.0)
    1.5 (1.0 to 2.0)
    No statistical analyses for this end point

    Secondary: Number of days with solicited systemic adverse events

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    End point title
    Number of days with solicited systemic adverse events [70]
    End point description
    Analysis was performed on a subset of participants from the solicited safety set (SSS), which included participants who received at least the first dose of the study intervention and with the solicited systemic events diary card data available after the corresponding vaccination for the specified duration. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH])
    Notes
    [70] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    141
    143
    153
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Arthralgia, Dose 1
    2.5 (1.0 to 4.0)
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Arthralgia, Dose 2
    2.0 (1.0 to 4.0)
    2.0 (1.0 to 3.0)
    1.0 (1.0 to 3.0)
        Arthralgia, Dose 3 (NH)
    4.0 (3.0 to 4.0)
    2.0 (1.0 to 3.0)
    4.0 (1.0 to 4.0)
        Fatigue, Dose 1
    1.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Fatigue, Dose 2
    2.0 (1.0 to 4.0)
    1.5 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Fatigue, Dose 3 (NH)
    1.0 (1.0 to 2.0)
    2.5 (1.0 to 3.5)
    2.0 (1.0 to 2.0)
        Fever, Dose 1
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.5)
        Fever, Dose 2
    2.0 (1.5 to 3.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 4.0)
        Fever, Dose 3 (NH)
    1.0 (1.0 to 1.0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        Headache, Dose 1
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
        Headache, Dose 2
    2.0 (1.0 to 4.0)
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
        Headache, Dose 3 (NH)
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 1.0)
    2.0 (2.0 to 2.0)
        Myalgia, Dose 1
    1.5 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Myalgia, Dose 2
    2.0 (1.0 to 4.0)
    1.5 (1.0 to 2.0)
    2.0 (1.0 to 3.0)
        Myalgia, Dose 3 (NH)
    2.0 (1.0 to 3.0)
    3.0 (1.0 to 3.0)
    2.0 (1.0 to 4.0)
    No statistical analyses for this end point

    Secondary: Number of participants with any unsolicited AEs

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    End point title
    Number of participants with any unsolicited AEs [71]
    End point description
    An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside of the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any= occurrence of the event regardless of intensity grade or relation to the study vaccination. Analysis is performed on the Exposed Set, which included all participants that received at least the first vaccination. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    During the 30-day follow up period after first vaccination (Day 1), second vaccination (administered pre-season 2) and after the third vaccination (administered pre-season 3 -only applicable for participants in NH)
    Notes
    [71] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    12503
    6226
    6243
    Units: Participants
        Any unsolicited AE (post Dose 1)
    2334
    2149
    2136
        Any unsolicited AE (post Dose 2)
    1570
    824
    1456
        Any unsolicited AE (post Dose 3)
    422
    233
    397
    No statistical analyses for this end point

    Secondary: Number of participants with Serious Adverse Events (SAEs)

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    End point title
    Number of participants with Serious Adverse Events (SAEs) [72]
    End point description
    An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to study vaccination. Analysis is performed on the Exposed Set, which included all participants that received at least the first vaccination. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH])
    Notes
    [72] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    12503
    6226
    6243
    Units: Participants
        Any SAE (post Dose 1)
    541
    280
    268
        Any SAE (post Dose 2)
    497
    239
    229
        Any SAE (post Dose 3)
    179
    75
    73
    No statistical analyses for this end point

    Secondary: Number of participants with potential Immune Mediated Diseases (pIMDs)

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    End point title
    Number of participants with potential Immune Mediated Diseases (pIMDs) [73]
    End point description
    pIMDs aredefined as a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any= occurrence of any pIMD regardless of intensity grade or relation to the study vaccination. Analysis is performed on the Exposed Set, which included all participants that received at least the first vaccination. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    From the day of the vaccination up to 6 months after each vaccination (first vaccination: at Day 1, second vaccination: at pre-season 2 and the third vaccination: at pre-season 3 -only applicable for participants in NH])
    Notes
    [73] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    12503
    6226
    6243
    Units: Participants
        Any pIMDs (post Dose 1)
    39
    27
    19
        Any pIMDs (post Dose 2)
    39
    19
    14
        Any pIMDs (post Dose 3)
    13
    8
    10
    No statistical analyses for this end point

    Secondary: Number of participants with first episode of RT-PCR confirmed RSV subtype A and subtype B LRTD over 3 seasons following a single dose of the RSVPreF3 OA vaccine and following 1 annual revaccination dose

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    End point title
    Number of participants with first episode of RT-PCR confirmed RSV subtype A and subtype B LRTD over 3 seasons following a single dose of the RSVPreF3 OA vaccine and following 1 annual revaccination dose
    End point description
    Efficacy of a single dose and 1 annual revaccination dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post first vaccination up to end of season 3 in the NH (assessed approximately over 3 years in NH, and 2.5-3 years in SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12468
    12498
    Units: Participants
        RT-PCR-confirmed RSV-A LRTD
    17
    65
        RT-PCR-confirmed RSV-B LRTD
    21
    127
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [74]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    73.58
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    55.1
         upper limit
    85.4
    Notes
    [74] - VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [75]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    55.12
    Confidence interval
         level
    97.5%
         sides
    2-sided
         lower limit
    16.52
         upper limit
    77.52
    Notes
    [75] - VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.

    Secondary: Number of hospitalizations due to RSV-confirmed respiratory diseases or due to complication related to RSV-confirmed respiratory diseases, following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses up to end of study

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    End point title
    Number of hospitalizations due to RSV-confirmed respiratory diseases or due to complication related to RSV-confirmed respiratory diseases, following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses up to end of study
    End point description
    RSV infection was confirmed by RT-PCR. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis. Category 1 = Confirmed RSV respiratory disease, Category 2 = Confirmed RSV respiratory disease or complication related to confirmed RSV ARI.
    End point type
    Secondary
    End point timeframe
    From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12468
    12498
    Units: Participants
        Category 1 (Single dose), during seasons
    2
    4
        Category 2 (Single dose), during seasons
    2
    4
        Category 1 (Ann revaccination), during season
    0
    4
        Category 2 (Ann revaccination), during seasons
    0
    4
        Category 1 (Single dose), up to end of study
    2
    6
        Category 2 (Single dose), up to end of study
    2
    6
        Category 1 (Ann revaccination), up to end of study
    0
    6
        Category 2 (Ann revaccination), up to end of study
    0
    6
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [76]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    50.37
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -184.45
         upper limit
    95.19
    Notes
    [76] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [77]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    50.37
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -184.45
         upper limit
    95.19
    Notes
    [77] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [78]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.56
         upper limit
    100
    Notes
    [78] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [79]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.56
         upper limit
    100
    Notes
    [79] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    other [80]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -54.53
         upper limit
    100
    Notes
    [80] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statisitical analysis 5
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV seson in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    other [81]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    22.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -457.67
         upper limit
    93.12
    Notes
    [81] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    other [82]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -54.53
         upper limit
    100
    Notes
    [82] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    other [83]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    22.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -457.67
         upper limit
    93.12
    Notes
    [83] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with related pIMDs

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    End point title
    Number of participants with related pIMDs [84]
    End point description
    Related pIMD = pIMD assessed by the investigator as related to the study vaccination. Analysis was performed on the Exposed Set. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)
    Notes
    [84] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    12503
    6226
    6243
    Units: Participants
    9
    7
    5
    No statistical analyses for this end point

    Secondary: Number of hospitalizations due to any respiratory diseases or due to a complication related to any respiratory diseases, during the RSV seasons following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses up to end of study

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    End point title
    Number of hospitalizations due to any respiratory diseases or due to a complication related to any respiratory diseases, during the RSV seasons following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses up to end of study
    End point description
    A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. Analysis was performed on the Exposed set, which included all participants who received at least the first dose of the study intervention. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12469
    12503
    Units: Participants
        Any respiratory disease (Single dose)
    167
    221
        Any respiratory disease/complication(Single dose)
    179
    230
        Any respiratory disease (Ann revaccination)
    163
    208
        Any respiratory disease/complication(Ann revacc)
    171
    217
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    [85]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    -1.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -25.43
         upper limit
    17.49
    Notes
    [85] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    [86]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    -3.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -25.43
         upper limit
    17.49
    Notes
    [86] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    [87]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    -3.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -27.55
         upper limit
    15.98
    Notes
    [87] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    [88]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    -4.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.26
         upper limit
    14.61
    Notes
    [88] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of complications related to any ARI during the RSV seasons following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses up to end of study

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    End point title
    Number of complications related to any ARI during the RSV seasons following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses up to end of study
    End point description
    RSV infection was confirmed by RT-PCR. Analysis was performed on the Exposed set. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12469
    12503
    Units: Participants
        Single dose
    620
    863
        Annual revaccination
    579
    823
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    [89]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    6.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.05
         upper limit
    16.39
    Notes
    [89] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24972
    Analysis specification
    Pre-specified
    Analysis type
    [90]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    2.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.29
         upper limit
    12.42
    Notes
    [90] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of complications related to RSV-confirmed ARI during the RSV seasons following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses up to end of study

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    End point title
    Number of complications related to RSV-confirmed ARI during the RSV seasons following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses up to end of study
    End point description
    RSV infection was confirmed by RT-PCR. Analysis was performed on the mES-RSV. Only participants with data available at specified timepoints were included in analysis.
    End point type
    Secondary
    End point timeframe
    From Day 15 post-first vaccination up to study end (approximately 3 years for NH and 2.5-3 years for SH)
    End point values
    RSVPreF3 Group Placebo Group
    Number of subjects analysed
    12468
    12498
    Units: Participants
        RSV ARI (Single dose)
    12
    50
        RSV ARI (Annual revaccination)
    11
    46
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [91]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    63.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.5
         upper limit
    83.2
    Notes
    [91] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.
    Comparison groups
    RSVPreF3 Group v Placebo Group
    Number of subjects included in analysis
    24966
    Analysis specification
    Pre-specified
    Analysis type
    [92]
    Method
    Poisson regression method
    Parameter type
    VE
    Point estimate
    62.94
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.91
         upper limit
    82.15
    Notes
    [92] - The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.

    Secondary: Number of participants with related SAEs

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    End point title
    Number of participants with related SAEs [93]
    End point description
    Related SAEs that occur throughout the study are assessed. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Analysis was performed on the Exposed Set. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)
    Notes
    [93] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    12503
    6226
    6243
    Units: Participants
    12
    8
    12
    No statistical analyses for this end point

    Secondary: Number of participants with fatal SAEs

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    End point title
    Number of participants with fatal SAEs [94]
    End point description
    Fatal SAEs that occur throughout the study are assessed. Fatal SAEs= Any SAEs leading to deaths. Analysis was performed on the Exposed Set. Only participants with data available at specified timepoints were included in analysis. Analysis is presented dose-wise after first dose administration and annual revaccinations.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to study end (approximately 3 years for NH and 2.5-3 years for SH)
    Notes
    [94] - 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: Analysis is presented dose-wise after first dose administration and annual revaccinations, hence data was reported for the Placebo group, and RSV_1_dose and RSV_annual groups.
    End point values
    Placebo Group RSV_1_dose Group RSV_annual Group
    Number of subjects analysed
    12503
    6226
    6243
    Units: Participants
    265
    111
    120
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: Day 1(D)-D4 post vaccination,unsolicited AEs: D1-D30 post vaccination. SAEs, pIMDs: Day 1 to 6 months post any vaccination. All cause mortality, Fatal & Related SAEs,Related pIMDs: D1 to approximately 3 years for NH and 2.5-3 years for SH
    Adverse event reporting additional description
    All adverse events are presented for the Exposed set, which included all participants that received at least one study intervention.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Placebo Group
    Reporting group description
    Participants received 1 dose of placebo at Day 1 and an additional dose of placebo every subsequent year.

    Reporting group title
    RSV_1_dose Group
    Reporting group description
    Participants received a dose of placebo every subsequent year.

    Reporting group title
    RSV_annual Group
    Reporting group description
    Participants received an additional dose of RSVPreF3 OA vaccine every subsequent year

