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    Clinical Trial Results:
    Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old

    Summary
    EudraCT number
    2018-003979-34
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    28 Jun 2024

    Results information
    Results version number
    v2(current)
    This version publication date
    04 Jul 2025
    First version publication date
    12 Mar 2023
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    DEN-301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02747927
    WHO universal trial number (UTN)
    U1111-1166-8401
    Other trial identifiers
    PHRR: PHRR150522-001010
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    40 Landsdowne, Cambridge MA, United States, 02139
    Public contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Scientific contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants. In addition, the efficacy of a TDV booster dose was assessed.
    Protection of trial subjects
    All study participants were required to read and sign an informed consent form. Assent was also obtained from the participant where required.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Sep 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 1774
    Country: Number of subjects enrolled
    Colombia: 3900
    Country: Number of subjects enrolled
    Dominican Republic: 1600
    Country: Number of subjects enrolled
    Nicaragua: 825
    Country: Number of subjects enrolled
    Panama: 3000
    Country: Number of subjects enrolled
    Philippines: 3927
    Country: Number of subjects enrolled
    Sri Lanka: 2100
    Country: Number of subjects enrolled
    Thailand: 2973
    Worldwide total number of subjects
    20099
    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)
    13661
    Adolescents (12-17 years)
    6438
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants took part in the study at various investigative sites globally from 7 September 2016 to 28 June 2024.

    Pre-assignment
    Screening details
    Healthy children and adolescents were randomized in a 2:1 ratio to receive either tetravalent dengue vaccine (TDV) or placebo followed by a booster vaccination. The analysis of data for Part 5 is pending and anticipated reporting date for Part 5 is December 2025.

    Pre-assignment period milestones
    Number of subjects started
    20099
    Number of subjects completed
    20067

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Did Not Receive Even 1 Dose of Trial Vaccine: 32
    Period 1
    Period 1 title
    Part 1: Vaccine Efficacy (Months 0-15)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV placebo-matching, 0.5 ml, SC injection.

    Arm title
    TDV 0.5 mL
    Arm description
    Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Tetravalent Dengue Vaccine (TDV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV 0.5 ml SC injection.

    Number of subjects in period 1 [1]
    Placebo TDV 0.5 mL
    Started
    6687
    13380
    Completed
    6519
    13033
    Not completed
    168
    347
         Adverse event, non-fatal
    5
    14
         Reason Not Specified
    6
    13
         Pregnancy
    19
    42
         Withdrawal by Subject and/or Their Parent/Guardian
    122
    245
         Without Adult Consent in Place
    1
    4
         Lost to follow-up
    13
    26
         Protocol deviation
    2
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The Baseline was collected for Safety Set which included all randomized participants who received at least 1 dose of the trial vaccines (TDV or placebo).
    Period 2
    Period 2 title
    Part 2: Additional VE (Months 16-21)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV placebo-matching, 0.5 ml, SC injection

    Arm title
    TDV 0.5 mL
    Arm description
    Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Tetravalent Dengue Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV 0.5 ml, SC injection

    Number of subjects in period 2
    Placebo TDV 0.5 mL
    Started
    6519
    13033
    Completed
    6487
    12961
    Not completed
    32
    72
         Adverse event, non-fatal
    -
    1
         Reason Not Specified
    3
    6
         Pregnancy
    11
    17
         Withdrawal by Subject and/or Their Parent/Guardian
    13
    33
         Without Adult Consent in Place
    1
    7
         Lost to follow-up
    4
    8
    Period 3
    Period 3 title
    Part 3: Long Term Safety & VE (3 Years)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV placebo-matching, 0.5 ml, SC injection

    Arm title
    TDV 0.5 mL
    Arm description
    Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Tetravalent Dengue Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV 0.5 ml, SC injection

