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    Clinical Trial Results:
    Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate Efficacy and Safety of a Dengue 1, 2, 3, 4 (Attenuated) Vaccine produced by Instituto Butantan

    Summary
    EudraCT number
    		 2022-003868-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Jun 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Dec 2025
    First version publication date
    24 Dec 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DEN-03-IB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02406729
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 UTN: U1111-1168-8679
    Sponsors
    Sponsor organisation name
    Butantan Institute
    Sponsor organisation address
    Av. Vital Brasil, 1500, Butantã, São Paulo, Brazil, 05503-900
    Public contact
    Butantan Institute, Butantan Institute, 11 3723 2121,
    Scientific contact
    Butantan Institute, Butantan Institute, 11 3723 2121,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002999-PIP01-21
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Nov 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The goal of this study is to learn how well the Dengue 1,2,3,4 (attenuated) vaccine works at helping the body make antibodies against the 4 types of dengue virus (DENV) in participants aged 2 to 59 years old. Researchers also want to learn about the safety of V181 and how well older adults tolerate it.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Feb 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 16235
    Worldwide total number of subjects
    16235
    EEA total number of subjects
    0
    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)
    7812
    Adolescents (12-17 years)
    2351
    Adults (18-64 years)
    6072
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy participants between 2 and 59 years of age were enrolled into this 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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dengue 1,2,3,4 (Attenuated) Vaccine
    Arm description
    		 Participants received a single 0.5 mL subcutaneous (SC) dose of dengue 1,2,3,4 (attenuated) vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dengue 1,2,3,4 (Attenuated) Vaccine
    Investigational medicinal product code
    Other name
    Butantan DV TetraVax-DV-TV003
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL dose containing 1000 plaque-forming units per vaccine virus (1,2,3,4).

    Arm title
    		 Placebo
    Arm description
    		 Participants received a single 0.5 mL SC dose of placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL dose of dengue 1,2,3,4 (attenuated) vaccine-matching placebo.

    Number of subjects in period 1
    		Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Started
    10259
    5976
    Completed
    8801
    5092
    Not completed
    1458
    884
         Physician decision
    11
    6
         Consent withdrawn by subject
    753
    450
         Not Reported
    28
    13
         Death
    43
    34
         Lost to follow-up
    617
    380
         Consent withdrawn by Parent/Guardian
    6
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dengue 1,2,3,4 (Attenuated) Vaccine
    Reporting group description
    		 Participants received a single 0.5 mL subcutaneous (SC) dose of dengue 1,2,3,4 (attenuated) vaccine.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of placebo.

    Reporting group values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo Total
    Number of subjects
    		 10259 5976 16235
    Age Categorical
    Units: Participants
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 5185 2627 7812
        Adolescents (12-17 years)
    		 1528 823 2351
        Adults (18-64 years)
    		 3546 2526 6072
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 18.4 ( 16.6 ) 20.7 ( 17.1 ) -
    Gender Categorical
    Units: Participants
        Female
    		 5554 3213 8767
        Male
    		 4705 2763 7468
    Age Group
    Randomization of participants was stratified by age groups of 2 to 6 years of age, 7 to 17 years of age, or 18 to 59 years of age.
    Units: Subjects
        2 to 6 years of age
    		 3337 1679 5016
        7 to 17 years of age
    		 3376 1771 5147
        18 to 59 years of age
    		 3546 2526 6072

    End points

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    End points reporting groups
    Reporting group title
    Dengue 1,2,3,4 (Attenuated) Vaccine
    Reporting group description
    		 Participants received a single 0.5 mL subcutaneous (SC) dose of dengue 1,2,3,4 (attenuated) vaccine.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of placebo.

    Primary: Incidence Rate of Virologically Confirmed Dengue (VCD) Cases Regardless of Prior Exposure to Dengue Virus

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    End point title
    		 Incidence Rate of Virologically Confirmed Dengue (VCD) Cases Regardless of Prior Exposure to Dengue Virus
    End point description
    The incidence rate of VCD cases was defined as the number of VCD cases per 100 person-years at risk. The person-years at risk of each individual participant is the cumulative time (in years) until the participant was diagnosed with first symptomatic VCD episode or until the end of the study for each participant, whichever came first. The incidence rate for any serotype of dengue virus was reported. The analysis population consisted of the randomized participants, regardless of their prior exposure to dengue virus, who met the inclusion criteria and did not meet any exclusion criteria, received the investigational product to which they were randomized in accordance with the handling and administration conditions recommended by the manufacturer, did not use restricted medications, as per the protocol, and did not withdraw informed consent.
    End point type
    Primary
    End point timeframe
    Up to approximately 28 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    10209
    5940
    Units: Cases per 100 Person-Years at Risk
        number (confidence interval 95%)
    0.376 (0.323 to 0.436)
    1.074 (0.954 to 1.205)
    Statistical analysis title
    		 Vaccine Efficacy Percentage
    Statistical analysis description
    Vaccine efficacy was estimated based on the exact binomial method proposed by Chan and Bohidar, the 95% confidence interval (CI) was estimated using Blaker’s exact CI, and p-value were estimated from binomial exact method. The statistical criterion for success requires the lower bound of the 2-sided 95% CI for vaccine efficacy to be > 25%.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Binomial Exact Method
    Parameter type
    		 Vaccine Efficacy Percent
    Point estimate
    64.974
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 57.797
         upper limit
    		 71.024

    Primary: Number of Participants who Experienced a Solicited Adverse Drug Reaction (ADR) Through 21 Days Postvaccination