    Serious adverse events
    Placebo Group RSV_1_dose Group RSV_annual Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1660 / 12503 (13.28%)
    799 / 6226 (12.83%)
    796 / 6243 (12.75%)
         number of deaths (all causes)
    265
    111
    120
         number of deaths resulting from adverse events
    2
    2
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    8 / 12503 (0.06%)
    9 / 6226 (0.14%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    Prostate cancer
         subjects affected / exposed
    39 / 12503 (0.31%)
    20 / 6226 (0.32%)
    15 / 6243 (0.24%)
         occurrences causally related to treatment / all
    0 / 39
    0 / 20
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    21 / 12503 (0.17%)
    10 / 6226 (0.16%)
    10 / 6243 (0.16%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    13 / 12503 (0.10%)
    7 / 6226 (0.11%)
    7 / 6243 (0.11%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
    Pancreatic carcinoma
         subjects affected / exposed
    11 / 12503 (0.09%)
    6 / 6226 (0.10%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
    Basal cell carcinoma
         subjects affected / exposed
    8 / 12503 (0.06%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    2 / 12503 (0.02%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    4 / 12503 (0.03%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    3 / 12503 (0.02%)
    4 / 6226 (0.06%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    6 / 12503 (0.05%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Lung cancer metastatic
         subjects affected / exposed
    2 / 12503 (0.02%)
    4 / 6226 (0.06%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Metastases to liver
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Metastases to lymph nodes
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Brain neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Breast cancer metastatic
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Clear cell renal cell carcinoma
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Renal cancer
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal carcinoma
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Prostatic adenoma
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Throat cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paget's disease of nipple
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acoustic neuroma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder papilloma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angiosarcoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct adenocarcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of appendix
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholesteatoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic myelomonocytic leukaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer recurrent
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer stage III
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cancer pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma recurrent
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Borderline ovarian tumour
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Breast cancer stage IV
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer metastatic
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Endometrial cancer stage II
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypopharyngeal cancer stage IV
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Essential thrombocythaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extranodal marginal zone B-cell lymphoma (MALT type)
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fallopian tube neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Follicular lymphoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Follicular lymphoma stage IV
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer stage IV
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal lymphoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head and neck cancer stage III
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer stage I
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraductal papillary-mucinous carcinoma of pancreas
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leiomyosarcoma metastatic
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mediastinum neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medullary thyroid cancer
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to bladder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to chest wall
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to nervous system
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Metastases to pancreas
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma stage IV
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metastases to pelvis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to rectum
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer stage III
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic renal cell carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myxoid liposarcoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Neurofibroma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic lymphoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Squamous cell carcinoma of the hypopharynx
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomyxoma peritonei
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cancer recurrent
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schwannoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue sarcoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Spindle cell sarcoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteral neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulval cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    11 / 12503 (0.09%)
    7 / 6226 (0.11%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    11 / 12503 (0.09%)
    0 / 6226 (0.00%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    3 / 12503 (0.02%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Peripheral ischaemia
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
    Haematoma
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Giant cell arteritis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aneurysm ruptured
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iliac artery occlusion
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Shock haemorrhagic
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accelerated hypertension
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aneurysm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial rupture
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scalp haematoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subclavian steal syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subclavian vein thrombosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Assisted suicide
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    54 / 12503 (0.43%)
    18 / 6226 (0.29%)
    28 / 6243 (0.45%)
         occurrences causally related to treatment / all
    1 / 54
    0 / 18
    0 / 28
         deaths causally related to treatment / all
    1 / 54
    0 / 18
    0 / 28
    Chest pain
         subjects affected / exposed
    17 / 12503 (0.14%)
    11 / 6226 (0.18%)
    13 / 6243 (0.21%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    6 / 12503 (0.05%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 6
    0 / 2
    0 / 2
    Asthenia
         subjects affected / exposed
    8 / 12503 (0.06%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    6 / 12503 (0.05%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 6
    0 / 1
    0 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    Impaired healing
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Accidental death
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Adverse drug reaction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Cyst rupture
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Drug resistance
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gait inability
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Ill-defined disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nodule
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstruction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Primary amyloidosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anti-neutrophil cytoplasmic antibody positive vasculitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    13 / 12503 (0.10%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Genital prolapse
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adnexa uteri cyst
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast hyperplasia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic organ prolapse
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic dysplasia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic obstruction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal swelling
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    38 / 12503 (0.30%)
    24 / 6226 (0.39%)
    18 / 6243 (0.29%)
         occurrences causally related to treatment / all
    0 / 53
    0 / 28
    0 / 23
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    31 / 12503 (0.25%)
    6 / 6226 (0.10%)
    15 / 6243 (0.24%)
         occurrences causally related to treatment / all
    3 / 31
    0 / 6
    1 / 15
         deaths causally related to treatment / all
    1 / 5
    0 / 1
    0 / 3
    Acute respiratory failure
         subjects affected / exposed
    10 / 12503 (0.08%)
    5 / 6226 (0.08%)
    6 / 6243 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Dyspnoea
         subjects affected / exposed
    10 / 12503 (0.08%)
    5 / 6226 (0.08%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    8 / 12503 (0.06%)
    3 / 6226 (0.05%)
    6 / 6243 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    9 / 12503 (0.07%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    9 / 12503 (0.07%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
    Pneumothorax
         subjects affected / exposed
    8 / 12503 (0.06%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Dyspnoea exertional
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Pleurisy
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary thrombosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Asthma late onset
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma-chronic obstructive pulmonary disease overlap syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Choking
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Laryngeal polyp
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung perforation
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mediastinal mass
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Middle lobe syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal polyp
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sputum discoloured
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    8 / 12503 (0.06%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Alcoholism
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adjustment disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conversion disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depressed mood
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gender dysphoria
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucinations, mixed
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Substance-induced mood disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device loosening
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device breakage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    21 / 12503 (0.17%)
    4 / 6226 (0.06%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    9 / 12503 (0.07%)
    4 / 6226 (0.06%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    8 / 12503 (0.06%)
    3 / 6226 (0.05%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Biliary tract disorder
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder rupture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Hepatic failure
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Biliary dilatation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cholelithiasis obstructive
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood pressure increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood electrolytes abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    International normalised ratio fluctuation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial necrosis marker increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulse absent
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    17 / 12503 (0.14%)
    8 / 6226 (0.13%)
    9 / 6243 (0.14%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Hip fracture
         subjects affected / exposed
    14 / 12503 (0.11%)
    9 / 6226 (0.14%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Femur fracture
         subjects affected / exposed
    10 / 12503 (0.08%)
    7 / 6226 (0.11%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Rib fracture
         subjects affected / exposed
    11 / 12503 (0.09%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    10 / 12503 (0.08%)
    4 / 6226 (0.06%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    8 / 12503 (0.06%)
    5 / 6226 (0.08%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    9 / 12503 (0.07%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    5 / 12503 (0.04%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Tibia fracture
         subjects affected / exposed
    7 / 12503 (0.06%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Hand fracture
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shoulder fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Jaw fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural hypotension
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scapula fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniofacial fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniofacial injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dislocation of vertebra
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Flail chest
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body in eye
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypobarism
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kidney rupture
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural fever
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural inflammation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative hypertension
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiation injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiation pneumonitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Respiratory fume inhalation disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Splenic injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic arthrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Trunk injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulnar nerve injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract procedural complication
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Phimosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hereditary non-polyposis colorectal cancer syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hereditary haemorrhagic telangiectasia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Corneal dystrophy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    66 / 12503 (0.53%)
    22 / 6226 (0.35%)
    31 / 6243 (0.50%)
         occurrences causally related to treatment / all
    2 / 77
    0 / 22
    1 / 35
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    54 / 12503 (0.43%)
    17 / 6226 (0.27%)
    16 / 6243 (0.26%)
         occurrences causally related to treatment / all
    1 / 56
    0 / 18
    0 / 16
         deaths causally related to treatment / all
    0 / 15
    0 / 8
    0 / 7
    Coronary artery disease
         subjects affected / exposed
    37 / 12503 (0.30%)
    7 / 6226 (0.11%)
    18 / 6243 (0.29%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 8
    0 / 20
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    Acute myocardial infarction
         subjects affected / exposed
    27 / 12503 (0.22%)
    13 / 6226 (0.21%)
    15 / 6243 (0.24%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 13
    1 / 16
         deaths causally related to treatment / all
    0 / 5
    0 / 1
    0 / 2
    Cardiac failure
         subjects affected / exposed
    29 / 12503 (0.23%)
    12 / 6226 (0.19%)
    14 / 6243 (0.22%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 14
    0 / 15
         deaths causally related to treatment / all
    0 / 9
    0 / 4
    0 / 3
    Cardiac failure congestive
         subjects affected / exposed
    20 / 12503 (0.16%)
    14 / 6226 (0.22%)
    10 / 6243 (0.16%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    0 / 2
    Angina pectoris
         subjects affected / exposed
    10 / 12503 (0.08%)
    8 / 6226 (0.13%)
    7 / 6243 (0.11%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    16 / 12503 (0.13%)
    3 / 6226 (0.05%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    14 / 12503 (0.11%)
    6 / 6226 (0.10%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 14
    1 / 6
    0 / 3
    Aortic valve stenosis
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Atrial flutter
         subjects affected / exposed
    6 / 12503 (0.05%)
    6 / 6226 (0.10%)
    6 / 6243 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    Acute coronary syndrome
         subjects affected / exposed
    4 / 12503 (0.03%)
    5 / 6226 (0.08%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    6 / 12503 (0.05%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    6 / 12503 (0.05%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    13 / 12503 (0.10%)
    2 / 6226 (0.03%)
    6 / 6243 (0.10%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    Bradycardia
         subjects affected / exposed
    6 / 12503 (0.05%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    3 / 12503 (0.02%)
    4 / 6226 (0.06%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Coronary artery stenosis
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Pericarditis
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dilated cardiomyopathy
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Heart failure with reduced ejection fraction
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Palpitations
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    Aortic valve incompetence
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiomegaly
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chordae tendinae rupture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery aneurysm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery embolism
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiorenal syndrome
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Chronic coronary syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heart failure with preserved ejection fraction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve calcification
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paroxysmal atrioventricular block
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    46 / 12503 (0.37%)
    15 / 6226 (0.24%)
    22 / 6243 (0.35%)
         occurrences causally related to treatment / all
    0 / 47
    0 / 15
    1 / 22
         deaths causally related to treatment / all
    0 / 7
    0 / 3
    0 / 3
    Syncope
         subjects affected / exposed
    21 / 12503 (0.17%)
    22 / 6226 (0.35%)
    13 / 6243 (0.21%)
         occurrences causally related to treatment / all
    0 / 21
    1 / 22
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    26 / 12503 (0.21%)
    7 / 6226 (0.11%)
    10 / 6243 (0.16%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 7
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    8 / 12503 (0.06%)
    6 / 6226 (0.10%)
    7 / 6243 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    7 / 12503 (0.06%)
    4 / 6226 (0.06%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    Dizziness
         subjects affected / exposed
    4 / 12503 (0.03%)
    6 / 6226 (0.10%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    8 / 12503 (0.06%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Sciatica
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral arteriosclerosis
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amnesia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arachnoiditis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Autonomic nervous system imbalance
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bell's palsy
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain stem haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Brain stem stroke
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral venous sinus thrombosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fistula
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cervical cord compression
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Demyelinating polyneuropathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diplegia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness postural
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dural arteriovenous fistula
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental impairment
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myelin oligodendrocyte glycoprotein antibody-associated disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroleptic malignant syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Occipital lobe stroke
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Occipital neuralgia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peroneal nerve palsy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychogenic seizure
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Senile dementia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic radiculopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombotic stroke
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Tremor
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebral artery occlusion
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar artery dissection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar stroke
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    12 / 12503 (0.10%)
    6 / 6226 (0.10%)
    6 / 6243 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Increased tendency to bruise
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Neurosensory hypoacusis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deafness
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    14 / 12503 (0.11%)
    6 / 6226 (0.10%)
    10 / 6243 (0.16%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ocular myasthenia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blepharochalasis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blindness
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blindness transient
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Corneal decompensation
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Corneal erosion
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Episcleritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eyelid cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinoschisis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    13 / 12503 (0.10%)
    5 / 6226 (0.08%)
    8 / 6243 (0.13%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    8 / 12503 (0.06%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    7 / 12503 (0.06%)
    7 / 6226 (0.11%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Small intestinal obstruction
         subjects affected / exposed
    5 / 12503 (0.04%)
    6 / 6226 (0.10%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Gastritis
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    7 / 6243 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    6 / 12503 (0.05%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Abdominal pain
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Constipation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Peptic ulcer perforation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Acute abdomen
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendix disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coeliac artery compression syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis haemorrhagic
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epiploic appendagitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal necrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal vascular malformation haemorrhagic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedematous pancreatitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal fistula
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Oesophageal mucosal tear
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic failure
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Salivary gland calculus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Superior mesenteric artery syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Thrombosis mesenteric vessel
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Tooth impacted
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Actinic keratosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin lesion
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous emphysema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blister
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermal cyst
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Henoch-Schonlein purpura
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity vasculitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pemphigus
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash vesicular
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stasis dermatitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Superficial inflammatory dermatosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    18 / 12503 (0.14%)
    12 / 6226 (0.19%)
    14 / 6243 (0.22%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 12
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Nephrolithiasis
         subjects affected / exposed