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    End point title
    		 Number of Participants who Experienced a Solicited Adverse Drug Reaction (ADR) Through 21 Days Postvaccination
    End point description
    An ADR was defined as an adverse event (AE) that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited administration site ADRs included erythema(redness), induration, pain, pruritus, and swelling. Solicited systemic ADRs included arthralgia, chills, eye pain (retro-orbital pain), fatigue (asthenia), headache, myalgia (muscle pain), nausea, photophobia, pruritus, pyrexia (fever), skin rash (exanthema), and vomiting. The number of participants who experienced a solicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Primary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    10259
    5976
    Units: Participants
    number (not applicable)
        Administration Site Erythema
    326
    94
        Administration Site Induration
    201
    96
        Administration Site Pain
    1536
    672
        Administration Site Pruritus
    587
    244
        Administration Site Swelling
    131
    68
        Arthralgia
    1162
    491
        Chills
    884
    335
        Eye Pain
    1636
    645
        Fatigue
    1995
    912
        Headache
    3768
    1860
        Myalgia
    1816
    766
        Nausea
    1257
    634
        Photophobia
    1000
    488
        Pruritus
    1977
    532
        Pyrexia
    1047
    398
        Skin Rash
    2326
    253
        Vomiting
    580
    298
    Statistical analysis title
    		 Dif in %-Administration Site Erythema
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 2.1
    Statistical analysis title
    		 Dif in %-Administration Site Induration
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.098
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.8
    Statistical analysis title
    		 Dif in %-Administration Site Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 4.7
    Statistical analysis title
    		 Dif in %-Administration Site Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference of Percentage
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 2.3
    Statistical analysis title
    		 Dif in %-Administration Site Swelling
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.356
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.5
    Statistical analysis title
    		 Dif in %-Arthralgia
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 4.9
    Statistical analysis title
    		 Dif in %-Chills
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 4.3
    Statistical analysis title
    		 Dif in %-Eye Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.9
         upper limit
    		 7
    Statistical analysis title
    		 Dif in %-Fatigue
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.1
         upper limit
    		 6.4
    Statistical analysis title
    		 Dif in %-Nausea
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 3.1
    Statistical analysis title
    		 Dif in %-Myalgia
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 7.1
    Statistical analysis title
    		 Dif in %-Headache
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.5
         upper limit
    		 8.4
    Statistical analysis title
    		 Dif in %-Photophobia
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 3
    Statistical analysis title
    		 Dif in %-Pyrexia
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.4
         upper limit
    		 4.1
    Statistical analysis title
    		 Dif in %-Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    10.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.9
         upper limit
    		 11.9
    Statistical analysis title
    		 Dif in %-Skin Rash
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    18.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.7
         upper limit
    		 19.6
    Statistical analysis title
    		 Dif in %-Vomiting
    Statistical analysis description
    Estimated differences, CIs, and p-value are calculated based on Miettinen & Nurminen method stratified by age group (2 to 6 years, 7 to 17 years or 18 to 59 years); if no participants are in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum is excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.182
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 1.2

    Primary: Number of Participants who Experienced an Unsolicited ADR Through 21 Days Postvaccination

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    End point title
    		 Number of Participants who Experienced an Unsolicited ADR Through 21 Days Postvaccination
    End point description
    An ADR was defined as an adverse event (AE) that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an unsolicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Primary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    10259
    5976
    Units: Participants
        number (not applicable)
    1386
    719
    Statistical analysis title
    		 Difference in %-Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method stratified by age group; if no participants were in one of the vaccination groups involved in a comparison for a particular stratum, then that stratum was excluded from the vaccination comparison.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 3

    Secondary: Incidence Rate of VCD Cases in Participants with Prior Exposure to Dengue Fever

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    End point title
    		 Incidence Rate of VCD Cases in Participants with Prior Exposure to Dengue Fever
    End point description
    The incidence rate of VCD cases was defined as the number of VCD cases per 100 person-years at risk. The person-years at risk of each individual participant is the cumulative time (in years) until the participant was diagnosed with first symptomatic VCD episode or until the end of the study for each participant, whichever came first. The incidence rate for any serotype of dengue virus was reported. The analysis population consisted of the randomized participants with prior exposure to dengue virus who met the inclusion criteria and did not meet any exclusion criteria, received the investigational product to which they were randomized in accordance with the handling and administration conditions recommended by the manufacturer, did not use restricted medications, as per the protocol, and did not withdraw informed consent.
    End point type
    Secondary
    End point timeframe
    Up to approximately 28 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    4985
    3023
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.198 (0.145 to 0.264)
    0.863 (0.715 to 1.032)
    Statistical analysis title
    		 Vaccine Efficacy %
    Statistical analysis description
    Vaccine efficacy was estimated based on the exact binomial method proposed by Chan and Bohidar, the 95% CI was estimated using Blaker’s exact CI, and p-values were estimated from binomial exact method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8008
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Binomial Exact Method
    Parameter type
    		 Vaccine Efficacy Percent
    Point estimate
    77.058
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 67.552
         upper limit
    		 83.867

    Secondary: Incidence Rate of VCD Cases in Participants without Prior Exposure to Dengue Fever

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    End point title
    		 Incidence Rate of VCD Cases in Participants without Prior Exposure to Dengue Fever
    End point description
    The incidence rate of VCD cases was defined as the number of VCD cases per 100 person-years at risk. The person-years at risk of each individual participant is the cumulative time (in years) until the participant was diagnosed with first symptomatic VCD episode or until the end of the study for each participant, whichever came first. The incidence rate for any serotype of dengue virus was reported. The analysis population consisted of the randomized participants without prior exposure to dengue virus who met the inclusion criteria and did not meet any exclusion criteria, received the investigational product to which they were randomized in accordance with the handling and administration conditions recommended by the manufacturer, did not use restricted medications, as per the protocol, and did not withdraw informed consent.
    End point type
    Secondary
    End point timeframe
    Up to approximately 28 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    4819
    2678
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.571 (0.475 to 0.680)
    1.387 (1.185 to 1.614)
    Statistical analysis title
    		 Vaccine Efficacy Percentage
    Statistical analysis description
    Vaccine efficacy was estimated based on the exact binomial method proposed by Chan and Bohidar, the 95% CI was estimated using Blaker’s exact CI, and p-value were estimated from binomial exact method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7497
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0019
    Method
    		 Binomial Exact Method
    Parameter type
    		 Vaccine Efficacy Percent
    Point estimate
    58.855
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47.971
         upper limit
    		 67.554