    8 / 12503 (0.06%)
    5 / 6226 (0.08%)
    7 / 6243 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    Ureterolithiasis
         subjects affected / exposed
    6 / 12503 (0.05%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    8 / 12503 (0.06%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Haematuria
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder stenosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder tamponade
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive nephropathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteral necrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adrenal mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cushing's syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pituitary-dependent Cushing's syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    48 / 12503 (0.38%)
    38 / 6226 (0.61%)
    21 / 6243 (0.34%)
         occurrences causally related to treatment / all
    0 / 52
    0 / 41
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    7 / 6243 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    7 / 12503 (0.06%)
    4 / 6226 (0.06%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    2 / 12503 (0.02%)
    4 / 6226 (0.06%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chondrocalcinosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone lesion
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diastasis recti abdominis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff tear arthropathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sacral pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Spinal synovial cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    80 / 12503 (0.64%)
    37 / 6226 (0.59%)
    34 / 6243 (0.54%)
         occurrences causally related to treatment / all
    0 / 84
    0 / 42
    0 / 35
         deaths causally related to treatment / all
    0 / 10
    0 / 3
    0 / 5
    Cellulitis
         subjects affected / exposed
    12 / 12503 (0.10%)
    5 / 6226 (0.08%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    22 / 12503 (0.18%)
    9 / 6226 (0.14%)
    13 / 6243 (0.21%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 9
    0 / 13
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    0 / 5
    Urinary tract infection
         subjects affected / exposed
    17 / 12503 (0.14%)
    9 / 6226 (0.14%)
    11 / 6243 (0.18%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    34 / 12503 (0.27%)
    21 / 6226 (0.34%)
    19 / 6243 (0.30%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 21
    0 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    0 / 5
    COVID-19 pneumonia
         subjects affected / exposed
    26 / 12503 (0.21%)
    15 / 6226 (0.24%)
    14 / 6243 (0.22%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 15
    0 / 15
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    0 / 2
    Diverticulitis
         subjects affected / exposed
    9 / 12503 (0.07%)
    5 / 6226 (0.08%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    7 / 12503 (0.06%)
    4 / 6226 (0.06%)
    7 / 6243 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 12503 (0.04%)
    7 / 6226 (0.11%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Appendicitis
         subjects affected / exposed
    5 / 12503 (0.04%)
    5 / 6226 (0.08%)
    6 / 6243 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    4 / 12503 (0.03%)
    8 / 6226 (0.13%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Bronchitis
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Influenza
         subjects affected / exposed
    7 / 12503 (0.06%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    6 / 12503 (0.05%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    6 / 12503 (0.05%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    5 / 12503 (0.04%)
    5 / 6226 (0.08%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    0 / 1
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    6 / 12503 (0.05%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Pyelonephritis acute
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Respiratory tract infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atypical mycobacterial infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Bursitis infective
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis intestinal perforated
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gangrene
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blister infected
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nosocomial infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Abdominal wall abscess
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoas abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Candida pneumonia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Capnocytophaga sepsis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac valve vegetation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis streptococcal
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coccidioidomycosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis staphylococcal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extradural abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer helicobacter
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Giardiasis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis infectious mononucleosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Human anaplasmosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incision site abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of asthma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Joint abscess
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective aortitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory moniliasis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Submandibular abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic shock syndrome streptococcal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal cellulitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    6 / 12503 (0.05%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    6 / 12503 (0.05%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    6 / 12503 (0.05%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    6 / 12503 (0.05%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic complication
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acidosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Euglycaemic diabetic ketoacidosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperchloraemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo Group RSV_1_dose Group RSV_annual Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5837 / 12503 (46.68%)
    3663 / 6226 (58.83%)
    3826 / 6243 (61.28%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    21 / 12503 (0.17%)
    21 / 6226 (0.34%)
    15 / 6243 (0.24%)
         occurrences all number
    21
    23
    15
    B-cell lymphoma
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    11 / 12503 (0.09%)
    6 / 6226 (0.10%)
    3 / 6243 (0.05%)
         occurrences all number
    11
    6
    3
    Squamous cell carcinoma
         subjects affected / exposed
    8 / 12503 (0.06%)
    5 / 6226 (0.08%)
    4 / 6243 (0.06%)
         occurrences all number
    8
    5
    4
    Malignant melanoma
         subjects affected / exposed
    8 / 12503 (0.06%)
    3 / 6226 (0.05%)
    4 / 6243 (0.06%)
         occurrences all number
    8
    3
    4
    Breast cancer
         subjects affected / exposed
    9 / 12503 (0.07%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    9
    0
    2
    Lipoma
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    3
    2
    Skin cancer
         subjects affected / exposed
    4 / 12503 (0.03%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    4
    2
    Seborrhoeic keratosis
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    4
    1
    3
    Melanocytic naevus
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    4
    0
    3
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    2
    2
    Skin papilloma
         subjects affected / exposed
    1 / 12503 (0.01%)
    4 / 6226 (0.06%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    4
    0
    Bladder cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    1
    2
    Invasive ductal breast carcinoma
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Metastases to bone
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Myelodysplastic syndrome
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    2
    0
    Prostate cancer recurrent
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    1
    0
    Bladder neoplasm
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Colon cancer
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Colorectal adenoma
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    1
    2
    Prostate cancer
         subjects affected / exposed
    19 / 12503 (0.15%)
    11 / 6226 (0.18%)
    7 / 6243 (0.11%)
         occurrences all number
    19
    11
    7
    Benign breast neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Benign hepatic neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Benign soft tissue neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Bowen's disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Dysplastic naevus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Fibrous histiocytoma
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Lung adenocarcinoma
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Lung neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Neoplasm malignant
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Plasma cell myeloma
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Throat cancer
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Adenocarcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Adenoid cystic carcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Adenoma benign
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    B-cell type acute leukaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Basosquamous carcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Benign neoplasm of adrenal gland
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Haemangioma of liver
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Haemangioma of bone
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hairy cell leukaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    High-grade B-cell lymphoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bladder papilloma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bone neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Carcinoid tumour pulmonary
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Chronic lymphocytic leukaemia stage 1
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Colon neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Ear neoplasm malignant
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Extranodal marginal zone B-cell lymphoma (MALT type)
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Fibroadenoma of breast
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Haemangioma of skin
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pancreatic neuroendocrine tumour
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Keratoacanthoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Lentigo maligna
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Lip neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Lipoma of breast
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Lung cancer metastatic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Lung carcinoma cell type unspecified stage III
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Metastases to lung
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Monoclonal gammopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Mucinous breast carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Neuroendocrine carcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Neurofibroma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Ocular melanoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Oesophageal neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Oral papilloma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Prostate cancer stage I
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Prostate cancer stage II
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Prostate cancer stage IV
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Prostatic adenoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Renal adenoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Renal cancer metastatic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Renal hamartoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Renal neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Skull base tumour
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Small cell lung cancer limited stage
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Spindle cell sarcoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Splenic marginal zone lymphoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Squamous cell carcinoma of head and neck
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Thyroid cancer metastatic
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Thyroid neoplasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Urethral cancer
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Uterine cancer
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Polycythaemia vera
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Waldenstrom's macroglobulinaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    1
    2
    Hypertensive crisis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    1
    3
    Flushing
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    2
    1
    4
    Aortic stenosis
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    2
    1
    Aortic arteriosclerosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    2
    2
    Aortic aneurysm
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    2
    1
    Thrombosis
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    1
    2
    Varicose vein
         subjects affected / exposed
    7 / 12503 (0.06%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    7
    1
    1
    Peripheral venous disease
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    7
    2
    2
    Peripheral vascular disorder
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    7
    2
    2
    Peripheral arterial occlusive disease
         subjects affected / exposed
    6 / 12503 (0.05%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    6
    5
    2
    Deep vein thrombosis
         subjects affected / exposed
    8 / 12503 (0.06%)
    6 / 6226 (0.10%)
    4 / 6243 (0.06%)
         occurrences all number
    8
    6
    4
    Hot flush
         subjects affected / exposed
    7 / 12503 (0.06%)
    8 / 6226 (0.13%)
    5 / 6243 (0.08%)
         occurrences all number
    7
    8
    5
    Haematoma
         subjects affected / exposed
    14 / 12503 (0.11%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences all number
    14
    2
    5
    Hypotension
         subjects affected / exposed
    19 / 12503 (0.15%)
    9 / 6226 (0.14%)
    7 / 6243 (0.11%)
         occurrences all number
    20
    10
    7
    Hypertension
         subjects affected / exposed
    246 / 12503 (1.97%)
    110 / 6226 (1.77%)
    107 / 6243 (1.71%)
         occurrences all number
    250
    111
    110
    Lymphoedema
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    0
    3
    Superficial vein thrombosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Phlebitis superficial
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Phlebectasia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Peripheral ischaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Microscopic polyangiitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Hypertensive urgency
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Embolism
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure inadequately controlled
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Bleeding varicose vein
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Aortic disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Peripheral artery occlusion
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Intermittent claudication
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Aortic dilatation
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    White coat hypertension
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Raynaud's phenomenon
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Giant cell arteritis
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    0
    1
    3
    Essential hypertension
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    0
    2
    Blood pressure fluctuation
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    2
    0
    Arteriosclerosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    0
    1
    3
    Thrombophlebitis
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    1
    1
    Orthostatic hypotension
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    3
    0
    Subclavian steal syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Systolic hypertension
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vasodilatation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Varicose ulceration
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    424 / 12503 (3.39%)
    1379 / 6226 (22.15%)
    1713 / 6243 (27.44%)
         occurrences all number
    469
    1462
    2257
    Fatigue
         subjects affected / exposed
    410 / 12503 (3.28%)
    394 / 6226 (6.33%)
    453 / 6243 (7.26%)
         occurrences all number
    469
    446
    541
    Pyrexia
         subjects affected / exposed
    85 / 12503 (0.68%)
    144 / 6226 (2.31%)
    197 / 6243 (3.16%)
         occurrences all number
    89
    149
    217
    Injection site swelling
         subjects affected / exposed
    38 / 12503 (0.30%)
    208 / 6226 (3.34%)
    347 / 6243 (5.56%)
         occurrences all number
    38
    211
    406
    Injection site erythema
         subjects affected / exposed
    56 / 12503 (0.45%)
    291 / 6226 (4.67%)
    449 / 6243 (7.19%)
         occurrences all number
    60
    299
    522
    Pain
         subjects affected / exposed
    76 / 12503 (0.61%)
    76 / 6226 (1.22%)
    120 / 6243 (1.92%)
         occurrences all number
    78
    76
    129
    Chills
         subjects affected / exposed
    46 / 12503 (0.37%)
    45 / 6226 (0.72%)
    104 / 6243 (1.67%)
         occurrences all number
    51
    45
    113
    Vaccination site pain
         subjects affected / exposed
    18 / 12503 (0.14%)
    66 / 6226 (1.06%)
    86 / 6243 (1.38%)
         occurrences all number
    20
    67
    95
    Injection site joint pain
         subjects affected / exposed
    9 / 12503 (0.07%)
    37 / 6226 (0.59%)
    50 / 6243 (0.80%)
         occurrences all number
    9
    40
    52
    Malaise
         subjects affected / exposed
    34 / 12503 (0.27%)
    35 / 6226 (0.56%)
    69 / 6243 (1.11%)
         occurrences all number
    37
    38
    73
    Asthenia
         subjects affected / exposed
    36 / 12503 (0.29%)
    40 / 6226 (0.64%)
    55 / 6243 (0.88%)
         occurrences all number
    36
    41
    58
    Injection site warmth
         subjects affected / exposed
    5 / 12503 (0.04%)
    41 / 6226 (0.66%)
    78 / 6243 (1.25%)
         occurrences all number
    5
    43
    85
    Injection site pruritus
         subjects affected / exposed
    24 / 12503 (0.19%)
    41 / 6226 (0.66%)
    84 / 6243 (1.35%)
         occurrences all number
    24
    41
    90
    Administration site pain
         subjects affected / exposed
    8 / 12503 (0.06%)
    29 / 6226 (0.47%)
    54 / 6243 (0.86%)
         occurrences all number
    9
    30
    64
    Injection site rash
         subjects affected / exposed
    4 / 12503 (0.03%)
    10 / 6226 (0.16%)
    11 / 6243 (0.18%)
         occurrences all number
    4
    11
    11
    Injection site bruising
         subjects affected / exposed
    25 / 12503 (0.20%)
    17 / 6226 (0.27%)
    30 / 6243 (0.48%)
         occurrences all number
    25
    17
    30
    Chest pain
         subjects affected / exposed
    27 / 12503 (0.22%)
    25 / 6226 (0.40%)
    15 / 6243 (0.24%)
         occurrences all number
    28
    25
    15
    Feeling hot
         subjects affected / exposed
    12 / 12503 (0.10%)
    20 / 6226 (0.32%)
    33 / 6243 (0.53%)
         occurrences all number
    12
    20
    33
    Oedema peripheral
         subjects affected / exposed
    27 / 12503 (0.22%)
    12 / 6226 (0.19%)
    15 / 6243 (0.24%)
         occurrences all number
    27
    12
    15
    Influenza like illness
         subjects affected / exposed
    26 / 12503 (0.21%)
    11 / 6226 (0.18%)
    13 / 6243 (0.21%)
         occurrences all number
    26
    13
    13
    Injection site discomfort
         subjects affected / exposed
    4 / 12503 (0.03%)
    12 / 6226 (0.19%)
    24 / 6243 (0.38%)
         occurrences all number
    4
    12
    25
    Peripheral swelling
         subjects affected / exposed
    19 / 12503 (0.15%)
    11 / 6226 (0.18%)
    10 / 6243 (0.16%)
         occurrences all number
    19
    11
    10
    Injection site induration
         subjects affected / exposed
    4 / 12503 (0.03%)
    12 / 6226 (0.19%)
    23 / 6243 (0.37%)
         occurrences all number
    4
    12
    23
    Vaccination site erythema
         subjects affected / exposed
    2 / 12503 (0.02%)
    11 / 6226 (0.18%)
    23 / 6243 (0.37%)
         occurrences all number
    2
    11
    26
    Vaccination site swelling
         subjects affected / exposed
    0 / 12503 (0.00%)
    12 / 6226 (0.19%)
    24 / 6243 (0.38%)
         occurrences all number
    0
    12
    27
    Chest discomfort
         subjects affected / exposed
    13 / 12503 (0.10%)
    8 / 6226 (0.13%)
    10 / 6243 (0.16%)
         occurrences all number
    13
    8
    10
    Injection site oedema
         subjects affected / exposed
    1 / 12503 (0.01%)
    5 / 6226 (0.08%)
    22 / 6243 (0.35%)
         occurrences all number
    1
    5
    24
    Feeling cold
         subjects affected / exposed
    6 / 12503 (0.05%)
    9 / 6226 (0.14%)
    10 / 6243 (0.16%)
         occurrences all number
    7
    9
    11
    Injection site inflammation
         subjects affected / exposed
    4 / 12503 (0.03%)
    7 / 6226 (0.11%)
    14 / 6243 (0.22%)
         occurrences all number
    4
    7
    14
    Injection site reaction
         subjects affected / exposed
    13 / 12503 (0.10%)
    29 / 6226 (0.47%)
    39 / 6243 (0.62%)
         occurrences all number
    13
    30
    46
    Discomfort
         subjects affected / exposed
    5 / 12503 (0.04%)
    8 / 6226 (0.13%)
    11 / 6243 (0.18%)
         occurrences all number
    5
    8
    11
    Injection site haemorrhage
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    2
    3
    Administration site erythema
         subjects affected / exposed
    1 / 12503 (0.01%)
    6 / 6226 (0.10%)
    13 / 6243 (0.21%)
         occurrences all number
    1
    6
    14
    Swelling
         subjects affected / exposed
    5 / 12503 (0.04%)
    7 / 6226 (0.11%)
    7 / 6243 (0.11%)
         occurrences all number
    5
    7
    7
    Axillary pain
         subjects affected / exposed
    4 / 12503 (0.03%)
    4 / 6226 (0.06%)
    9 / 6243 (0.14%)
         occurrences all number
    4
    4
    9
    Cyst
         subjects affected / exposed
    7 / 12503 (0.06%)
    4 / 6226 (0.06%)
    5 / 6243 (0.08%)
         occurrences all number
    7
    6
    5
    Injection site movement impairment
         subjects affected / exposed
    1 / 12503 (0.01%)
    5 / 6226 (0.08%)
    9 / 6243 (0.14%)
         occurrences all number
    1
    5
    9
    Injection site mass
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    8 / 6243 (0.13%)
         occurrences all number
    3
    3
    9
    Administration site swelling
         subjects affected / exposed
    1 / 12503 (0.01%)
    4 / 6226 (0.06%)
    7 / 6243 (0.11%)
         occurrences all number
    1
    4
    7
    Vaccination site pruritus
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    7 / 6243 (0.11%)
         occurrences all number
    2
    3
    7
    Injection site hypoaesthesia
         subjects affected / exposed
    6 / 12503 (0.05%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences all number
    6
    2
    3
    Vaccination site reaction
         subjects affected / exposed
    2 / 12503 (0.02%)
    7 / 6226 (0.11%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    7
    2
    Adverse drug reaction
         subjects affected / exposed
    2 / 12503 (0.02%)
    4 / 6226 (0.06%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    4
    3
    Non-cardiac chest pain
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    2
    2
    Injection site hyperaesthesia
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences all number
    1
    2
    6
    Swelling face
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    1
    2
    Feeling abnormal
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    5 / 6243 (0.08%)
         occurrences all number
    1
    1
    5
    Injection site haematoma
         subjects affected / exposed
    10 / 12503 (0.08%)
    5 / 6226 (0.08%)
    7 / 6243 (0.11%)
         occurrences all number
    10
    5
    7
    Administration site joint pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    0
    0
    3
    Injection site urticaria
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    2
    1
    Vaccination site bruising
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    2
    2
    Hernia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    1
    1
    4
    Illness
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    2
    1
    Inflammation
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    1
    1
    4
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences all number
    0
    2
    4
    Injection site paraesthesia
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    2
    1
    Vaccination site warmth
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences all number
    0
    2
    4
    Administration site warmth
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    1
    1
    3
    Gait disturbance
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Injection site lymphadenopathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    3
    2
    Injection site nodule
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    3
    1
    Oedema
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    1
    1
    Temperature regulation disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    1
    1
    3
    Vessel puncture site bruise
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Ill-defined disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    4
    1
    Facial pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Feeling of body temperature change
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Granuloma
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Injection site irritation
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Mass
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Nodule
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Precancerous condition
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Puncture site erythema
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    1
    2
    Puncture site pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Secretion discharge
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Thirst
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Vaccination site inflammation
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    2
    1
    Vaccination site movement impairment
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    1
    2
    Administration site bruise
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Administration site pruritus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Calcinosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Complication associated with device
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Injection site extravasation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    0
    2
    Gravitational oedema
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Injection site discolouration
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Injection site joint discomfort
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Sensation of foreign body
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Vaccination site discolouration
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Vaccination site discomfort
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Vaccination site haematoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Vaccination site rash
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Vessel puncture site pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Administration site papule
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Application site pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Application site warmth
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Chronic fatigue syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Drug intolerance
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Face oedema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Fat necrosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Fat tissue increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Fibrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperthermia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Impaired healing
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Vessel puncture site reaction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site dermatitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site joint movement impairment
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site joint swelling
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site scab
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Local reaction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Localised oedema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Medical device pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Meteoropathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Pelvic mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Puncture site swelling
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    2
    Sluggishness
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Suprapubic pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site joint pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vaccination site joint swelling
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site paraesthesia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vessel puncture site haematoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Injection site coldness
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Withdrawal syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vessel puncture site swelling
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Amyloidosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Allergy to plants
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Anti-neutrophil cytoplasmic antibody positive vasculitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Mycotic allergy
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Rubber sensitivity
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Sarcoidosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Seasonal allergy
         subjects affected / exposed
    19 / 12503 (0.15%)
    16 / 6226 (0.26%)
    20 / 6243 (0.32%)
         occurrences all number
    19
    16
    21
    Drug hypersensitivity
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    6 / 6243 (0.10%)
         occurrences all number
    3
    3
    6
    Hypersensitivity
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences all number
    5
    2
    3
    Multiple allergies
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    1
    3
    Food allergy
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Allergy to arthropod sting
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Allergy to chemicals
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Allergy to vaccine
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Dust allergy
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Social circumstances
    Menopause
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Ex-tobacco user
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Immobile
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    2
    1
    Cystocele
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Benign prostatic hyperplasia
         subjects affected / exposed
    33 / 12503 (0.26%)
    8 / 6226 (0.13%)
    21 / 6243 (0.34%)
         occurrences all number
    33
    8
    21
    Prostatomegaly
         subjects affected / exposed
    7 / 12503 (0.06%)
    1 / 6226 (0.02%)
    6 / 6243 (0.10%)
         occurrences all number
    7
    1
    6
    Prostatitis
         subjects affected / exposed
    5 / 12503 (0.04%)
    4 / 6226 (0.06%)
    0 / 6243 (0.00%)
         occurrences all number
    5
    4
    0
    Breast mass
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    3
    1
    Breast pain
         subjects affected / exposed
    2 / 12503 (0.02%)
    5 / 6226 (0.08%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    5
    1
    Ovarian cyst
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    5
    0
    1
    Erectile dysfunction
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    3
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Uterine prolapse
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    2
    0
    Vaginal haemorrhage
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    1
    0
    Atrophic vulvovaginitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Rectocele
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Testicular pain
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Testicular swelling
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Uterine polyp
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Balanoposthitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Bartholin's cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Breast discomfort
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    2
    Coital bleeding
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Endometrial thickening
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Epididymal cyst
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Female genital tract fistula
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Genital haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Genital rash
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Macroorchidism
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Menopausal symptoms
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Nipple pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Perineal rash
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatic disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatic pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatic mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Scrotal swelling
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal discomfort
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Vaginal discharge
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Sinus congestion
         subjects affected / exposed
    10 / 12503 (0.08%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences all number
    10
    4
    4
    Cough
         subjects affected / exposed
    229 / 12503 (1.83%)
    128 / 6226 (2.06%)
    135 / 6243 (2.16%)
         occurrences all number
    241
    139
    143
    Rhinorrhoea
         subjects affected / exposed
    202 / 12503 (1.62%)
    141 / 6226 (2.26%)
    127 / 6243 (2.03%)
         occurrences all number
    225
    156
    133
    Oropharyngeal pain
         subjects affected / exposed
    194 / 12503 (1.55%)
    121 / 6226 (1.94%)
    88 / 6243 (1.41%)
         occurrences all number
    208
    127
    101
    Nasal congestion
         subjects affected / exposed
    98 / 12503 (0.78%)
    51 / 6226 (0.82%)
    51 / 6243 (0.82%)
         occurrences all number
    108
    53
    53
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    71 / 12503 (0.57%)
    33 / 6226 (0.53%)
    37 / 6243 (0.59%)
         occurrences all number
    90
    38
    44
    Asthma
         subjects affected / exposed
    54 / 12503 (0.43%)
    31 / 6226 (0.50%)
    23 / 6243 (0.37%)
         occurrences all number
    62
    41
    27
    Dyspnoea
         subjects affected / exposed
    53 / 12503 (0.42%)
    23 / 6226 (0.37%)
    29 / 6243 (0.46%)
         occurrences all number
    56
    23
    31
    Sneezing
         subjects affected / exposed
    42 / 12503 (0.34%)
    30 / 6226 (0.48%)
    27 / 6243 (0.43%)
         occurrences all number
    44
    30
    27
    Productive cough
         subjects affected / exposed
    42 / 12503 (0.34%)
    14 / 6226 (0.22%)
    30 / 6243 (0.48%)
         occurrences all number
    42
    15
    30
    Respiratory disorder
         subjects affected / exposed
    44 / 12503 (0.35%)
    25 / 6226 (0.40%)
    17 / 6243 (0.27%)
         occurrences all number
    46
    25
    18
    Throat irritation
         subjects affected / exposed
    29 / 12503 (0.23%)
    5 / 6226 (0.08%)
    13 / 6243 (0.21%)
         occurrences all number
    31
    5
    13
    Epistaxis
         subjects affected / exposed
    18 / 12503 (0.14%)
    11 / 6226 (0.18%)
    16 / 6243 (0.26%)
         occurrences all number
    18
    12
    17
    Rhinitis allergic
         subjects affected / exposed
    15 / 12503 (0.12%)
    8 / 6226 (0.13%)
    10 / 6243 (0.16%)
         occurrences all number
    16
    8
    10
    Dysphonia
         subjects affected / exposed
    11 / 12503 (0.09%)
    15 / 6226 (0.24%)
    6 / 6243 (0.10%)
         occurrences all number
    11
    15
    6
    Pulmonary mass
         subjects affected / exposed
    15 / 12503 (0.12%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences all number
    16
    4
    4
    Wheezing
         subjects affected / exposed
    10 / 12503 (0.08%)
    6 / 6226 (0.10%)
    4 / 6243 (0.06%)
         occurrences all number
    11
    6
    4
    Interstitial lung disease
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    2
    1
    4
    Bronchial hyperreactivity
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    0
    0
    Lower respiratory tract congestion
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    1
    2
    Pulmonary embolism
         subjects affected / exposed
    1 / 12503 (0.01%)
    4 / 6226 (0.06%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    4
    1
    Sinus pain
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    4 / 6243 (0.06%)
         occurrences all number
    2
    0
    4
    Upper respiratory tract inflammation
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    6
    2
    0
    Aphonia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    0
    3
    Oropharyngeal discomfort
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    1
    1
    Pleural effusion
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    1
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    10 / 12503 (0.08%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences all number
    10
    4
    4
    Dry throat
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    5 / 6243 (0.08%)
         occurrences all number
    5
    3
    6
    Increased upper airway secretion
         subjects affected / exposed
    6 / 12503 (0.05%)
    4 / 6226 (0.06%)
    3 / 6243 (0.05%)
         occurrences all number
    6
    4
    3
    Dyspnoea exertional
         subjects affected / exposed
    3 / 12503 (0.02%)
    6 / 6226 (0.10%)
    3 / 6243 (0.05%)
         occurrences all number
    3
    6
    3
    Paranasal sinus discomfort
         subjects affected / exposed
    4 / 12503 (0.03%)
    7 / 6226 (0.11%)
    0 / 6243 (0.00%)
         occurrences all number
    7
    8
    0
    Bronchitis chronic
         subjects affected / exposed
    2 / 12503 (0.02%)
    5 / 6226 (0.08%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    5
    2
    Emphysema
         subjects affected / exposed
    1 / 12503 (0.01%)
    5 / 6226 (0.08%)
    3 / 6243 (0.05%)
         occurrences all number
    1
    5
    3
    Sputum increased
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences all number
    2
    2
    5
    Upper-airway cough syndrome
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    3
    2
    Bronchiectasis
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    3
    1
    Haemoptysis
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    3
    2
    Pulmonary congestion
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    3
    0
    Pulmonary fibrosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Respiratory tract congestion
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    2
    0
    Hypoxia
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    5
    1
    0
    Catarrh
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    0
    2
    Pulmonary pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Nasal discomfort
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    0
    2
    Nasal obstruction
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    0
    2
    Nasal polyps
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    1
    0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Painful respiration
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    3
    1
    Paranasal sinus hypersecretion
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Pneumonitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Rales
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    1
    0
    3
    Increased bronchial secretion
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Lung disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Nasal pruritus
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    1
    2
    Pharyngeal swelling
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Pleurisy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    0
    2
    Pleuritic pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Pulmonary hypertension
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Reflux laryngitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    3
    0
    Bronchospasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Lung consolidation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Orthopnoea
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Pulmonary oedema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Hiccups
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Pulmonary thrombosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Nasal dryness
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinalgia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Acute respiratory failure
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Allergic cough
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Allergic sinusitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Aspiration
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Asthma exercise induced
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Asthma-chronic obstructive pulmonary disease overlap syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Atelectasis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Bronchial wall thickening
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Choking sensation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Cystic lung disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Epiglottic cyst
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperventilation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngeal oedema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngospasm
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Lung hyperinflation
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Lung opacity
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal cavity mass
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Nasal crusting
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Nasal cyst
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory symptom
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Pneumothorax
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pleural thickening
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Sinonasal obstruction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Sputum discoloured
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Sputum retention
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Suffocation feeling
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Throat clearing
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Throat lesion
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillar cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Tracheal inflammation
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Nasal septum deviation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal ulcer
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Neurogenic cough
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Nocturnal dyspnoea
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Obstructive airways disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Paranasal sinus inflammation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngeal inflammation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngeal paraesthesia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngeal ulceration
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pleural fibrosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Rhonchi
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Upper airway obstruction
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Vasomotor rhinitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vocal cord polyp
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    3
    1
    Panic attack
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Alcoholism
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Depressed mood
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    1
    2
    Nightmare
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Persistent depressive disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Agitation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Anxiety disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Apathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Middle insomnia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Mood swings
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Obsessive-compulsive disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Poor quality sleep
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Adjustment disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Affective disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Depression
         subjects affected / exposed
    52 / 12503 (0.42%)
    18 / 6226 (0.29%)
    20 / 6243 (0.32%)
         occurrences all number
    52
    18
    20
    Insomnia
         subjects affected / exposed
    37 / 12503 (0.30%)
    21 / 6226 (0.34%)
    23 / 6243 (0.37%)
         occurrences all number
    37
    21
    24
    Anxiety
         subjects affected / exposed
    19 / 12503 (0.15%)
    25 / 6226 (0.40%)
    23 / 6243 (0.37%)
         occurrences all number
    19
    25
    25
    Sleep disorder
         subjects affected / exposed
    4 / 12503 (0.03%)
    4 / 6226 (0.06%)
    5 / 6243 (0.08%)
         occurrences all number
    4
    4
    5
    Stress
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    1
    2
    Confusional state
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    3
    1
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    0
    2
    Restlessness
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    2
    2
    Abnormal dreams
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    3
    1
    Agoraphobia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Sleep terror
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Anhedonia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Binge eating
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bipolar disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Disorientation
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Emotional disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Generalised anxiety disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Grief reaction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Habit cough
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hallucination
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Libido decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Major depression
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Mental status changes
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Mood altered
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Nervousness
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Neurosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Panic disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Psychotic disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Schizophrenia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Anger
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Somnambulism
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Terminal insomnia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Suicidal ideation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Product issues
    Device breakage
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Device dislocation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Gallbladder disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cholelithiasis
         subjects affected / exposed
    12 / 12503 (0.10%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    12
    1
    4
    Hepatic steatosis
         subjects affected / exposed
    6 / 12503 (0.05%)
    3 / 6226 (0.05%)
    6 / 6243 (0.10%)
         occurrences all number
    6
    3
    6
    Cholecystitis
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Hepatic mass
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Hepatic cirrhosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Non-alcoholic fatty liver
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Autoimmune hepatitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bile duct stone
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cholangitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Gallbladder polyp
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Hepatomegaly
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Liver disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood potassium increased
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    2
    1
    Body temperature increased
         subjects affected / exposed
    5 / 12503 (0.04%)
    15 / 6226 (0.24%)
    39 / 6243 (0.62%)
         occurrences all number
    6
    15
    42
    Blood pressure increased
         subjects affected / exposed
    31 / 12503 (0.25%)
    13 / 6226 (0.21%)
    10 / 6243 (0.16%)
         occurrences all number
    31
    13
    10
    SARS-CoV-2 test positive
         subjects affected / exposed
    17 / 12503 (0.14%)
    9 / 6226 (0.14%)
    11 / 6243 (0.18%)
         occurrences all number
    17
    9
    12
    Weight decreased
         subjects affected / exposed
    9 / 12503 (0.07%)
    9 / 6226 (0.14%)
    4 / 6243 (0.06%)
         occurrences all number
    9
    9
    4
    Blood cholesterol increased
         subjects affected / exposed
    8 / 12503 (0.06%)
    4 / 6226 (0.06%)
    8 / 6243 (0.13%)
         occurrences all number
    8
    4
    8
    Cardiac murmur
         subjects affected / exposed
    6 / 12503 (0.05%)
    7 / 6226 (0.11%)
    5 / 6243 (0.08%)
         occurrences all number
    6
    7
    5
    Prostatic specific antigen increased
         subjects affected / exposed
    7 / 12503 (0.06%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences all number
    7
    3
    3
    Heart rate increased
         subjects affected / exposed
    5 / 12503 (0.04%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    4
    2
    Heart rate irregular
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    5
    2
    1
    Blood glucose increased
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    3
    1
    Weight increased