    Secondary: Incidence Rate of VCD Cases Reported by Viral Serotype

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    End point title
    		 Incidence Rate of VCD Cases Reported by Viral Serotype
    End point description
    The incidence rate of VCD cases was defined as the number of VCD cases per 100 person-years at risk. The person-years at risk of each individual participant is the cumulative time (in years) until the participant was diagnosed with first symptomatic VCD episode or until the end of the study for each participant, whichever came first. The incidence rate for each serotype of dengue virus was reported. Only dengue virus serotypes 1 and 2 were detected in this study. The analysis population consisted of the randomized participants who met the inclusion criteria and did not meet any exclusion criteria, received the investigational product to which they were randomized in accordance with the handling and administration conditions recommended by the manufacturer, did not use restricted medications, as per the protocol, and did not withdraw informed consent.
    End point type
    Secondary
    End point timeframe
    Up to approximately 28 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    10209
    5940
    Units: Cases per 100 Person-Years at Risk
    number (confidence interval 95%)
        Dengue Virus Serotype 1
    0.159 (0.125 to 0.199)
    0.588 (0.500 to 0.686)
        Dengue Virus Serotype 2
    0.216 (0.176 to 0.263)
    0.489 (0.409 to 0.579)
    Statistical analysis title
    		 Vaccine Efficiency %-DENV2
    Statistical analysis description
    Vaccine efficacy was estimated based on the exact binomial method proposed by Chan and Bohidar, the 95% CI was estimated using Blaker’s exact CI, and p-value were estimated from binomial exact method. The statistical criterion for success requires the lower bound of the 2-sided 95% CI for vaccine efficacy to be > 25%.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Binomial Exact Method
    Parameter type
    		 Vaccine Efficiency %
    Point estimate
    55.733
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42.339
         upper limit
    		 66.122
    Statistical analysis title
    		 Vaccine Efficacy %-DENV1
    Statistical analysis description
    Vaccine efficacy was estimated based on the exact binomial method proposed by Chan and Bohidar, the 95% CI was estimated using Blaker’s exact CI, and p-value were estimated from binomial exact method. The statistical criterion for success requires the lower bound of the 2-sided 95% CI for vaccine efficacy to be > 25%.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Binomial Exact Method
    Parameter type
    		 Vaccine Efficiency %
    Point estimate
    72.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 64.329
         upper limit
    		 79.664

    Secondary: Incidence Rate of VCD Cases with Severe Dengue and/or Dengue with Warning Signs

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    End point title
    		 Incidence Rate of VCD Cases with Severe Dengue and/or Dengue with Warning Signs
    End point description
    The incidence rate of VCD cases was defined as the number of VCD cases per 100 person-years at risk. The person-years at risk of each individual participant is the cumulative time (in years) until the participant was diagnosed with first symptomatic VCD episode or until the end of the study for each participant, whichever came first. The incidence rate for any serotype of dengue virus was reported. The analysis population consisted of the randomized participants with warning signs or severe dengue who met the inclusion criteria and did not meet any exclusion criteria, received the investigational product to which they were randomized in accordance with the handling and administration conditions recommended by the manufacturer, did not use restricted medications, as per the protocol, and did not withdraw informed consent.
    End point type
    Secondary
    End point timeframe
    Up to approximately 28 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    10209
    5940
    Units: Cases per 100 Person/Years
        number (confidence interval 95%)
    0.013 (0.005 to 0.028)
    0.065 (0.039 to 0.103)
    Statistical analysis title
    		 Vaccine Efficacy Percentage
    Statistical analysis description
    Vaccine efficacy was estimated based on the exact binomial method proposed by Chan and Bohidar, the 95% CI was estimated using Blaker’s exact CI, and p-value were estimated from binomial exact method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16149
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0019
    Method
    		 Binomial Exact Method
    Parameter type
    		 Vaccine Efficacy Percentage
    Point estimate
    80.511
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 50.828
         upper limit
    		 92.409

    Secondary: Number of Participants Between 2 and 6 Years of Age who Experienced a Solicited ADR

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    End point title
    		 Number of Participants Between 2 and 6 Years of Age who Experienced a Solicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited administration site ADRs included erythema(redness), induration, pain, pruritus, and swelling. Solicited systemic ADRs included arthralgia, chills, eye pain (retro-orbital pain), fatigue (asthenia), headache, myalgia (muscle pain), nausea, photophobia, pruritus, pyrexia (fever), skin rash (exanthema), and vomiting. The number of participants between 2 and 6 years of age who experienced a solicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants from 2 to 6 years of age who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    3337
    1679
    Units: Participants
        Administration Site Erythema
    53
    29
        Administration Site Induration
    55
    39
        Administration Site Pain
    365
    181
        Administration Site Pruritus
    95
    51
        Administration Site Swelling
    30
    17
        Arthralgia
    92
    39
        Chills
    111
    46
        Eye Pain
    119
    43
        Fatigue
    255
    105
        Headache
    622
    259
        Myalgia
    148
    51
        Nausea
    192
    80
        Photophobia
    76
    38
        Pruritus
    438
    85
        Pyrexia
    384
    161
        Skin Rash
    647
    66
        Vomiting
    241
    114
    Statistical analysis title
    		 Dif in %-Administration Site Erythema
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.714
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.6
    Statistical analysis title
    		 Dif in %-Administration Site Induration
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.096
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0.1
    Statistical analysis title
    		 Dif in %-Administration Site Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.866
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 1.9
    Statistical analysis title
    		 Dif in %-Administration Site Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.705
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.8
    Statistical analysis title
    		 Dif in %-Administration Site Swelling
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.694
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.4
    Statistical analysis title
    		 Dif in %-Arthralgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.363
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 1.3
    Statistical analysis title
    		 Dif in %-Chills
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.26
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 1.5
    Statistical analysis title
    		 Dif in %-Eye Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.057
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 2
    Statistical analysis title
    		 Dif in %-Fatigue
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.072
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 2.8
    Statistical analysis title
    		 Dif in %-Photophobia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.975
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.8
    Statistical analysis title
    		 Dif in %-Nausea
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.144
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 2.2
    Statistical analysis title
    		 Dif in %-Myalgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.017
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 2.4
    Statistical analysis title
    		 Dif in %-Headache
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 5.4
    Statistical analysis title
    		 Dif in %-Pyrexia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.039
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 3.7
    Statistical analysis title
    		 Dif in %-Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    8.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.5
         upper limit
    		 9.6
    Statistical analysis title
    		 Dif in %-Skin Rash
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    15.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.8
         upper limit
    		 17.1
    Statistical analysis title
    		 Dif in %-Vomiting
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.573
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.9