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    3
    0
    3
    Blood creatinine increased
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    5
    0
    0
    Platelet count decreased
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    SARS-CoV-2 antibody test positive
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Serum ferritin decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Urine output increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Vitamin B12 decreased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Allergy test positive
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Glycosylated haemoglobin increased
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    2
    1
    Haemoglobin decreased
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    3
    0
    Blood pressure decreased
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Blood urine present
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Blood testosterone decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    3
    0
    Blood uric acid increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Chest X-ray abnormal
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Intraocular pressure increased
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Blood glucose decreased
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Blood pressure abnormal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Blood sodium decreased
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Bone density decreased
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Helicobacter test positive
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Liver function test increased
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Occult blood positive
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Rheumatoid factor increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Amylase increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Colonoscopy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Biopsy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Biopsy breast
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Blood glucose abnormal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Blood immunoglobulin E increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Blood immunoglobulin G decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Blood iron increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Blood pressure diastolic increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Blood test abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Body temperature decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Brain natriuretic peptide increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Breast scan abnormal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Breath sounds abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Carcinoembryonic antigen increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Antinuclear antibody positive
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Computerised tomogram thorax abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Electroencephalogram abnormal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    HIV test positive
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Haemoglobin increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatitis B surface antibody positive
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza B virus test positive
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Investigation abnormal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Lipids abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Occult blood
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Pulse abnormal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory rate increased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Sputum abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Total lung capacity decreased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cystoscopy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    29 / 12503 (0.23%)
    16 / 6226 (0.26%)
    10 / 6243 (0.16%)
         occurrences all number
    30
    16
    10
    Fall
         subjects affected / exposed
    54 / 12503 (0.43%)
    28 / 6226 (0.45%)
    30 / 6243 (0.48%)
         occurrences all number
    55
    28
    30
    Contusion
         subjects affected / exposed
    45 / 12503 (0.36%)
    22 / 6226 (0.35%)
    14 / 6243 (0.22%)
         occurrences all number
    46
    23
    14
    Arthropod bite
         subjects affected / exposed
    23 / 12503 (0.18%)
    16 / 6226 (0.26%)
    21 / 6243 (0.34%)
         occurrences all number
    24
    16
    22
    Ligament sprain
         subjects affected / exposed
    25 / 12503 (0.20%)
    15 / 6226 (0.24%)
    9 / 6243 (0.14%)
         occurrences all number
    25
    16
    9
    Craniofacial fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    7 / 6243 (0.11%)
         occurrences all number
    2
    2
    7
    Muscle strain
         subjects affected / exposed
    24 / 12503 (0.19%)
    10 / 6226 (0.16%)
    11 / 6243 (0.18%)
         occurrences all number
    25
    10
    11
    Procedural pain
         subjects affected / exposed
    21 / 12503 (0.17%)
    12 / 6226 (0.19%)
    7 / 6243 (0.11%)
         occurrences all number
    22
    12
    7
    Tooth fracture
         subjects affected / exposed
    21 / 12503 (0.17%)
    5 / 6226 (0.08%)
    9 / 6243 (0.14%)
         occurrences all number
    21
    5
    9
    Foot fracture
         subjects affected / exposed
    16 / 12503 (0.13%)
    9 / 6226 (0.14%)
    5 / 6243 (0.08%)
         occurrences all number
    16
    9
    5
    Immunisation reaction
         subjects affected / exposed
    13 / 12503 (0.10%)
    4 / 6226 (0.06%)
    9 / 6243 (0.14%)
         occurrences all number
    14
    4
    9
    Rib fracture
         subjects affected / exposed
    16 / 12503 (0.13%)
    5 / 6226 (0.08%)
    5 / 6243 (0.08%)
         occurrences all number
    16
    5
    6
    Arthropod sting
         subjects affected / exposed
    13 / 12503 (0.10%)
    4 / 6226 (0.06%)
    6 / 6243 (0.10%)
         occurrences all number
    15
    4
    6
    Joint injury
         subjects affected / exposed
    16 / 12503 (0.13%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences all number
    16
    3
    3
    Head injury
         subjects affected / exposed
    9 / 12503 (0.07%)
    5 / 6226 (0.08%)
    7 / 6243 (0.11%)
         occurrences all number
    9
    5
    7
    Wrist fracture
         subjects affected / exposed
    8 / 12503 (0.06%)
    5 / 6226 (0.08%)
    8 / 6243 (0.13%)
         occurrences all number
    8
    5
    8
    Animal bite
         subjects affected / exposed
    9 / 12503 (0.07%)
    6 / 6226 (0.10%)
    3 / 6243 (0.05%)
         occurrences all number
    9
    6
    3
    Meniscus injury
         subjects affected / exposed
    9 / 12503 (0.07%)
    5 / 6226 (0.08%)
    4 / 6243 (0.06%)
         occurrences all number
    9
    5
    4
    Soft tissue injury
         subjects affected / exposed
    10 / 12503 (0.08%)
    5 / 6226 (0.08%)
    3 / 6243 (0.05%)
         occurrences all number
    10
    5
    3
    Hand fracture
         subjects affected / exposed
    10 / 12503 (0.08%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences all number
    10
    2
    4
    Radius fracture
         subjects affected / exposed
    6 / 12503 (0.05%)
    7 / 6226 (0.11%)
    2 / 6243 (0.03%)
         occurrences all number
    6
    7
    2
    Skin abrasion
         subjects affected / exposed
    9 / 12503 (0.07%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences all number
    10
    3
    3
    Tendon rupture
         subjects affected / exposed
    7 / 12503 (0.06%)
    5 / 6226 (0.08%)
    3 / 6243 (0.05%)
         occurrences all number
    7
    5
    4
    Ligament rupture
         subjects affected / exposed
    5 / 12503 (0.04%)
    5 / 6226 (0.08%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    5
    2
    Thermal burn
         subjects affected / exposed
    8 / 12503 (0.06%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    8
    1
    3
    Clavicle fracture
         subjects affected / exposed
    8 / 12503 (0.06%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    8
    0
    3
    Limb injury
         subjects affected / exposed
    17 / 12503 (0.14%)
    17 / 6226 (0.27%)
    11 / 6243 (0.18%)
         occurrences all number
    17
    18
    11
    Ankle fracture
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences all number
    4
    3
    3
    Bone contusion
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences all number
    4
    2
    4
    Fibula fracture
         subjects affected / exposed
    4 / 12503 (0.03%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    4
    2
    Concussion
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    4 / 6243 (0.06%)
         occurrences all number
    2
    3
    4
    Lower limb fracture
         subjects affected / exposed
    7 / 12503 (0.06%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    7
    1
    1
    Muscle rupture
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    2
    2
    Road traffic accident
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences all number
    3
    2
    4
    Eye injury
         subjects affected / exposed
    6 / 12503 (0.05%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    6
    1
    1
    Humerus fracture
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    3
    1
    Joint dislocation
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    6
    2
    1
    Upper limb fracture
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    5
    2
    1
    Patella fracture
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    4
    0
    3
    Chest injury
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    2
    2
    Epicondylitis
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    1
    1
    Spinal compression fracture
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    3
    0
    3
    Tibia fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    5 / 6226 (0.08%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    5
    0
    Eye contusion
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    2
    1
    Face injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    2
    2
    Post-traumatic neck syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    2
    2
    Back injury
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Burns second degree
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    1
    0
    Corneal abrasion
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Exposure to SARS-CoV-2
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Stress fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    1
    2
    Wound
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    0
    2
    Femur fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Radiation injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Post procedural contusion
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Post procedural complication
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Pelvic fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Muscle contusion
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Multiple injuries
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Lip injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Ligament injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Jaw fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Injury
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Hypobarism
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Heat illness
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Fractured coccyx
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Foreign body in throat
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Foreign body in eye
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Forearm fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Ulna fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Tendon injury
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Synovial rupture
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Musculoskeletal foreign body
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Muscle injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Scapula fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Foreign body in respiratory tract
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Foreign body in ear
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Extradural haematoma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Exposure to toxic agent
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Electric shock
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Dental restoration failure
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Craniocerebral injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Corneal epithelial downgrowth
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Chillblains
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Chemical burns of eye
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Burn oral cavity
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Bone fragmentation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bite
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Avulsion fracture
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Accidental overdose
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Wound complication
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Tooth injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Sunburn
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Sternal fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Spinal fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Spinal column injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Metal poisoning
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Mouth injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Multiple fractures
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Neck injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Nerve injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Open fracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Overdose
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Penis injury
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Periprocedural myocardial infarction
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Post procedural haematuria
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Post-traumatic pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural dizziness
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Procedural nausea
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Procedural vomiting
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary contusion
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Radiation pneumonitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Renal transplant failure
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Scar
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Seroma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hyphaema
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Iliotibial band syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    2
    Injection related reaction
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Skeletal injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Skin wound
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Venomous sting
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Sports injury
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Snake bite
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Skull fractured base
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Skull fracture
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Type V hyperlipidaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Arteriovenous malformation
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Epidermal naevus
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Frenulum breve
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Gilbert's syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hydrocele
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Porokeratosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pyloric stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth hypoplasia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Turner's syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    90 / 12503 (0.72%)
    35 / 6226 (0.56%)
    32 / 6243 (0.51%)
         occurrences all number
    96
    36
    33
    Palpitations
         subjects affected / exposed
    20 / 12503 (0.16%)
    10 / 6226 (0.16%)
    5 / 6243 (0.08%)
         occurrences all number
    22
    11
    5
    Angina pectoris
         subjects affected / exposed
    11 / 12503 (0.09%)
    5 / 6226 (0.08%)
    10 / 6243 (0.16%)
         occurrences all number
    11
    6
    12
    Myocardial infarction
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Bradycardia
         subjects affected / exposed
    10 / 12503 (0.08%)
    4 / 6226 (0.06%)
    8 / 6243 (0.13%)
         occurrences all number
    10
    4
    8
    Coronary artery disease
         subjects affected / exposed
    6 / 12503 (0.05%)
    6 / 6226 (0.10%)
    7 / 6243 (0.11%)
         occurrences all number
    6
    6
    7
    Cardiac failure congestive
         subjects affected / exposed
    7 / 12503 (0.06%)
    6 / 6226 (0.10%)
    5 / 6243 (0.08%)
         occurrences all number
    7
    6
    5
    Arrhythmia
         subjects affected / exposed
    9 / 12503 (0.07%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences all number
    9
    4
    4
    Cardiac failure
         subjects affected / exposed
    9 / 12503 (0.07%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences all number
    9
    2
    5
    Myocardial ischaemia
         subjects affected / exposed
    6 / 12503 (0.05%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences all number
    6
    3
    3
    Extrasystoles
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    7
    2
    0
    Atrial flutter
         subjects affected / exposed
    2 / 12503 (0.02%)
    5 / 6226 (0.08%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    5
    0
    Mitral valve incompetence
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    3
    1
    Ventricular extrasystoles
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    5
    0
    1
    Ventricular tachycardia
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    1
    2
    Cardiac failure chronic
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    1
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    2
    0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    2
    2
    Acute myocardial infarction
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Angina unstable
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Bundle branch block right
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    2
    1
    Cardiomegaly
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Cardiovascular disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    3
    0
    Tachycardia
         subjects affected / exposed
    12 / 12503 (0.10%)
    9 / 6226 (0.14%)
    3 / 6243 (0.05%)
         occurrences all number
    12
    9
    3
    Sinus bradycardia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Cardiac ventricular thrombosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Atrial tachycardia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Atrioventricular block
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Cardiomyopathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Chronic coronary syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Heart failure with reduced ejection fraction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Heart valve incompetence
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Mitral valve calcification
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Mitral valve prolapse
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Mitral valve stenosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    3
    0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Aortic valve calcification
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Bundle branch block
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bundle branch block left
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Cardiac disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac valve disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Tachycardia paroxysmal
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Dilated cardiomyopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Diastolic dysfunction
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Myocarditis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Myopericarditis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pericarditis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Prinzmetal angina
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Right ventricular hypertrophy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Sinoatrial block
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Wolff-Parkinson-White syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    710 / 12503 (5.68%)
    594 / 6226 (9.54%)
    664 / 6243 (10.64%)
         occurrences all number
    856
    712
    820
    Neuralgia
         subjects affected / exposed
    6 / 12503 (0.05%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences all number
    7
    2
    3
    Sciatica
         subjects affected / exposed
    43 / 12503 (0.34%)
    18 / 6226 (0.29%)
    21 / 6243 (0.34%)
         occurrences all number
    44
    18
    21
    Lethargy
         subjects affected / exposed
    14 / 12503 (0.11%)
    19 / 6226 (0.31%)
    13 / 6243 (0.21%)
         occurrences all number
    14
    21
    13
    Syncope
         subjects affected / exposed
    20 / 12503 (0.16%)
    9 / 6226 (0.14%)
    12 / 6243 (0.19%)
         occurrences all number
    21
    9
    12
    Paraesthesia
         subjects affected / exposed
    17 / 12503 (0.14%)
    13 / 6226 (0.21%)
    9 / 6243 (0.14%)
         occurrences all number
    17
    13
    9
    Migraine
         subjects affected / exposed
    20 / 12503 (0.16%)
    6 / 6226 (0.10%)
    9 / 6243 (0.14%)
         occurrences all number
    25
    6
    12
    Hypoaesthesia
         subjects affected / exposed
    12 / 12503 (0.10%)
    14 / 6226 (0.22%)
    8 / 6243 (0.13%)
         occurrences all number
    12
    15
    8
    Carpal tunnel syndrome
         subjects affected / exposed
    19 / 12503 (0.15%)
    6 / 6226 (0.10%)
    7 / 6243 (0.11%)
         occurrences all number
    20
    6
    7
    Neuropathy peripheral
         subjects affected / exposed
    16 / 12503 (0.13%)
    8 / 6226 (0.13%)
    7 / 6243 (0.11%)
         occurrences all number
    16
    8
    7
    Somnolence
         subjects affected / exposed
    10 / 12503 (0.08%)
    10 / 6226 (0.16%)
    11 / 6243 (0.18%)
         occurrences all number
    10
    10
    11
    Tremor
         subjects affected / exposed
    11 / 12503 (0.09%)
    5 / 6226 (0.08%)
    6 / 6243 (0.10%)
         occurrences all number
    11
    5
    6
    Cognitive disorder
         subjects affected / exposed
    10 / 12503 (0.08%)
    5 / 6226 (0.08%)
    4 / 6243 (0.06%)
         occurrences all number
    10
    5
    4
    Dementia
         subjects affected / exposed
    9 / 12503 (0.07%)
    5 / 6226 (0.08%)
    4 / 6243 (0.06%)
         occurrences all number
    9
    5
    4
    Sinus headache
         subjects affected / exposed
    9 / 12503 (0.07%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences all number
    9
    2
    5
    Amnesia
         subjects affected / exposed
    7 / 12503 (0.06%)
    3 / 6226 (0.05%)
    4 / 6243 (0.06%)
         occurrences all number
    7
    3
    4
    Nerve compression
         subjects affected / exposed
    5 / 12503 (0.04%)
    5 / 6226 (0.08%)
    4 / 6243 (0.06%)
         occurrences all number
    5
    5
    4
    Dysgeusia
         subjects affected / exposed
    6 / 12503 (0.05%)
    4 / 6226 (0.06%)
    3 / 6243 (0.05%)
         occurrences all number
    6
    4
    3
    Tension headache
         subjects affected / exposed
    8 / 12503 (0.06%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences all number
    10
    2
    3
    Diabetic neuropathy
         subjects affected / exposed
    7 / 12503 (0.06%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    7
    1
    3
    Dizziness
         subjects affected / exposed
    105 / 12503 (0.84%)
    66 / 6226 (1.06%)
    88 / 6243 (1.41%)
         occurrences all number
    112
    73
    91
    Balance disorder
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    5 / 6243 (0.08%)
         occurrences all number
    4
    1
    5
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    3
    1
    Restless legs syndrome
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    3
    2
    Dementia Alzheimer's type
         subjects affected / exposed
    3 / 12503 (0.02%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    4
    2
    Bell's palsy
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    3
    2
    Parkinson's disease
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    2
    2
    Transient ischaemic attack
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    2
    2
    Memory impairment
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    1
    2
    Brain fog
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    1
    3
    Head discomfort
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    2
    2
    Radiculopathy
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    1
    3
    Ageusia
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    0
    2
    Burning sensation
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Cervical radiculopathy
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    2
    1
    Loss of consciousness
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    1
    1
    Presyncope
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    3
    2
    Hydrocephalus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Dizziness postural
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    2
    1
    Disturbance in attention
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    1
    0
    Dysarthria
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    0
    2
    Intercostal neuralgia
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    2
    0
    Intracranial aneurysm
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Ophthalmic migraine
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    4
    1
    Polyneuropathy
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Post-traumatic headache
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    0
    0
    Trigeminal neuralgia
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    0
    0
    Anosmia
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Carotid arteriosclerosis
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    2
    1
    Cluster headache
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Essential tremor
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Hypersomnia
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Myasthenia gravis
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    3
    0
    Parkinsonism
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Peroneal nerve palsy
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Cerebrovascular accident
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    2
    1
    Nervous system disorder
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Drooling
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Petit mal epilepsy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Resting tremor
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Seizure
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Tardive dyskinesia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Amnestic disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Apraxia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Axonal and demyelinating polyneuropathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Axonal neuropathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Brain hypoxia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Cerebellar atrophy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cerebral amyloid angiopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cerebral infarction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Coordination abnormal
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Crocodile tears syndrome
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Dementia of the Alzheimer's type, uncomplicated
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Dural arteriovenous fistula
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Sensory loss
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Epilepsy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Facial spasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Formication
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Hemiparesis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Hyposmia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Hypotonia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    IVth nerve paralysis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Ischaemic stroke
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Mental impairment
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Micrographia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Monoparesis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Motor dysfunction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Movement disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Myoclonus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Occipital neuralgia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Parosmia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral nerve paresis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Sensory disturbance
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Dyskinesia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Sleep deficit
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Spasmodic dysphonia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Spinal claudication
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Taste disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Thunderclap headache
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Toxic neuropathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Transient global amnesia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Vestibular migraine
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Macrocytosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Anaemia
         subjects affected / exposed
    24 / 12503 (0.19%)
    14 / 6226 (0.22%)
    10 / 6243 (0.16%)
         occurrences all number
    24
    14
    10
    Lymphadenopathy
         subjects affected / exposed
    10 / 12503 (0.08%)
    11 / 6226 (0.18%)
    13 / 6243 (0.21%)
         occurrences all number
    11
    11
    15
    Iron deficiency anaemia
         subjects affected / exposed
    18 / 12503 (0.14%)
    4 / 6226 (0.06%)
    6 / 6243 (0.10%)
         occurrences all number
    18
    4
    6
    Lymph node pain
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    2
    2
    Thrombocytopenia
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    1
    1
    Thrombocytosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    3
    0
    Leukocytosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Leukopenia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Immune thrombocytopenia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Lymphadenitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Pernicious anaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Anaemia folate deficiency
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Anaemia macrocytic
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Antiphospholipid syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bone marrow oedema
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Coagulopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Increased tendency to bruise
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Normocytic anaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pancytopenia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Polycythaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Spleen disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    White blood cell disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Motion sickness
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Vertigo
         subjects affected / exposed
    47 / 12503 (0.38%)
    26 / 6226 (0.42%)
    20 / 6243 (0.32%)
         occurrences all number
    52
    26
    20
    Ear pain
         subjects affected / exposed
    30 / 12503 (0.24%)
    13 / 6226 (0.21%)
    16 / 6243 (0.26%)
         occurrences all number
    31
    13
    17
    Tinnitus
         subjects affected / exposed
    20 / 12503 (0.16%)
    7 / 6226 (0.11%)
    9 / 6243 (0.14%)
         occurrences all number
    21
    8
    9
    Vertigo positional
         subjects affected / exposed
    7 / 12503 (0.06%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    8
    1
    3
    Cerumen impaction
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    7
    2
    1
    Ear discomfort
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    5 / 6243 (0.08%)
         occurrences all number
    5
    0
    5
    Hypoacusis
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    5
    1
    3
    Deafness
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    1
    1
    Deafness bilateral
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    3
    0
    Deafness unilateral
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Eustachian tube dysfunction
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Meniere's disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    3
    1
    Deafness neurosensory
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Tympanic membrane perforation
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Ear congestion
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Ear inflammation
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Inner ear disorder
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Middle ear effusion
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Ear haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Ear disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Eustachian tube obstruction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Inner ear inflammation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Sudden hearing loss
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Vestibular disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Otorrhoea
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Otosclerosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Tympanic membrane disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Deafness transitory
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Ear pruritus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    56 / 12503 (0.45%)
    19 / 6226 (0.31%)
    22 / 6243 (0.35%)
         occurrences all number
    63
    20
    23
    Eye pain
         subjects affected / exposed
    11 / 12503 (0.09%)
    8 / 6226 (0.13%)
    9 / 6243 (0.14%)
         occurrences all number
    11
    8
    9
    Glaucoma
         subjects affected / exposed
    17 / 12503 (0.14%)
    3 / 6226 (0.05%)
    8 / 6243 (0.13%)
         occurrences all number
    17
    3
    10
    Dry eye
         subjects affected / exposed
    14 / 12503 (0.11%)
    4 / 6226 (0.06%)
    7 / 6243 (0.11%)
         occurrences all number
    14
    4
    7
    Lacrimation increased
         subjects affected / exposed
    13 / 12503 (0.10%)
    6 / 6226 (0.10%)
    6 / 6243 (0.10%)
         occurrences all number
    15
    6
    6
    Macular degeneration
         subjects affected / exposed
    6 / 12503 (0.05%)
    10 / 6226 (0.16%)
    5 / 6243 (0.08%)
         occurrences all number
    6
    10
    5
    Eye pruritus
         subjects affected / exposed
    10 / 12503 (0.08%)
    4 / 6226 (0.06%)
    1 / 6243 (0.02%)
         occurrences all number
    10
    4
    1
    Blepharitis
         subjects affected / exposed
    4 / 12503 (0.03%)
    6 / 6226 (0.10%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    7
    2
    Vision blurred
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    3
    2
    Retinal detachment
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    3
    1
    Vitreous detachment
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    2
    2
    Entropion
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Ocular hyperaemia
         subjects affected / exposed
    6 / 12503 (0.05%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    6
    0
    0
    Retinal tear
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    2
    1
    Visual impairment
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    1
    1
    4
    Conjunctivitis allergic
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    0
    1
    Eye discharge
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Eye irritation
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    1
    1
    Diplopia
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    5
    0
    0
    Epiretinal membrane
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Eye disorder
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Eye swelling
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Vitreous floaters
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Asthenopia
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Diabetic retinopathy
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Eyelid ptosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Macular hole
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    2
    1
    Neovascular age-related macular degeneration
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Posterior capsule opacification
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    3
    0
    Retinal artery occlusion
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Swelling of eyelid
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    0
    2
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    1
    2
    Erythema of eyelid
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema eyelids
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Eye haematoma
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Eye allergy
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    3
    0
    Eye haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Eyelid cyst
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Eyelid pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Keratitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Photophobia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Photopsia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Ulcerative keratitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Uveitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Abnormal sensation in eye
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Blepharospasm
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Blindness
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Cataract nuclear
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Choroidal neovascularisation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatochalasis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Dry age-related macular degeneration
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Eye degenerative disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Eye inflammation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal neovascularisation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid margin crusting
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid skin dryness
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Eyelids pruritus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Iridocyclitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Lacrimal fistula
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Macular scar
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Maculopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Meibomian gland dysfunction
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Metamorphopsia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Narrow anterior chamber angle
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Ocular discomfort
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Ocular hypertension
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Optic nerve sheath haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Periorbital oedema
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Periorbital swelling
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pinguecula
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pterygium
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal degeneration
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal infarction
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Eye ulcer
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Retinal oedema
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Retinopathy hypertensive
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Scleral hyperaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Scleritis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Trichiasis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Visual field defect
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Vitreous opacities
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal vascular thrombosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences all number
    7
    2
    5
    Diarrhoea
         subjects affected / exposed
    217 / 12503 (1.74%)
    119 / 6226 (1.91%)
    107 / 6243 (1.71%)
         occurrences all number
    230
    129
    110
    Nausea
         subjects affected / exposed
    70 / 12503 (0.56%)
    70 / 6226 (1.12%)
    76 / 6243 (1.22%)
         occurrences all number
    72
    73
    79
    Vomiting
         subjects affected / exposed
    51 / 12503 (0.41%)
    28 / 6226 (0.45%)
    27 / 6243 (0.43%)
         occurrences all number
    53
    30
    27
    Abdominal pain upper
         subjects affected / exposed
    47 / 12503 (0.38%)
    23 / 6226 (0.37%)
    29 / 6243 (0.46%)
         occurrences all number
    51
    23
    30
    Gastrooesophageal reflux disease
         subjects affected / exposed
    51 / 12503 (0.41%)
    13 / 6226 (0.21%)
    31 / 6243 (0.50%)
         occurrences all number
    51
    13
    31
    Abdominal pain
         subjects affected / exposed
    38 / 12503 (0.30%)
    24 / 6226 (0.39%)
    21 / 6243 (0.34%)
         occurrences all number
    41
    25
    21
    Toothache
         subjects affected / exposed
    35 / 12503 (0.28%)
    22 / 6226 (0.35%)
    19 / 6243 (0.30%)
         occurrences all number
    35
    24
    19
    Constipation
         subjects affected / exposed
    25 / 12503 (0.20%)
    22 / 6226 (0.35%)
    20 / 6243 (0.32%)
         occurrences all number
    28
    22
    21
    Dyspepsia
         subjects affected / exposed
    24 / 12503 (0.19%)
    12 / 6226 (0.19%)
    14 / 6243 (0.22%)
         occurrences all number
    24
    13
    15
    Gastritis
         subjects affected / exposed
    21 / 12503 (0.17%)
    9 / 6226 (0.14%)
    8 / 6243 (0.13%)
         occurrences all number
    21
    9
    8
    Dental caries
         subjects affected / exposed
    21 / 12503 (0.17%)
    2 / 6226 (0.03%)
    8 / 6243 (0.13%)
         occurrences all number
    22
    2
    8
    Large intestine polyp
         subjects affected / exposed
    14 / 12503 (0.11%)
    6 / 6226 (0.10%)
    11 / 6243 (0.18%)
         occurrences all number
    14
    7
    12
    Abdominal discomfort
         subjects affected / exposed
    13 / 12503 (0.10%)
    7 / 6226 (0.11%)
    8 / 6243 (0.13%)
         occurrences all number
    13
    7
    8
    Inguinal hernia
         subjects affected / exposed
    7 / 12503 (0.06%)
    8 / 6226 (0.13%)
    11 / 6243 (0.18%)
         occurrences all number
    7
    8
    11
    Umbilical hernia
         subjects affected / exposed
    10 / 12503 (0.08%)
    6 / 6226 (0.10%)
    5 / 6243 (0.08%)
         occurrences all number
    11
    6
    5
    Haemorrhoids
         subjects affected / exposed
    11 / 12503 (0.09%)
    2 / 6226 (0.03%)
    7 / 6243 (0.11%)
         occurrences all number
    11
    2
    7
    Dry mouth
         subjects affected / exposed
    11 / 12503 (0.09%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences all number
    11
    5
    5
    Hiatus hernia
         subjects affected / exposed
    7 / 12503 (0.06%)
    5 / 6226 (0.08%)
    7 / 6243 (0.11%)
         occurrences all number
    7
    5
    7
    Dysphagia
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences all number
    7
    2
    5
    Abdominal pain lower
         subjects affected / exposed
    6 / 12503 (0.05%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences all number
    6
    3
    3
    Irritable bowel syndrome
         subjects affected / exposed
    3 / 12503 (0.02%)
    5 / 6226 (0.08%)
    4 / 6243 (0.06%)
         occurrences all number
    4
    5
    4
    Mouth ulceration
         subjects affected / exposed
    5 / 12503 (0.04%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    3
    2
    Colitis
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    2
    2
    Diverticulum intestinal
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    5 / 6243 (0.08%)
         occurrences all number
    3
    1
    5
    Flatulence
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    2
    2
    Gastric ulcer
         subjects affected / exposed
    6 / 12503 (0.05%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    6
    2
    1
    Diverticulum
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    5
    2
    0
    Anal fissure
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    0
    2
    Anal incontinence
         subjects affected / exposed
    1 / 12503 (0.01%)
    4 / 6226 (0.06%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    4
    1
    Frequent bowel movements
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    1
    1
    Gingival pain
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    3
    0
    3
    Abdominal distension
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    5
    0
    0
    Abdominal hernia
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Colitis microscopic
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    0
    3
    Colitis ulcerative
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    2
    1
    Faeces discoloured
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    0
    1
    4
    Gastrointestinal pain
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    5
    0
    0
    Haematochezia
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    1
    1
    Impaired gastric emptying
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Odynophagia
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    0
    3
    Salivary hypersecretion
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    3
    0
    Stomatitis
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    5
    2
    0
    Barrett's oesophagus
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    2
    0
    Glossodynia
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    0
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    2
    2
    Aphthous ulcer
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Cheilitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    1
    2
    Chronic gastritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    2
    1
    Enteritis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Haematemesis
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    2
    1
    Intestinal obstruction
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Intestinal polyp
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    2
    1
    Melaena
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Pancreatic cyst
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Pancreatic failure
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    0
    2
    Peptic ulcer
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Abdominal mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Bile acid malabsorption
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Coeliac disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Epiploic appendagitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Crohn's disease
         subjects affected / exposed
    0 / 12503 (0.00%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    3
    1
    Faeces soft
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    2
    0
    Gastritis erosive
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    2
    1
    Periodontal disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    2
    1
    Gastrointestinal tract irritation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Duodenal polyp
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Glossitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Lip pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Noninfective gingivitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Oral disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Pancreatitis chronic
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Pharyngo-oesophageal diverticulum
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Rectal polyp
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Rectal tenesmus
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Regurgitation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Swollen tongue
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Abdominal symptom
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal tenderness
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Abnormal faeces
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Anal eczema
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Anal fistula
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Angular cheilitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Anorectal discomfort
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Appendix disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Ascites
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Diverticulum oesophageal
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Gingival disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Oesophagitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Oral papule
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pancreatic disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pancreatic mass
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Duodenitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Duodenogastric reflux
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Erosive oesophagitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Gastric cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Gastric polyps
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Gingival recession
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival swelling
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Gingival ulceration
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Inflammatory bowel disease
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Intestinal ischaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Lip disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Malabsorption
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Mechanical ileus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Mesenteric artery stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Mouth haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Oesophageal achalasia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Oesophageal disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Oral mucosal exfoliation
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pancreatic steatosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pancreatitis acute
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Parotid gland enlargement
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Precancerous lesion of digestive tract
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Proctitis ulcerative