    Secondary: Number of Participants Between 2 and 6 Years of Age who Experienced an Unsolicited ADR

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    End point title
    		 Number of Participants Between 2 and 6 Years of Age who Experienced an Unsolicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants between 2 and 6 years of age who experienced an unsolicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants between 2 and 6 years of age who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    3337
    1679
    Units: Participants
    316
    148
    Statistical analysis title
    		 Difference in %-Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.45
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 2.3

    Secondary: Number of Participants Between 7 and 17 Years of Age who Experienced a Solicited ADR

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    End point title
    		 Number of Participants Between 7 and 17 Years of Age who Experienced a Solicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited administration site ADRs included erythema(redness), induration, pain, pruritus, and swelling. Solicited systemic ADRs included arthralgia, chills, eye pain (retro-orbital pain), fatigue (asthenia), headache, myalgia (muscle pain), nausea, photophobia, pruritus, pyrexia (fever), skin rash (exanthema), and vomiting. The number of participants between 7 and 17 years of age who experienced a solicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants between 7 and 17 years of age who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    3376
    1771
    Units: Participants
        Administration Site Erythema
    93
    33
        Administration Site Induration
    50
    22
        Administration Site Pain
    641
    251
        Administration Site Pruritus
    254
    107
        Administration Site Swelling
    44
    19
        Arthralgia
    302
    111
        Chills
    252
    89
        Eye Pain
    654
    225
        Fatigue
    654
    273
        Headache
    1402
    612
        Myalgia
    555
    239
        Nausea
    460
    230
        Photophobia
    389
    173
        Pruritus
    646
    148
        Pyrexia
    362
    131
        Skin Rash
    746
    66
        Vomiting
    199
    84
    Statistical analysis title
    		 Dif in %-Administration Site Erythema
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.049
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1.7
    Statistical analysis title
    		 Dif in %-Administration Site Induration
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.488
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.9
    Statistical analysis title
    		 Dif in %-Administration Site Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 6.9
    Statistical analysis title
    		 Dif in %-Administration Site Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.048
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 2.9
    Statistical analysis title
    		 Dif in %-Administration Site Swelling
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.475
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.8
    Statistical analysis title
    		 Dif in %-Arthralgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 4.1
    Statistical analysis title
    		 Dif in %-Eye Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.6
         upper limit
    		 8.7
    Statistical analysis title
    		 Dif in %-Chills
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 3.8
    Statistical analysis title
    		 Dif in %-Fatigue
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 6.1
    Statistical analysis title
    		 Dif in %-Myalgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 4.9
    Statistical analysis title
    		 Dif in %-Headache
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.2
         upper limit
    		 9.7
    Statistical analysis title
    		 Dif in %-Nausea
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.523
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 2.6
    Statistical analysis title
    		 Dif in %-Photophobia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.055
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 3.5
    Statistical analysis title
    		 Dif in %-Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    10.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.9
         upper limit
    		 12.6
    Statistical analysis title
    		 Dif in %-Skin Rash
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    18.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.7
         upper limit
    		 20
    Statistical analysis title
    		 Dif in %-Pyrexia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 4.9
    Statistical analysis title
    		 Dif in %-Vomiting
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.085
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 2.4

    Secondary: Number of Participants Between 7 and 17 Years of Age who Experienced an Unsolicited ADR

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    End point title
    		 Number of Participants Between 7 and 17 Years of Age who Experienced an Unsolicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants between 7 and 17 years of age who experienced an unsolicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants between 7 and 17 years of age who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    3376
    1771
    Units: Participants
    371
    193
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.92
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 1.8

    Secondary: Number of Participants Between 18 and 59 Years of Age who Experienced a Solicited ADR

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    End point title
    		 Number of Participants Between 18 and 59 Years of Age who Experienced a Solicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited administration site ADRs included erythema(redness), induration, pain, pruritus, and swelling. Solicited systemic ADRs included arthralgia, chills, eye pain (retro-orbital pain), fatigue (asthenia), headache, myalgia (muscle pain), nausea, photophobia, pruritus, pyrexia (fever), skin rash (exanthema), and vomiting. The number of participants between 18 and 59 years of age who experienced a solicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants between 18 and 59 years of age who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    3546
    2526
    Units: Participants
        Administration Site Erythema
    180
    32
        Administration Site Induration
    96
    35
        Administration Site Pain
    530
    240
        Administration Site Pruritus
    238
    86
        Administration Site Swelling
    57
    32
        Arthralgia
    768
    341
        Chills
    521
    200
        Eye Pain
    863
    377
        Fatigue
    1086
    534
        Headache
    1744
    989
        Myalgia
    1113
    476
        Nausea
    605
    324
        Photophobia
    535
    277
        Pruritus
    893
    299
        Pyrexia
    301
    106
        Skin Rash
    933
    121
        Vomiting
    140
    100
    Statistical analysis title
    		 Dif in %-Administration Site Erythema
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3
         upper limit
    		 4.7
    Statistical analysis title
    		 Dif in %-Administration Site Induration
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 2
    Statistical analysis title
    		 Dif in %-Administration Site Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 7.1
    Statistical analysis title
    		 Dif in %-Administration Site Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 4.4
    Statistical analysis title
    		 Dif in %-Administration Site Swelling
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.276
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.9
    Statistical analysis title
    		 Dif in %-Arthralgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    8.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.2
         upper limit
    		 10
    Statistical analysis title
    		 Dif in %-Chills
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.2
         upper limit
    		 8.3
    Statistical analysis title
    		 Dif in %-Eye Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    9.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.4
         upper limit
    		 11.4
    Statistical analysis title
    		 Dif in %-Fatigue
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.3
         upper limit
    		 11.7
    Statistical analysis title
    		 Dif in %-Nausea
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.4
         upper limit
    		 6
    Statistical analysis title
    		 Dif in %-Myalgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    12.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.4
         upper limit
    		 14.7
    Statistical analysis title
    		 Dif in %-Headache
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.5
         upper limit
    		 12.5
    Statistical analysis title
    		 Dif in %-Photophobia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.4
         upper limit
    		 5.8
    Statistical analysis title
    		 Dif in %-Skin Rash
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    21.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.9
         upper limit
    		 23.2
    Statistical analysis title
    		 Dif in %-Pyrexia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 5.5
    Statistical analysis title
    		 Dif in %-Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    13.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.4
         upper limit
    		 15.2
    Statistical analysis title
    		 Dif in %-Vomiting
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.983
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1