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pyloric sphincter insufficiency
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Reflux gastritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Salivary duct obstruction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Salivary gland calculus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Salivary gland pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Steatorrhoea
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Tongue coated
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Tongue disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Tongue dry
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Tongue ulceration
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth deposit
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Pancreatitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    21 / 12503 (0.17%)
    12 / 6226 (0.19%)
    13 / 6243 (0.21%)
         occurrences all number
    21
    13
    13
    Rash
         subjects affected / exposed
    36 / 12503 (0.29%)
    31 / 6226 (0.50%)
    36 / 6243 (0.58%)
         occurrences all number
    36
    31
    36
    Pruritus
         subjects affected / exposed
    34 / 12503 (0.27%)
    24 / 6226 (0.39%)
    17 / 6243 (0.27%)
         occurrences all number
    34
    25
    17
    Ecchymosis
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    2
    0
    Dermal cyst
         subjects affected / exposed
    6 / 12503 (0.05%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    7
    1
    0
    Angioedema
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Blister
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Hand dermatitis
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    1
    0
    Hyperkeratosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Lichen planus
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    2
    0
    Erythema
         subjects affected / exposed
    17 / 12503 (0.14%)
    6 / 6226 (0.10%)
    13 / 6243 (0.21%)
         occurrences all number
    17
    6
    13
    Urticaria
         subjects affected / exposed
    13 / 12503 (0.10%)
    14 / 6226 (0.22%)
    7 / 6243 (0.11%)
         occurrences all number
    13
    15
    8
    Eczema
         subjects affected / exposed
    15 / 12503 (0.12%)
    9 / 6226 (0.14%)
    8 / 6243 (0.13%)
         occurrences all number
    16
    9
    8
    Skin lesion
         subjects affected / exposed
    7 / 12503 (0.06%)
    12 / 6226 (0.19%)
    8 / 6243 (0.13%)
         occurrences all number
    7
    14
    10
    Dermatitis
         subjects affected / exposed
    12 / 12503 (0.10%)
    4 / 6226 (0.06%)
    7 / 6243 (0.11%)
         occurrences all number
    12
    4
    7
    Dermatitis contact
         subjects affected / exposed
    11 / 12503 (0.09%)
    7 / 6226 (0.11%)
    4 / 6243 (0.06%)
         occurrences all number
    12
    7
    4
    Actinic keratosis
         subjects affected / exposed
    13 / 12503 (0.10%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    14
    1
    4
    Skin ulcer
         subjects affected / exposed
    8 / 12503 (0.06%)
    2 / 6226 (0.03%)
    7 / 6243 (0.11%)
         occurrences all number
    9
    2
    7
    Psoriasis
         subjects affected / exposed
    7 / 12503 (0.06%)
    3 / 6226 (0.05%)
    6 / 6243 (0.10%)
         occurrences all number
    7
    3
    6
    Night sweats
         subjects affected / exposed
    4 / 12503 (0.03%)
    5 / 6226 (0.08%)
    6 / 6243 (0.10%)
         occurrences all number
    4
    5
    6
    Alopecia
         subjects affected / exposed
    4 / 12503 (0.03%)
    6 / 6226 (0.10%)
    3 / 6243 (0.05%)
         occurrences all number
    4
    6
    3
    Dermatitis allergic
         subjects affected / exposed
    8 / 12503 (0.06%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    8
    1
    4
    Rash pruritic
         subjects affected / exposed
    3 / 12503 (0.02%)
    5 / 6226 (0.08%)
    2 / 6243 (0.03%)
         occurrences all number
    6
    5
    2
    Ingrowing nail
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    3
    2
    Acne
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Skin irritation
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Rosacea
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Lichen sclerosus
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    0
    2
    Pain of skin
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    0
    2
    Precancerous skin lesion
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Rash macular
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Rash papular
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    0
    2
    Skin exfoliation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    0
    2
    Skin warm
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Blood blister
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Cold sweat
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Cutaneous lupus erythematosus
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Decubitus ulcer
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Diabetic foot
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Erythema multiforme
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Excessive granulation tissue
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Granuloma annulare
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Haemorrhage subcutaneous
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Intertrigo
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Miliaria
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Neurodermatitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Dermatitis atopic
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Sensitive skin
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Onychogryphosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Skin reaction
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Alopecia scarring
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Androgenetic alopecia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis bullous
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Drug eruption
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema asteatotic
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Eczema nummular
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Hidradenitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Keloid scar
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Lentigo
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Lichen planopilaris
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Mechanical urticaria
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Milia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Myxoid cyst
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Nail bed bleeding
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Nail bed inflammation
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Nail disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Nail ridging
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Onychoclasis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Skin discolouration
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Pruritus allergic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Purpura senile
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Rash vesicular
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Sebaceous gland disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Skin erosion
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Skin fissures
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Skin lesion inflammation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Skin mass
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Spider naevus
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Telangiectasia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Transient acantholytic dermatosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Vitiligo
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Onycholysis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Papule
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pemphigus
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Perioral dermatitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Petechiae
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Photodermatosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pigmentation disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Pityriasis rosea
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Prurigo
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    16 / 12503 (0.13%)
    10 / 6226 (0.16%)
    7 / 6243 (0.11%)
         occurrences all number
    16
    10
    7
    Hypertonic bladder
         subjects affected / exposed
    13 / 12503 (0.10%)
    8 / 6226 (0.13%)
    5 / 6243 (0.08%)
         occurrences all number
    13
    8
    5
    Haematuria
         subjects affected / exposed
    10 / 12503 (0.08%)
    4 / 6226 (0.06%)
    5 / 6243 (0.08%)
         occurrences all number
    10
    4
    5
    Pollakiuria
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    9 / 6243 (0.14%)
         occurrences all number
    7
    2
    9
    Urinary incontinence
         subjects affected / exposed
    8 / 12503 (0.06%)
    3 / 6226 (0.05%)
    7 / 6243 (0.11%)
         occurrences all number
    8
    3
    7
    Chronic kidney disease
         subjects affected / exposed
    8 / 12503 (0.06%)
    7 / 6226 (0.11%)
    2 / 6243 (0.03%)
         occurrences all number
    8
    7
    2
    Dysuria
         subjects affected / exposed
    8 / 12503 (0.06%)
    5 / 6226 (0.08%)
    3 / 6243 (0.05%)
         occurrences all number
    8
    5
    3
    Renal cyst
         subjects affected / exposed
    3 / 12503 (0.02%)
    7 / 6226 (0.11%)
    6 / 6243 (0.10%)
         occurrences all number
    3
    7
    6
    Urinary retention
         subjects affected / exposed
    7 / 12503 (0.06%)
    3 / 6226 (0.05%)
    6 / 6243 (0.10%)
         occurrences all number
    7
    3
    6
    Renal failure
         subjects affected / exposed
    7 / 12503 (0.06%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    7
    0
    2
    Urinary tract inflammation
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    1
    2
    Acute kidney injury
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    2
    0
    Micturition urgency
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    1
    1
    3
    Renal colic
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    5
    0
    1
    Microalbuminuria
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Cystitis noninfective
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    0
    0
    Stress urinary incontinence
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Bladder dysfunction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Cystitis interstitial
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Lower urinary tract symptoms
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Nephropathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Nocturia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Renal atrophy
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Renal disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Renal mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Urge incontinence
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Urinary tract disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Calculus bladder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Chromaturia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Diabetic nephropathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    End stage renal disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hydronephrosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hypotonic urinary bladder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Incontinence
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Ketonuria
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Renal impairment
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Proteinuria
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Renal cyst haemorrhage
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Renal cyst ruptured
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Renal pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Urethral disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Urinary hesitation
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vesical fistula
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Polyuria
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    24 / 12503 (0.19%)
    10 / 6226 (0.16%)
    9 / 6243 (0.14%)
         occurrences all number
    25
    10
    9
    Thyroid mass
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    7
    2
    2
    Goitre
         subjects affected / exposed
    6 / 12503 (0.05%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    6
    1
    1
    Hypogonadism
         subjects affected / exposed
    2 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    2
    1
    Graves' disease
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    2
    0
    Adrenal mass
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Autoimmune hypothyroidism
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Primary hypothyroidism
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Thyroid cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Toxic nodular goitre
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperthyroidism
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    7
    2
    2
    Musculoskeletal and connective tissue disorders
    Osteopenia
         subjects affected / exposed
    17 / 12503 (0.14%)
    9 / 6226 (0.14%)
    8 / 6243 (0.13%)
         occurrences all number
    17
    9
    8
    Rotator cuff syndrome
         subjects affected / exposed
    22 / 12503 (0.18%)
    10 / 6226 (0.16%)
    10 / 6243 (0.16%)
         occurrences all number
    22
    10
    10
    Spinal osteoarthritis
         subjects affected / exposed
    12 / 12503 (0.10%)
    8 / 6226 (0.13%)
    10 / 6243 (0.16%)
         occurrences all number
    12
    9
    10
    Arthralgia
         subjects affected / exposed
    299 / 12503 (2.39%)
    226 / 6226 (3.63%)
    261 / 6243 (4.18%)
         occurrences all number
    343
    245
    300
    Myalgia
         subjects affected / exposed
    205 / 12503 (1.64%)
    228 / 6226 (3.66%)
    307 / 6243 (4.92%)
         occurrences all number
    237
    249
    362
    Back pain
         subjects affected / exposed
    181 / 12503 (1.45%)
    87 / 6226 (1.40%)
    93 / 6243 (1.49%)
         occurrences all number
    195
    91
    100
    Pain in extremity
         subjects affected / exposed
    98 / 12503 (0.78%)
    82 / 6226 (1.32%)
    91 / 6243 (1.46%)
         occurrences all number
    103
    89
    99
    Osteoarthritis
         subjects affected / exposed
    86 / 12503 (0.69%)
    49 / 6226 (0.79%)
    53 / 6243 (0.85%)
         occurrences all number
    86
    49
    57
    Neck pain
         subjects affected / exposed
    51 / 12503 (0.41%)
    25 / 6226 (0.40%)
    35 / 6243 (0.56%)
         occurrences all number
    52
    28
    36
    Muscle spasms
         subjects affected / exposed
    33 / 12503 (0.26%)
    22 / 6226 (0.35%)
    23 / 6243 (0.37%)
         occurrences all number
    34
    22
    25
    Arthritis
         subjects affected / exposed
    26 / 12503 (0.21%)
    16 / 6226 (0.26%)
    12 / 6243 (0.19%)
         occurrences all number
    27
    17
    12
    Osteoporosis
         subjects affected / exposed
    30 / 12503 (0.24%)
    13 / 6226 (0.21%)
    9 / 6243 (0.14%)
         occurrences all number
    30
    13
    9
    Bursitis
         subjects affected / exposed
    22 / 12503 (0.18%)
    11 / 6226 (0.18%)
    14 / 6243 (0.22%)
         occurrences all number
    22
    11
    14
    Musculoskeletal stiffness
         subjects affected / exposed
    15 / 12503 (0.12%)
    12 / 6226 (0.19%)
    18 / 6243 (0.29%)
         occurrences all number
    15
    13
    19
    Musculoskeletal chest pain
         subjects affected / exposed
    15 / 12503 (0.12%)
    11 / 6226 (0.18%)
    6 / 6243 (0.10%)
         occurrences all number
    16
    12
    6
    Joint swelling
         subjects affected / exposed
    16 / 12503 (0.13%)
    8 / 6226 (0.13%)
    4 / 6243 (0.06%)
         occurrences all number
    16
    8
    4
    Muscle tightness
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    1
    2
    Polymyalgia rheumatica
         subjects affected / exposed
    17 / 12503 (0.14%)
    8 / 6226 (0.13%)
    3 / 6243 (0.05%)
         occurrences all number
    17
    8
    3
    Intervertebral disc protrusion
         subjects affected / exposed
    14 / 12503 (0.11%)
    6 / 6226 (0.10%)
    2 / 6243 (0.03%)
         occurrences all number
    14
    6
    2
    Muscular weakness
         subjects affected / exposed
    7 / 12503 (0.06%)
    6 / 6226 (0.10%)
    5 / 6243 (0.08%)
         occurrences all number
    7
    6
    5
    Rheumatoid arthritis
         subjects affected / exposed
    10 / 12503 (0.08%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences all number
    11
    4
    4
    Trigger finger
         subjects affected / exposed
    8 / 12503 (0.06%)
    2 / 6226 (0.03%)
    7 / 6243 (0.11%)
         occurrences all number
    8
    2
    7
    Spinal pain
         subjects affected / exposed
    3 / 12503 (0.02%)
    7 / 6226 (0.11%)
    6 / 6243 (0.10%)
         occurrences all number
    3
    7
    6
    Spinal stenosis
         subjects affected / exposed
    6 / 12503 (0.05%)
    5 / 6226 (0.08%)
    5 / 6243 (0.08%)
         occurrences all number
    6
    5
    5
    Foot deformity
         subjects affected / exposed
    9 / 12503 (0.07%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    9
    4
    2
    Plantar fasciitis
         subjects affected / exposed
    9 / 12503 (0.07%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    9
    4
    2
    Tendonitis
         subjects affected / exposed
    7 / 12503 (0.06%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences all number
    7
    4
    4
    Bone pain
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    7 / 6243 (0.11%)
         occurrences all number
    4
    2
    7
    Intervertebral disc degeneration
         subjects affected / exposed
    7 / 12503 (0.06%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences all number
    7
    3
    3
    Exostosis
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    5 / 6243 (0.08%)
         occurrences all number
    4
    3
    5
    Synovial cyst
         subjects affected / exposed
    8 / 12503 (0.06%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    8
    2
    2
    Psoriatic arthropathy
         subjects affected / exposed
    8 / 12503 (0.06%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    8
    2
    1
    Groin pain
         subjects affected / exposed
    2 / 12503 (0.02%)
    7 / 6226 (0.11%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    8
    1
    Limb discomfort
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences all number
    3
    2
    5
    Musculoskeletal discomfort
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    4 / 6243 (0.06%)
         occurrences all number
    5
    0
    4
    Flank pain
         subjects affected / exposed
    2 / 12503 (0.02%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    4
    2
    Lumbar spinal stenosis
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    1
    2
    Musculoskeletal pain
         subjects affected / exposed
    12 / 12503 (0.10%)
    6 / 6226 (0.10%)
    10 / 6243 (0.16%)
         occurrences all number
    12
    6
    10
    Pain in jaw
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    4
    2
    3
    Arthritis reactive
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Tendon disorder
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    1
    1
    Dupuytren's contracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    3
    0
    Fibromyalgia
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    2
    2
    Greater trochanteric pain syndrome
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    0
    2
    Intervertebral disc disorder
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    2
    0
    Scoliosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    2
    2
    Costochondritis
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    0
    0
    Sacral pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    1
    1
    2
    Sacroiliitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    3
    0
    Temporomandibular pain and dysfunction syndrome
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    2
    Intervertebral disc compression
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Joint effusion
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Joint stiffness
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Mobility decreased
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    1
    2
    Muscle contracture
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Osteochondrosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Osteonecrosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Polyarthritis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Sacroiliac joint dysfunction
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Tenosynovitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    1
    2
    Periarthritis
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    3
    2
    Back disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Articular calcification
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Bone disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bone loss
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Chondritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Chondrocalcinosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Chondropathy
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Coccydynia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Axillary mass
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Clubbing
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Diastasis recti abdominis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Joint range of motion decreased
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Meniscopathy
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Muscle fatigue
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Palindromic rheumatism
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Pathological fracture
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Sjogren's syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Systemic lupus erythematosus
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Vertebral foraminal stenosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Arthropathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bone callus excessive
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Diffuse idiopathic skeletal hyperostosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Soft tissue mass
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Exostosis of jaw
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Gouty tophus
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Infrapatellar fat pad inflammation
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Intervertebral disc annular tear
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Joint hyperextension
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Joint instability
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Joint lock
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Ligament pain
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Limb deformity
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Mastication disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Metatarsalgia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle discomfort
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle swelling
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Neck mass
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Osteomalacia
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Polychondritis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Rheumatic disorder
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Scleroderma
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Seronegative arthritis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus tarsi syndrome
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Enthesopathy
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal disorder
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Spondylitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Spondylolisthesis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Tendon pain
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Torticollis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal ligament ossification
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    526 / 12503 (4.21%)
    244 / 6226 (3.92%)
    243 / 6243 (3.89%)
         occurrences all number
    638
    288
    298
    Bronchitis
         subjects affected / exposed
    204 / 12503 (1.63%)
    126 / 6226 (2.02%)
    99 / 6243 (1.59%)
         occurrences all number
    220
    139
    103
    Urinary tract infection
         subjects affected / exposed
    184 / 12503 (1.47%)
    85 / 6226 (1.37%)
    92 / 6243 (1.47%)
         occurrences all number
    214
    95
    106
    Nasopharyngitis
         subjects affected / exposed
    178 / 12503 (1.42%)
    90 / 6226 (1.45%)
    89 / 6243 (1.43%)
         occurrences all number
    190
    96
    92
    Respiratory tract infection
         subjects affected / exposed
    93 / 12503 (0.74%)
    54 / 6226 (0.87%)
    53 / 6243 (0.85%)
         occurrences all number
    96
    59
    57
    Sinusitis
         subjects affected / exposed
    90 / 12503 (0.72%)
    42 / 6226 (0.67%)
    46 / 6243 (0.74%)
         occurrences all number
    97
    44
    51
    Lower respiratory tract infection
         subjects affected / exposed
    61 / 12503 (0.49%)
    24 / 6226 (0.39%)
    31 / 6243 (0.50%)
         occurrences all number
    66
    26
    35
    Rhinitis
         subjects affected / exposed
    52 / 12503 (0.42%)
    28 / 6226 (0.45%)
    30 / 6243 (0.48%)
         occurrences all number
    52
    33
    32
    Pneumonia
         subjects affected / exposed