    Secondary: Number of Participants Between 18 and 59 Years of Age who Experienced an Unsolicited ADR

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    End point title
    		 Number of Participants Between 18 and 59 Years of Age who Experienced an Unsolicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants between 18 and 59 years of age who experienced an unsolicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants between 18 and 59 years of age who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    3546
    2526
    Units: Participants
    699
    378
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 6.6

    Secondary: Number of Participants with Prior Exposure to Any Serotype of Dengue Virus who Experienced a Solicited ADR

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    End point title
    		 Number of Participants with Prior Exposure to Any Serotype of Dengue Virus who Experienced a Solicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited administration site ADRs included erythema(redness), induration, pain, pruritus, and swelling. Solicited systemic ADRs included arthralgia, chills, eye pain (retro-orbital pain), fatigue (asthenia), headache, myalgia (muscle pain), nausea, photophobia, pruritus, pyrexia (fever), skin rash (exanthema), and vomiting. The number of participants with prior exposure to any serotype of dengue virus who experienced a solicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants with prior exposure to dengue virus who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    5010
    3046
    Units: Participants
        Administration Site Erythema
    118
    47
        Administration Site Induration
    95
    48
        Administration Site Pain
    779
    339
        Administration Site Pruritus
    288
    131
        Administration Site Swelling
    67
    33
        Arthralgia
    608
    299
        Chills
    389
    195
        Eye Pain
    777
    406
        Fatigue
    986
    530
        Headache
    1957
    1088
        Myalgia
    913
    474
        Nausea
    645
    379
        Photophobia
    499
    311
        Pruritus
    858
    296
        Pyrexia
    372
    188
        Skin Rash
    850
    125
        Vomiting
    235
    147
    Statistical analysis title
    		 Dif in %-Administration Site Erythema
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.021
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 1.4
    Statistical analysis title
    		 Dif in %-Administration Site Induration
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.317
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.9
    Statistical analysis title
    		 Dif in %-Administration Site Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 5.5
    Statistical analysis title
    		 Dif in %-Administration Site Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.014
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 2.2
    Statistical analysis title
    		 Dif in %-Administration Site Swelling
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.25
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.8
    Statistical analysis title
    		 Dif in %-Arthralgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 4.4
    Statistical analysis title
    		 Dif in %-Chills
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 2.8
    Statistical analysis title
    		 Dif in %-Eye Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 4
    Statistical analysis title
    		 Dif in %-Fatigue
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 4.6
    Statistical analysis title
    		 Dif in %-Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.2
         upper limit
    		 9.1
    Statistical analysis title
    		 Dif in %-Photophobia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.894
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 1.2
    Statistical analysis title
    		 Dif in %-Headache
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.9
         upper limit
    		 6.2
    Statistical analysis title
    		 Dif in %-Myalgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 5.1
    Statistical analysis title
    		 Dif in %-Nausea
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.414
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 2.1
    Statistical analysis title
    		 Dif in %-Pyrexia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.103
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 2.1
    Statistical analysis title
    		 Dif in %-Skin Rash
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    12.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.5
         upper limit
    		 14.1
    Statistical analysis title
    		 Dif in %-Vomiting
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.54
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.7

    Secondary: Number of Participants with Prior Exposure to Any Serotype of Dengue Virus who Experienced an Unsolicited ADR

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    End point title
    		 Number of Participants with Prior Exposure to Any Serotype of Dengue Virus who Experienced an Unsolicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with prior exposure to any serotype of dengue virus who experienced an unsolicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants with prior exposure to any serotype of dengue virus who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    5010
    3046
    Units: Participants
    667
    401
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.434
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 2.1

    Secondary: Number of Participants Without Prior Exposure to Any Serotype of Dengue Virus who Experienced a Solicited ADR