    61 / 12503 (0.49%)
    29 / 6226 (0.47%)
    19 / 6243 (0.30%)
         occurrences all number
    62
    29
    20
    Viral upper respiratory tract infection
         subjects affected / exposed
    48 / 12503 (0.38%)
    28 / 6226 (0.45%)
    25 / 6243 (0.40%)
         occurrences all number
    55
    32
    35
    Herpes zoster
         subjects affected / exposed
    49 / 12503 (0.39%)
    17 / 6226 (0.27%)
    31 / 6243 (0.50%)
         occurrences all number
    52
    18
    32
    Cystitis
         subjects affected / exposed
    43 / 12503 (0.34%)
    23 / 6226 (0.37%)
    18 / 6243 (0.29%)
         occurrences all number
    45
    27
    19
    Gastroenteritis
         subjects affected / exposed
    36 / 12503 (0.29%)
    25 / 6226 (0.40%)
    14 / 6243 (0.22%)
         occurrences all number
    36
    25
    15
    Influenza
         subjects affected / exposed
    30 / 12503 (0.24%)
    20 / 6226 (0.32%)
    24 / 6243 (0.38%)
         occurrences all number
    31
    20
    25
    Cellulitis
         subjects affected / exposed
    34 / 12503 (0.27%)
    14 / 6226 (0.22%)
    17 / 6243 (0.27%)
         occurrences all number
    36
    15
    17
    Oral herpes
         subjects affected / exposed
    31 / 12503 (0.25%)
    17 / 6226 (0.27%)
    17 / 6243 (0.27%)
         occurrences all number
    31
    17
    19
    Conjunctivitis
         subjects affected / exposed
    33 / 12503 (0.26%)
    9 / 6226 (0.14%)
    19 / 6243 (0.30%)
         occurrences all number
    34
    9
    20
    Ear infection
         subjects affected / exposed
    29 / 12503 (0.23%)
    14 / 6226 (0.22%)
    13 / 6243 (0.21%)
         occurrences all number
    32
    16
    13
    COVID-19
         subjects affected / exposed
    1178 / 12503 (9.42%)
    600 / 6226 (9.64%)
    601 / 6243 (9.63%)
         occurrences all number
    1283
    656
    647
    Tooth infection
         subjects affected / exposed
    27 / 12503 (0.22%)
    16 / 6226 (0.26%)
    9 / 6243 (0.14%)
         occurrences all number
    27
    16
    9
    COVID-19 pneumonia
         subjects affected / exposed
    8 / 12503 (0.06%)
    2 / 6226 (0.03%)
    4 / 6243 (0.06%)
         occurrences all number
    8
    2
    4
    Diverticulitis
         subjects affected / exposed
    23 / 12503 (0.18%)
    11 / 6226 (0.18%)
    9 / 6243 (0.14%)
         occurrences all number
    25
    13
    10
    Pharyngitis
         subjects affected / exposed
    21 / 12503 (0.17%)
    14 / 6226 (0.22%)
    8 / 6243 (0.13%)
         occurrences all number
    21
    15
    8
    Respiratory tract infection viral
         subjects affected / exposed
    11 / 12503 (0.09%)
    11 / 6226 (0.18%)
    12 / 6243 (0.19%)
         occurrences all number
    11
    12
    12
    Localised infection
         subjects affected / exposed
    15 / 12503 (0.12%)
    9 / 6226 (0.14%)
    9 / 6243 (0.14%)
         occurrences all number
    15
    10
    9
    Acute sinusitis
         subjects affected / exposed
    13 / 12503 (0.10%)
    9 / 6226 (0.14%)
    8 / 6243 (0.13%)
         occurrences all number
    13
    9
    12
    Suspected COVID-19
         subjects affected / exposed
    14 / 12503 (0.11%)
    7 / 6226 (0.11%)
    8 / 6243 (0.13%)
         occurrences all number
    14
    8
    8
    Gingivitis
         subjects affected / exposed
    10 / 12503 (0.08%)
    7 / 6226 (0.11%)
    9 / 6243 (0.14%)
         occurrences all number
    11
    7
    9
    Viral infection
         subjects affected / exposed
    12 / 12503 (0.10%)
    2 / 6226 (0.03%)
    10 / 6243 (0.16%)
         occurrences all number
    12
    2
    10
    Otitis media
         subjects affected / exposed
    10 / 12503 (0.08%)
    4 / 6226 (0.06%)
    9 / 6243 (0.14%)
         occurrences all number
    11
    4
    9
    Hordeolum
         subjects affected / exposed
    8 / 12503 (0.06%)
    8 / 6226 (0.13%)
    6 / 6243 (0.10%)
         occurrences all number
    8
    8
    6
    Laryngitis
         subjects affected / exposed
    9 / 12503 (0.07%)
    7 / 6226 (0.11%)
    6 / 6243 (0.10%)
         occurrences all number
    9
    7
    6
    Lower respiratory tract infection viral
         subjects affected / exposed
    9 / 12503 (0.07%)
    8 / 6226 (0.13%)
    5 / 6243 (0.08%)
         occurrences all number
    9
    8
    5
    Otitis externa
         subjects affected / exposed
    12 / 12503 (0.10%)
    4 / 6226 (0.06%)
    5 / 6243 (0.08%)
         occurrences all number
    12
    6
    5
    Gastroenteritis viral
         subjects affected / exposed
    10 / 12503 (0.08%)
    6 / 6226 (0.10%)
    4 / 6243 (0.06%)
         occurrences all number
    10
    6
    4
    Eye infection
         subjects affected / exposed
    6 / 12503 (0.05%)
    6 / 6226 (0.10%)
    5 / 6243 (0.08%)
         occurrences all number
    7
    6
    5
    Fungal infection
         subjects affected / exposed
    7 / 12503 (0.06%)
    3 / 6226 (0.05%)
    7 / 6243 (0.11%)
         occurrences all number
    7
    4
    7
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    8 / 12503 (0.06%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences all number
    8
    4
    4
    Helicobacter infection
         subjects affected / exposed
    6 / 12503 (0.05%)
    1 / 6226 (0.02%)
    8 / 6243 (0.13%)
         occurrences all number
    6
    1
    8
    Kidney infection
         subjects affected / exposed
    7 / 12503 (0.06%)
    2 / 6226 (0.03%)
    6 / 6243 (0.10%)
         occurrences all number
    7
    2
    6
    Tooth abscess
         subjects affected / exposed
    26 / 12503 (0.21%)
    12 / 6226 (0.19%)
    13 / 6243 (0.21%)
         occurrences all number
    27
    13
    13
    Onychomycosis
         subjects affected / exposed
    7 / 12503 (0.06%)
    4 / 6226 (0.06%)
    3 / 6243 (0.05%)
         occurrences all number
    7
    4
    3
    Herpes virus infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    2
    1
    4
    Herpes simplex
         subjects affected / exposed
    8 / 12503 (0.06%)
    4 / 6226 (0.06%)
    1 / 6243 (0.02%)
         occurrences all number
    9
    4
    1
    Paronychia
         subjects affected / exposed
    5 / 12503 (0.04%)
    4 / 6226 (0.06%)
    3 / 6243 (0.05%)
         occurrences all number
    5
    4
    3
    Skin infection
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    5 / 6243 (0.08%)
         occurrences all number
    5
    2
    6
    Candida infection
         subjects affected / exposed
    8 / 12503 (0.06%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    8
    0
    3
    Erysipelas
         subjects affected / exposed
    5 / 12503 (0.04%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    6
    2
    Oral candidiasis
         subjects affected / exposed
    4 / 12503 (0.03%)
    3 / 6226 (0.05%)
    4 / 6243 (0.06%)
         occurrences all number
    4
    3
    4
    Vulvovaginal candidiasis
         subjects affected / exposed
    6 / 12503 (0.05%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    6
    2
    2
    Wound infection
         subjects affected / exposed
    4 / 12503 (0.03%)
    5 / 6226 (0.08%)
    1 / 6243 (0.02%)
         occurrences all number
    4
    5
    2
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    7 / 12503 (0.06%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    7
    1
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences all number
    4
    2
    3
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    2 / 12503 (0.02%)
    4 / 6226 (0.06%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    4
    3
    Tinea pedis
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    5 / 6243 (0.08%)
         occurrences all number
    4
    1
    5
    Chronic sinusitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    4 / 6243 (0.06%)
         occurrences all number
    1
    3
    4
    Lyme disease
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    3 / 6243 (0.05%)
         occurrences all number
    3
    2
    3
    Tracheobronchitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    4 / 6226 (0.06%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    4
    2
    Bronchitis viral
         subjects affected / exposed
    1 / 12503 (0.01%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences all number
    1
    3
    3
    Fungal skin infection
         subjects affected / exposed
    5 / 12503 (0.04%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    5
    2
    0
    Furuncle
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    2
    2
    Gastrointestinal infection
         subjects affected / exposed
    4 / 12503 (0.03%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    1
    2
    Periodontitis
         subjects affected / exposed
    9 / 12503 (0.07%)
    4 / 6226 (0.06%)
    1 / 6243 (0.02%)
         occurrences all number
    9
    4
    1
    Infective exacerbation of asthma
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    3
    1
    Infected skin ulcer
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    0
    2
    Post procedural infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    3
    2
    Pulpitis dental
         subjects affected / exposed
    4 / 12503 (0.03%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    5
    2
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    3 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    3
    1
    Rhinovirus infection
         subjects affected / exposed
    5 / 12503 (0.04%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    5
    1
    1
    Acarodermatitis
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    1
    2
    Infected bite
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    3
    1
    Postoperative wound infection
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    0
    2
    Staphylococcal infection
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    2
    1
    Tonsillitis
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    4
    1
    2
    Folliculitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    2
    0
    4
    Nail infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    3
    0
    Pulmonary tuberculosis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    1
    2
    Tinea cruris
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    1
    1
    Tracheitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    4 / 6243 (0.06%)
         occurrences all number
    0
    1
    4
    Bacterial vaginosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    2
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    2
    1
    Impetigo
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    0
    2
    Infected dermal cyst
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Otitis media acute
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    3 / 6243 (0.05%)
         occurrences all number
    3
    1
    3
    Pyelonephritis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    2
    0
    2
    Viral sinusitis
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Vaginal infection
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    3
    0
    1
    Viral pharyngitis
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    1
    0
    Vulvitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    4 / 12503 (0.03%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    0
    0
    Abscess oral
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Arthritis infective
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Body tinea
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Breast abscess
         subjects affected / exposed
    3 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Device related infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Fungal foot infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Genital infection fungal
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    1
    2
    Helicobacter gastritis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Hepatitis C
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Infected cyst
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    3 / 6243 (0.05%)
         occurrences all number
    0
    0
    3
    Latent tuberculosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    1
    1
    Nail bed infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Orchitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    0
    1
    Urethritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    2
    1
    Subcutaneous abscess
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    2
    1
    1
    Abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Bronchitis bacterial
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Conjunctivitis bacterial
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Dermatophytosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Dermatophytosis of nail
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Dientamoeba infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Dysentery
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Eczema infected
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Enterovirus infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Epididymitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Escherichia infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Fungal oesophagitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Gastric infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Groin abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Labyrinthitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Laryngitis bacterial
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Laryngopharyngitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Norovirus infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Abscess limb
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Conjunctivitis viral
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Chlamydial infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Otitis media chronic
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Pertussis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Root canal infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Salmonellosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Sepsis
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Sialoadenitis
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Sinusitis bacterial
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Staphylococcal skin infection
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Tinea infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Viral rhinitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    2
    0
    Acariasis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Anal abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Appendicitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Atypical pneumonia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Bacterial infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchiolitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Campylobacter infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Osteomyelitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    1
    0
    1
    Coronavirus infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Herpes ophthalmic
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Dengue fever
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Dental gangrene
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis infected
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Diabetic foot infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Enterobacter infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Enterobiasis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Eyelid infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal pharyngitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Gangrene
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal bacterial infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal bacterial overgrowth
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Genital infection bacterial
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival abscess
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    HIV infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Haemophilus infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhoid infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Herpangina
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Histoplasmosis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Large intestine infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngitis viral
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Lyme arthritis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphangitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Mycoplasma infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Myiasis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal vestibulitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Oral fungal infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Oral infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Otitis externa fungal
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Parotitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Penile infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Perineal abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pilonidal disease
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia fungal
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Injection site pustule
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Tinea versicolour
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Varicella
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Vulval abscess
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Wound infection bacterial
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Postoperative abscess
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Prostate infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pyonephrosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Pyuria
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal abscess
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    2
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Retinitis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Rocky mountain spotted fever
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Scarlet fever
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Sebaceous gland infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Shigella infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Sinobronchitis
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Skin graft infection
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Stenotrophomonas infection
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Superinfection bacterial
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    4 / 6243 (0.06%)
         occurrences all number
    1
    0
    5
    Type 2 diabetes mellitus
         subjects affected / exposed
    55 / 12503 (0.44%)
    22 / 6226 (0.35%)
    39 / 6243 (0.62%)
         occurrences all number
    56
    22
    39
    Hypercholesterolaemia
         subjects affected / exposed
    60 / 12503 (0.48%)
    24 / 6226 (0.39%)
    20 / 6243 (0.32%)
         occurrences all number
    60
    25
    20
    Gout
         subjects affected / exposed
    36 / 12503 (0.29%)
    19 / 6226 (0.31%)
    20 / 6243 (0.32%)
         occurrences all number
    38
    20
    23
    Hyperlipidaemia
         subjects affected / exposed
    39 / 12503 (0.31%)
    13 / 6226 (0.21%)
    16 / 6243 (0.26%)
         occurrences all number
    39
    13
    16
    Decreased appetite
         subjects affected / exposed
    24 / 12503 (0.19%)
    19 / 6226 (0.31%)
    21 / 6243 (0.34%)
         occurrences all number
    24
    19
    22
    Vitamin D deficiency
         subjects affected / exposed
    21 / 12503 (0.17%)
    12 / 6226 (0.19%)
    18 / 6243 (0.29%)
         occurrences all number
    21
    12
    18
    Diabetes mellitus
         subjects affected / exposed
    20 / 12503 (0.16%)
    15 / 6226 (0.24%)
    11 / 6243 (0.18%)
         occurrences all number
    20
    16
    11
    Dyslipidaemia
         subjects affected / exposed
    20 / 12503 (0.16%)
    6 / 6226 (0.10%)
    6 / 6243 (0.10%)
         occurrences all number
    20
    6
    6
    Glucose tolerance impaired
         subjects affected / exposed
    17 / 12503 (0.14%)
    7 / 6226 (0.11%)
    8 / 6243 (0.13%)
         occurrences all number
    17
    7
    8
    Hyperuricaemia
         subjects affected / exposed
    9 / 12503 (0.07%)
    6 / 6226 (0.10%)
    7 / 6243 (0.11%)
         occurrences all number
    9
    6
    7
    Vitamin B12 deficiency
         subjects affected / exposed
    8 / 12503 (0.06%)
    4 / 6226 (0.06%)
    8 / 6243 (0.13%)
         occurrences all number
    8
    4
    8
    Hyperglycaemia
         subjects affected / exposed
    9 / 12503 (0.07%)
    3 / 6226 (0.05%)
    3 / 6243 (0.05%)
         occurrences all number
    9
    3
    3
    Hypokalaemia
         subjects affected / exposed
    6 / 12503 (0.05%)
    5 / 6226 (0.08%)
    3 / 6243 (0.05%)
         occurrences all number
    6
    5
    3
    Hypoglycaemia
         subjects affected / exposed
    4 / 12503 (0.03%)
    4 / 6226 (0.06%)
    4 / 6243 (0.06%)
         occurrences all number
    7
    4
    4
    Dehydration
         subjects affected / exposed
    6 / 12503 (0.05%)
    3 / 6226 (0.05%)
    0 / 6243 (0.00%)
         occurrences all number
    6
    3
    0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    4 / 12503 (0.03%)
    5 / 6226 (0.08%)
    0 / 6243 (0.00%)
         occurrences all number
    4
    5
    0
    Folate deficiency
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    5
    0
    2
    Iron deficiency
         subjects affected / exposed
    3 / 12503 (0.02%)
    2 / 6226 (0.03%)
    2 / 6243 (0.03%)
         occurrences all number
    3
    2
    2
    Hypomagnesaemia
         subjects affected / exposed
    5 / 12503 (0.04%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    5
    0
    1
    Impaired fasting glucose
         subjects affected / exposed
    3 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    3
    1
    0
    Hyponatraemia
         subjects affected / exposed
    2 / 12503 (0.02%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    1
    0
    Hypermagnesaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Insulin resistance
         subjects affected / exposed
    1 / 12503 (0.01%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    1
    0
    Obesity
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    2 / 6243 (0.03%)
         occurrences all number
    0
    0
    2
    Polydipsia
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    1
    1
    Vitamin B complex deficiency
         subjects affected / exposed
    2 / 12503 (0.02%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    2
    0
    0
    Calcium deficiency
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Enzyme abnormality
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Failure to thrive
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Gluten sensitivity
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hypervolaemia
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hypovitaminosis
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Increased appetite
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Lactose intolerance
         subjects affected / exposed
    0 / 12503 (0.00%)
    1 / 6226 (0.02%)
    0 / 6243 (0.00%)
         occurrences all number
    0
    1
    0
    Lipoedema
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Magnesium deficiency
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Overweight
         subjects affected / exposed
    0 / 12503 (0.00%)
    0 / 6226 (0.00%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    0
    1
    Vitamin B1 deficiency
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Vitamin B6 deficiency
         subjects affected / exposed
    1 / 12503 (0.01%)
    0 / 6226 (0.00%)
    0 / 6243 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 12503 (0.00%)
    2 / 6226 (0.03%)
    1 / 6243 (0.02%)
         occurrences all number
    0
    2
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2021
    The purpose of the amendment was to increase the enrollment number, as a consequence of the restrictive non-pharmaceutical measures put in place in several countries to control the COVID-19 pandemic.
    06 Oct 2021
    The purpose of the amendment was to adapt the trigger for the assessment of the primary objective to a case-driven basis only to allow for assessment of the primary objective once the required number of cases were accumulated. In addition, an optional interim analysis was included which was to be performed if the number of cases triggering the final analysis of the primary objective was not achieved at the end of Season 1 in NH. Additionally, the evaluation of efficacy against any acute respiratory infection (ARI) and any lower respiratory tract disease (LRTD) was moved to secondary descriptive objectives and the assessment of immunogenicity in terms of neutralizing antibodies against RSV B was added.
    24 Jan 2022
    he purpose of the amendment was to i) include the assessment of the efficacy of annual revaccination with the RSVPreF3 OA investigational vaccine, in addition to the assessment of efficacy over 3 seasons after a vaccination with a single dose, and ii) add the evaluation of efficacy against each RSV subtype independently as secondary confirmatory objectives at the end of the study, conditional to the number of cases accrued. Also, the evaluation of efficacy against human metapneumovirus (hMPV) was upgraded to a secondary confirmatory objective.
    23 Mar 2023
    The purpose of the amendment was to record events of atrial fibrillation (AF) as Adverse Events of Special Interest (AESIs) and to modify the blinding procedures at the sponsor level to reduce the complexity in communicating on study data with regulatory authorities.
    12 Jul 2023
    he purpose of the amendment was to remove Dose 3 administration before the start of Season 3 for participants in the NH and to add a blood sample at Visit 5NH for all participants who were not in the reactogenicity and immunogenicity subset.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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