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    End point title
    		 Number of Participants Without Prior Exposure to Any Serotype of Dengue Virus who Experienced a Solicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited administration site ADRs included erythema(redness), induration, pain, pruritus, and swelling. Solicited systemic ADRs included arthralgia, chills, eye pain (retro-orbital pain), fatigue (asthenia), headache, myalgia (muscle pain), nausea, photophobia, pruritus, pyrexia (fever), skin rash (exanthema), and vomiting. The number of participants without prior exposure to any serotype of dengue virus who experienced a solicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants without prior exposure to dengue virus who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    4843
    2690
    Units: Participants
        Administration Site Erythema
    201
    42
        Administration Site Induration
    99
    42
        Administration Site Pain
    687
    304
        Administration Site Pruritus
    274
    106
        Administration Site Swelling
    57
    32
        Arthralgia
    494
    165
        Chills
    450
    124
        Eye Pain
    782
    207
        Fatigue
    917
    345
        Headache
    1647
    684
        Myalgia
    815
    263
        Nausea
    562
    232
        Photophobia
    449
    152
        Pruritus
    1039
    209
        Pyrexia
    632
    188
        Skin Rash
    1387
    115
        Vomiting
    327
    145
    Statistical analysis title
    		 Dif in %-Administration Site Erythema
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 3.6
    Statistical analysis title
    		 Dif in %-Administration Site Induration
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.119
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 1.1
    Statistical analysis title
    		 Dif in %-Administration Site Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 4.5
    Statistical analysis title
    		 Dif in %-Administration Site Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 2.9
    Statistical analysis title
    		 Dif in %-Administration Site Swelling
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.999
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.5
    Statistical analysis title
    		 Dif in %-Arthralgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 6.2
    Statistical analysis title
    		 Dif in %-Chills
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.1
         upper limit
    		 6.4
    Statistical analysis title
    		 Dif in %-Eye Pain
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8
         upper limit
    		 10.9
    Statistical analysis title
    		 Dif in %-Fatigue
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.7
         upper limit
    		 8.9
    Statistical analysis title
    		 Dif in %-Pruritus
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    14.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.9
         upper limit
    		 16
    Statistical analysis title
    		 Dif in %-Photophobia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 5.5
    Statistical analysis title
    		 Dif in %-Headache
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    10.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.1
         upper limit
    		 12
    Statistical analysis title
    		 Dif in %-Myalgia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    8.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.9
         upper limit
    		 9.8
    Statistical analysis title
    		 Dif in %-Nausea
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.1
         upper limit
    		 4.9
    Statistical analysis title
    		 Dif in %-Pyrexia
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.5
         upper limit
    		 7.2
    Statistical analysis title
    		 Dif in %-Skin Rash
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.5
         upper limit
    		 26.5
    Statistical analysis title
    		 Dif in %-Vomiting
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.035
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 2.3

    Secondary: Number of Participants Without Prior Exposure to Any Serotype of Dengue Virus who Experienced an Unsolicited ADR

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    End point title
    		 Number of Participants Without Prior Exposure to Any Serotype of Dengue Virus who Experienced an Unsolicited ADR
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants without prior exposure to any serotype of dengue virus who experienced an unsolicited ADR within the first 21 days postvaccination was reported. The population analyzed was all randomized participants without prior exposure to any serotype of dengue virus who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 21 days postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    4843
    2690
    Units: Participants
    663
    284
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.1
         upper limit
    		 5.1

    Secondary: Number of Participants who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study

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    End point title
    		 Number of Participants who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an unsolicited ADR from day 22 postvaccination through the duration of the study was reported. The population analyzed was all randomized participants without prior exposure to any serotype of dengue virus who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    10259
    5976
    Units: Participants
    23
    15
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    16235
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.996
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.1

    Secondary: Number of Participants Between 2 and 6 Years of Age who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study

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    End point title
    		 Number of Participants Between 2 and 6 Years of Age who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants from 2 to 6 years of age who experienced an unsolicited ADR from day 22 postvaccination through the duration of the study was reported. The population analyzed was all randomized participants from 2 to 6 years of age without prior exposure to any serotype of dengue virus who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    3337
    1679
    Units: Participants
    3
    0
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.219
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.3

    Secondary: Number of Participants Between 7 and 17 Years of Age who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study

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    End point title
    		 Number of Participants Between 7 and 17 Years of Age who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants from the ages of 7 to 17 years of age who experienced an unsolicited ADR from day 22 postvaccination through the duration of the study was reported. The population analyzed was all randomized participants between 7 and 17 without prior exposure to any serotype of dengue virus who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    3376
    1771
    Units: Participants
    6
    3
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    5147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.946
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.2

    Secondary: Number of Participants Between 18 and 59 Years of Age who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study

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    End point title
    		 Number of Participants Between 18 and 59 Years of Age who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants between 18 and 59 years of age who experienced an unsolicited ADR from day 22 postvaccination through the duration of the study was reported. The population analyzed was all randomized participants between 18 and 59 years of age who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    3546
    2526
    Units: Participants
    14
    12
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    6072
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.637
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.3

    Secondary: Number of Participants With Prior Exposure to Any Serotype of Dengue Virus who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study

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    End point title
    		 Number of Participants With Prior Exposure to Any Serotype of Dengue Virus who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with prior exposure to dengue virus who experienced an unsolicited ADR from day 22 postvaccination through the duration of the study was reported. The population analyzed was all randomized participants with prior exposure to dengue virus without prior exposure to any serotype of dengue virus who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    5010
    3046
    Units: Participants
    9
    5
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    8056
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.838
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.2

    Secondary: Number of Participants Without Prior Exposure to Any Serotype of Dengue Virus who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study

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    End point title
    		 Number of Participants Without Prior Exposure to Any Serotype of Dengue Virus who Experienced an Unsolicited ADR from Day 22 Postvaccination through the Duration of the Study
    End point description
    An ADR was defined as an AE that had a reasonable causal link with the vaccination. An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants without prior exposure to any serotype of dengue virus who experienced an unsolicited ADR from day 22 postvaccination through the duration of the study was reported. The population analyzed was all randomized participants without prior exposure to any serotype of dengue virus, without prior exposure to any serotype of dengue virus who received at least 1 dose of study intervention according to the study intervention they received.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years postvaccination
    End point values
    		 Dengue 1,2,3,4 (Attenuated) Vaccine Placebo
    Number of subjects analysed
    4843
    2690
    Units: Participants
    11
    9
    Statistical analysis title
    		 Difference in Percentage - Unsolicited AEs
    Statistical analysis description
    Estimated differences, CIs, and p-value were calculated based on Miettinen & Nurminen method.
    Comparison groups
    Dengue 1,2,3,4 (Attenuated) Vaccine v Placebo
    Number of subjects included in analysis
    7533
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.625
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 9 years
    Adverse event reporting additional description
    All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single 0.5 mL SC dose of placebo.

    Reporting group title
    Dengue 1,2,3,4 (Attenuated) Vaccine
    Reporting group description
    		 Participants received a single 0.5 mL subcutaneous (SC) dose of dengue 1,2,3,4 (attenuated) vaccine.

    Serious adverse events
    		 Placebo Dengue 1,2,3,4 (Attenuated) Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    459 / 5976 (7.68%)
    756 / 10259 (7.37%)
         number of deaths (all causes)
    34
    43
         number of deaths resulting from adverse events
    34
    43
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of the cervix
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system neoplasm
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign mesothelioma
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign hydatidiform mole
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Astrocytoma malignant
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cervix carcinoma stage 0
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Langerhans' cell histiocytosis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric leiomyoma
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female reproductive neoplasm
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial neoplasm
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian neoplasm
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schwannoma
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine neuroendocrine tumour
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    2 / 5976 (0.03%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    2 / 5976 (0.03%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial rupture
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial thrombosis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombophlebitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superficial vein thrombosis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kawasaki's disease
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    5 / 5976 (0.08%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Haemorrhage in pregnancy
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HELLP syndrome
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gestational hypertension
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gestational diabetes
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion
         subjects affected / exposed
    9 / 5976 (0.15%)
    15 / 10259 (0.15%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anembryonic gestation
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion threatened
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion spontaneous incomplete
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion missed
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    2 / 5976 (0.03%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Threatened labour
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured ectopic pregnancy
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature rupture of membranes
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature delivery
         subjects affected / exposed
    2 / 5976 (0.03%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    5 / 5976 (0.08%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperemesis gravidarum
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion spontaneous*
         subjects affected / exposed
    4 / 5976 (0.07%)
    14 / 10259 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foetal death*
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 5976 (0.05%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 5976 (0.00%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Pyrexia
         subjects affected / exposed
    0 / 5976 (0.00%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ill-defined disorder
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodule
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Allergic oedema
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 5976 (0.00%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Substance abuser
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sexual abuse
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Physical assault
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Victim of homicide
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Testicular torsion
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular infarction
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Priapism
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst torsion
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermenstrual bleeding
         subjects affected / exposed
    7 / 5976 (0.12%)
    5 / 10259 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast pain
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nasal polyps
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    4 / 5976 (0.07%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 5976 (0.02%)
    5 / 10259 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    9 / 5976 (0.15%)
    20 / 10259 (0.19%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    5 / 5976 (0.08%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bipolar disorder
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Depression
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic disorder
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    2 / 5976 (0.03%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somatic symptom disorder
         subjects affected / exposed
    2 / 5976 (0.03%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    4 / 5976 (0.07%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    9 / 5976 (0.15%)
    10 / 10259 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    5 / 5976 (0.08%)
    7 / 10259 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Contusion
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniofacial fracture
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder injury
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    5 / 10259 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Face injury
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hand fracture
         subjects affected / exposed
    3 / 5976 (0.05%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    2 / 5976 (0.03%)
    6 / 10259 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Fracture
         subjects affected / exposed
    4 / 5976 (0.07%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body ingestion
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    3 / 5976 (0.05%)
    5 / 10259 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    3 / 5976 (0.05%)
    6 / 10259 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    2 / 5976 (0.03%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    2 / 5976 (0.03%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    7 / 5976 (0.12%)
    11 / 10259 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunisation reaction
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    3 / 5976 (0.05%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    5 / 5976 (0.08%)
    9 / 10259 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    2 / 5976 (0.03%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Multiple injuries
         subjects affected / exposed
    8 / 5976 (0.13%)
    8 / 10259 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Neck injury
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penetrating abdominal trauma
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin wound
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    3 / 5976 (0.05%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular injury
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    7 / 5976 (0.12%)
    6 / 10259 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    5 / 10259 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    7 / 5976 (0.12%)
    12 / 10259 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    3 / 5976 (0.05%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroschisis*
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syndactyly*
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    6 / 5976 (0.10%)
    15 / 10259 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 17
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Angina pectoris
         subjects affected / exposed
    2 / 5976 (0.03%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Coronary artery disease
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 5976 (0.03%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebellar stroke
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    6 / 5976 (0.10%)
    8 / 10259 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bell's palsy
         subjects affected / exposed
    2 / 5976 (0.03%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    4 / 5976 (0.07%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 5976 (0.00%)
    5 / 10259 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Motor neurone disease
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoplegia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Multiple sclerosis
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 5976 (0.02%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    6 / 5976 (0.10%)
    9 / 10259 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 5976 (0.02%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transverse sinus thrombosis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    5 / 5976 (0.08%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric lymphadenitis
         subjects affected / exposed
    1 / 5976 (0.02%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 5976 (0.07%)
    8 / 10259 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bezoar
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 5976 (0.00%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal hernia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal perforation
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic artery aneurysm
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    3 / 5976 (0.05%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 5976 (0.03%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    3 / 5976 (0.05%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 5976 (0.03%)
    8 / 10259 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis fulminant
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Liver disorder
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Cellulite
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin lesion
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin disorder
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petechiae
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Henoch-Schonlein purpura
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis bullous
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cutaneous vasculitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephritic syndrome
         subjects affected / exposed
    2 / 5976 (0.03%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    11 / 5976 (0.18%)
    13 / 10259 (0.13%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    3 / 5976 (0.05%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anuria
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choluria
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Glomerulonephritis acute
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis proliferative
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post streptococcal glomerulonephritis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    2 / 5976 (0.03%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 5976 (0.03%)
    5 / 10259 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin pain
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    3 / 5976 (0.05%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess of eyelid
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    American trypanosomiasis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess jaw
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    26 / 5976 (0.44%)
    45 / 10259 (0.44%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bartholinitis
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 5976 (0.03%)
    5 / 10259 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    35 / 5976 (0.59%)
    51 / 10259 (0.50%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 52
         deaths causally related to treatment / all
    0 / 6
    0 / 5
    COVID-19 pneumonia
         subjects affected / exposed
    3 / 5976 (0.05%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cellulitis
         subjects affected / exposed
    7 / 5976 (0.12%)
    13 / 10259 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system infection
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chikungunya virus infection
         subjects affected / exposed
    2 / 5976 (0.03%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    14 / 5976 (0.23%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    2 / 15
    0 / 4
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Dermatophytosis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cutaneous larva migrans
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 5976 (0.03%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fallopian tube abscess
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    12 / 5976 (0.20%)
    24 / 10259 (0.23%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIV infection
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 5976 (0.02%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis bacterial
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    4 / 5976 (0.07%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis herpes
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurocysticercosis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oophoritis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 5976 (0.02%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myiasis
         subjects affected / exposed
    1 / 5976 (0.02%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal disease
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    5 / 5976 (0.08%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puerperal infection
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary histoplasmosis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pelvic inflammatory disease
         subjects affected / exposed
    3 / 5976 (0.05%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perichondritis
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal abscess
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 5976 (0.02%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    29 / 5976 (0.49%)
    54 / 10259 (0.53%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 58
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pulmonary sepsis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    7 / 5976 (0.12%)
    20 / 10259 (0.19%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rickettsiosis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 5976 (0.03%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Submandibular abscess
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    5 / 5976 (0.08%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sporotrichosis
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Severe acute respiratory syndrome
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Suspected COVID-19
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular abscess
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 5976 (0.00%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 5976 (0.03%)
    7 / 10259 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    11 / 5976 (0.18%)
    25 / 10259 (0.24%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 5976 (0.12%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 5976 (0.02%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 5976 (0.00%)
    5 / 10259 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 5976 (0.02%)
    4 / 10259 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 5976 (0.02%)
    0 / 10259 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 5976 (0.02%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 5976 (0.02%)
    3 / 10259 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 5976 (0.00%)
    2 / 10259 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 5976 (0.03%)
    1 / 10259 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Dengue 1,2,3,4 (Attenuated) Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3112 / 5976 (52.07%)
    6581 / 10259 (64.15%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1867 / 5976 (31.24%)
    3772 / 10259 (36.77%)
         occurrences all number
    2824
    5793
    General disorders and administration site conditions
    Administration site pruritus
         subjects affected / exposed
    244 / 5976 (4.08%)
    589 / 10259 (5.74%)
         occurrences all number
    271
    657
    Administration site pain
         subjects affected / exposed
    672 / 5976 (11.24%)
    1536 / 10259 (14.97%)
         occurrences all number
    723
    1652
    Chills
         subjects affected / exposed
    336 / 5976 (5.62%)
    886 / 10259 (8.64%)
         occurrences all number
    406
    1005
    Fatigue
         subjects affected / exposed
    914 / 5976 (15.29%)
    1998 / 10259 (19.48%)
         occurrences all number
    1239
    2756
    Pyrexia
         subjects affected / exposed
    700 / 5976 (11.71%)
    1580 / 10259 (15.40%)
         occurrences all number
    783
    1762
    Eye disorders
    Photophobia
         subjects affected / exposed
    488 / 5976 (8.17%)
    1001 / 10259 (9.76%)
         occurrences all number
    648
    1291
    Eye pain
         subjects affected / exposed
    647 / 5976 (10.83%)
    1639 / 10259 (15.98%)
         occurrences all number
    843
    2058
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    637 / 5976 (10.66%)
    1258 / 10259 (12.26%)
         occurrences all number
    782
    1568
    Vomiting
         subjects affected / exposed
    300 / 5976 (5.02%)
    582 / 10259 (5.67%)
         occurrences all number
    330
    655
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    532 / 5976 (8.90%)
    1980 / 10259 (19.30%)
         occurrences all number
    664
    2347
    Rash
         subjects affected / exposed
    254 / 5976 (4.25%)
    2328 / 10259 (22.69%)
         occurrences all number
    274
    2459
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    491 / 5976 (8.22%)
    1165 / 10259 (11.36%)
         occurrences all number
    623
    1501
    Myalgia
         subjects affected / exposed
    768 / 5976 (12.85%)
    1818 / 10259 (17.72%)
         occurrences all number
    1005
    2320

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2017
    The primary purpose of amendment 1 was to update the safety analysis, rationale for placebo use and include exploratory objective with regard to other arbovirus-related conditions.
    08 Apr 2017
    The primary purpose of amendment 2 was to incorporate authorization for use of the vaccine eight hours after reconstitution and update the safety information from the phase II study.
    27 Apr 2018
    The primary purpose of amendment 3 was to modify the subgroup of consistency of immune response to different lots of the vaccine.
    19 Jun 2020
    The primary purpose of amendment 4 was to clarify the time frame for performing unblinded interim analysis, specify type of nonstructural protein 1 analysis, add the possibility of using validated tests similar to the plaque reduction neutralization test and detail the arboviruses for evaluating interactions.
    22 Sep 2021
    The primary purpose of amendment 5 was to modify the immunological evaluation and revise evaluation times and sample size of the subgroup on consistency of immune response to different lots of the vaccine and incorporate a comparison of the conventional formulation and the simplified formulation.
    22 Sep 2021
    The primary purpose of amendment 6 was to make changes according to health agency requirements.
    13 Apr 2022
    The primary purpose of amendment 7 was to detail the center’s actions in the event it is contacted by the participant after the last protocol visit of the trial to report a serious adverse event or fever and adds rapid dengue testing for the inclusion of research participants.
    20 Apr 2023
    The primary purpose amendment 8 was to extend the mandatory contraception period by means of the use of an effective contraceptive method by 90 days post-vaccination and update the text on the estimated participant allocation by strata and study phases.
    17 Apr 2024
    The primary purpose of amendment 9 was to harmonize the objectives and endpoints previously described in the protocol, clarify that the sub-studies: Consistency of immune response to different lots of the vaccine and non-inferiority between the simplified formulation and the conventional formulations are described on Appendix C, and clarify that the mandatory contraception period by means of the use of an effective contraceptive method by 90 days post-vaccination is for the population of the lot consistency substudy.

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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