    Number of subjects in period 3
    Placebo TDV 0.5 mL
    Started
    6487
    12961
    Completed
    6080
    12177
    Not completed
    407
    784
         Adverse event, non-fatal
    6
    10
         Reason Not Specified
    13
    18
         Pregnancy
    120
    228
         Withdrawal by Subject and/or Their Parent/Guardian
    119
    227
         Without Adult Consent in Place
    82
    152
         Lost to follow-up
    66
    147
         Protocol deviation
    1
    2
    Period 4
    Period 4 title
    Part 4: Booster VE & Safety (13 Months)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV placebo-matching, 0.5 ml, SC injection

    Arm title
    TDV 0.5 mL
    Arm description
    Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Tetravalent Dengue Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV, 0.5 ml, SC injection

    Number of subjects in period 4 [2]
    Placebo TDV 0.5 mL
    Started
    2985
    5990
    Completed
    2939
    5888
    Not completed
    46
    102
         Adverse event, non-fatal
    1
    3
         Reason Not Specified
    4
    9
         Pregnancy
    8
    15
         Withdrawal by Subject and/or Their Parent/Guardian
    29
    60
         Without Adult Consent in Place
    -
    1
         Lost to follow-up
    4
    14
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only participants from the PPS who were 4 to 11 years of age at the time of randomization in the trial on Day 1 (Month 0) can participate in the booster phase of this trial.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.

    Reporting group title
    TDV 0.5 mL
    Reporting group description
    Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.

    Reporting group values
    Placebo TDV 0.5 mL Total
    Number of subjects
    6687 13380
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    9.6 ( 3.34 ) 9.6 ( 3.36 ) -
    Gender categorical
    Units: Subjects
        Male
    3411 6729 10140
        Female
    3276 6651 9927
    Race
    Units: Subjects
        American Indian or Alaska Native
    2621 5234 7855
        Asian
    2985 5988 8973
        Black or African American
    758 1451 2209
        Native Hawaiian or Other Pacific Islander
    1 2 3
        White
    149 329 478
        More than one race or Unknown
    173 376 549
    Height
    Units: cm
        arithmetic mean (standard deviation)
    135.00 ( 19.027 ) 134.95 ( 19.174 ) -
    Body Mass Index (BMI)
    BMI=weight (kg)/[height (m)^2]
    Units: kg/m^2
        arithmetic mean (standard deviation)
    17.68 ( 3.643 ) 17.78 ( 3.834 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    33.86 ( 14.540 ) 34.05 ( 14.976 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.

    Reporting group title
    TDV 0.5 mL
    Reporting group description
    Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.

    Reporting group title
    TDV 0.5 mL
    Reporting group description
    Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.

    Reporting group title
    TDV 0.5 mL
    Reporting group description
    Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.

    Reporting group title
    TDV 0.5 mL
    Reporting group description
    Participants received TDV, 0.5 ml, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.

    Primary: Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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    End point title
    Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
    End point description
    The Vaccine Efficacy is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of vaccine efficacy was assessed using the number of confirmed dengue cases that occurred during Part 1. Per protocol Set (PPS) included all participants in the Full analysis set (FAS) who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 1 (Month 15) when at least 120 cases of dengue fever were confirmed and minimum duration of participant follow-up was 12 months post-second vaccination
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6316
    12700
    Units: number of cases
    149
    61
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Assuming true VE of 60% and, virologically confirmed cases of dengue fever induced by any dengue serotype occurring from 30 days post 2nd vaccination (Day 120) until end of Part 1 would provide at least 90% power to rule out vaccine effect of ≤25%.
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    19016
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    < 0.001 [2]
    Method
    Cox Proportional Hazard Model
    Parameter type
    Vaccine Efficacy (VE)
    Point estimate
    80.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    73.3
         upper limit
    85.3
    Notes
    [1] - Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 25%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.
    [2] - VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.

    Secondary: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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    End point title
    VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6316
    12700
    Units: number of cases
        number (not applicable)
    66
    13
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    19016
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [3]
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    90.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    82.6
         upper limit
    94.7
    Notes
    [3] - Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 0%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.

    Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype

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    End point title
    VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6316
    12700
    Units: number of cases
    number (not applicable)
        DENV-1
    62
    38
        DENV-2
    80
    8
        DENV-3
    60
    63
        DENV-4
    5
    5
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    19016
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    69.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.8
         upper limit
    79.9
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    19016
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -69.4
         upper limit
    85.8
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    19016
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    48.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    27.2
         upper limit
    64.1
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    19016
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    95.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    89.9
         upper limit
    97.6

    Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline

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    End point title
    VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with seronegative baseline status and with data available for analyses.
    End point type
    Secondary
    End point timeframe
    From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    1726
    3531
    Units: number of cases
        number (not applicable)
    56
    39
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    5257
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    66.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    49.1
         upper limit
    77.5

    Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline

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    End point title
    VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline
    End point description
    VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with seropositive baseline status and with data available for analyses.
    End point type
    Secondary
    End point timeframe
    From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    4589
    9167
    Units: number of cases
        number (not applicable)
    150
    75
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    13756
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    76.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    68.5
         upper limit
    81.9

    Secondary: VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype

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    End point title
    VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6316
    12700
    Units: number of cases
        number (not applicable)
    1
    2
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    19016
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    2.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -977.5
         upper limit
    91.1

    Secondary: Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

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    End point title
    Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
    End point description
    Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. The Safety Set-Immunogenicity Subset included all randomised participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). Subjects analysed is the number of participants with data available for analyses. 'n' indicates the number of participants with data available for analyses for the specified category.
    End point type
    Secondary
    End point timeframe
    Days 1 through 7 after each vaccination
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    1329
    2663
    Units: percentage of participants
    number (not applicable)
        <6Years:After 1 Vaccination:Pain:Mild
    19.5
    21.1
        <6Years:After 1 Vaccination:Pain:Moderate
    1.2
    2.1
        <6 Years:After 1st Vaccination:Pain:Severe
    0.6
    0.3
        <6 Years:After 1st Vaccination:Erythema:Mild
    0.6
    0.6
        <6 Years:After 1st Vaccination:Erythema;Moderate
    0
    0.6
        <6 Years:After 1st Vaccination:Erythema;Severe
    0
    0
        <6 Years:After 1st Vaccination:Swelling;Mild
    0.6
    1.9
        <6 Years:After 1st Vaccination:Swelling;Moderate
    0
    0.9
        <6 Years:After 1st Vaccination:Swelling;Severe
    0
    0
        <6 Years;After 2nd Vaccination;Pain: Mild
    13.3
    18.2
        <6 Years;After 2nd Vaccination;Pain:Moderate
    1.2
    2.5
        <6 Years;After 2nd Vaccination;Pain: Severe
    0
    0
        <6 Years; After 2nd Vaccination;Erythema;Mild
    0
    0.6
        <6 Years;After 2nd Vaccination;Erythema;Moderate
    0
    0
        <6 Years;After 2nd Vaccination;Erythema;Severe
    0
    0
        <6 Years;After 2ndVaccination;Swelling;Mild
    0.6
    0.9
        <6 Years;After 2nd Vaccination;Swelling;Moderate
    0
    0.6
        <6 Years;After 2nd Vaccination;Swelling;Severe
    0
    0
        ≥6 Years;After 1st Vaccination;Pain: Mild
    16.9
    23.4
        ≥6 Years;After 1st Vaccination;Pain:Moderate
    2.2
    3.9
        ≥6 Years;After 1st Vaccination;Pain: Severe
    0.3
    0.7
        ≥6 Years;After 1st Vaccination;Erythema;Mild
    0
    1.0
        ≥6 Years;After 1st Vaccination;Erythema;Moderate
    0
    0
        ≥6 Years;After 1st Vaccination;Erythema;Severe
    0
    0
        ≥6 Years;After 1st Vaccination;Swelling;Mild
    0.4
    1.1
        ≥6 Years;After 1st Vaccination;Swelling;Moderate
    0
    0
        ≥6 Years;After 1st Vaccination;Swelling;Severe
    0
    0
        ≥6 Years;After 2nd Vaccination;Pain;Mild
    10.7
    19.7
        ≥6 Years;After 2nd Vaccination;Pain;Moderate
    1.5
    3.2
        ≥6 Years;After 2nd Vaccination;Pain;Severe
    0.3
    0.6
        ≥6 Years;After 2nd Vaccination;Erythema;Mild
    0.1
    0.9
        ≥6 Years;After 2nd Vaccination;ErythemaModerate
    0
    0
        ≥6 Years;After 2nd Vaccination;Erythema;Severe
    0
    0
        ≥6 Years:After 2nd Vaccination;Swelling;Mild
    0.1
    0.5
        ≥6 Years:After 2nd Vaccination;Swelling;Moderate
    0
    0
        ≥6 Years;After 2nd Vaccination;Swelling;Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset

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    End point title
    Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
    End point description
    Solicited systemic AEs in children(<6 years)are defined as fever,irritability/fussiness, drowsiness&loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥6 years) are defined as fever,headache,asthenia,malaise&myalgia that occurred within 14 days after each vaccination. Participant/legal guardian recorded severity of each AE(except fever)according to diary card instruction as none,mild,moderate,orsevere.Severity grades for fever were derived from recorded body temperature measurements&presented using proposed temperature increments published by Brighton Collaboration.Percentages were rounded off to nearest single decimal place except data points where rounding-up may lead to data misinterpretation.SS-Immunogenicity Subset:all randomised participants in safety/immunogenicity subset who received at least 1 dose of trial vaccines(TDV/placebo).'n':number of participants with data available for analyses for specified category. Y=Years.
    End point type
    Secondary
    End point timeframe
    Days 1 through 14 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    1329
    2663
    Units: percentage of participants
    number (not applicable)
        <6 Years;After 1 Vaccination;Irritability:Mild
    8.3
    7.7
        <6Years;After 1 Vaccination;Irritability:Moderate
    0.6
    0.9
        <6Years;After 1 Vaccination;Irritability:Severe
    0
    0.3
        <6Years;After 1 Vaccination;Drowsiness;Mild
    10.1
    8.3
        <6 Years After 1 Vaccination;Drowsiness;Moderate
    0
    2.2
        <6Years;After 1 Vaccination;Drowsiness;Severe
    0
    0.6
        <6Years;After 1 Vaccination;Loss of Appetite;Mild
    7.1
    12.3
        <6Y;After 1 Vaccination;Loss of Appetite;Moderate
    1.8
    1.2
        <6 Y;After 1 Vaccination;Loss of Appetite;Severe
    0.6
    0.6
        <6 Years;After 1 Vaccination;Fever;38.0-<38.5
    3.1
    3.8
        <6 Years;After 1 Vaccination;Fever:38.5-<39.0
    1.9
    1.9
        <6 Years;After 1 Vaccination;Fever:39.0-<39.5
    1.9
    1.9
        <6 Years;After 1 Vaccination;Fever:39.5-<40.0
    0.6
    0.9
        <6 Years;After 1 Vaccination;Fever:≥40.0
    0
    0
        <6 Years;After 2 Vaccination;Irritability:Mild
    2.1
    5.3
        <6 Y;After 2 Vaccination;Irritability:Moderate
    0
    0.4
        <6 Y;After 2 Vaccination;Irritability:Severe
    0
    0.4
        <6 Years;After 2 Vaccination;Drowsiness;Mild
    4.9
    6.0
        <6 Years;After 2 Vaccination;Drowsiness;Moderate
    0
    1.1
        <6 Years;After 2 Vaccination;Drowsiness;Severe
    0
    0
        <6 Y;After 2 Vaccination;Loss of Appetite;Mild
    4.9
    6.0
        <6Y;After 2 Vaccination;Loss of Appetite;Moderate
    0.7
    1.1
        <6Y;After 2 Vaccination;Loss of Appetite;Severe
    0.7
    0.4
        <6 Years;After 2 Vaccination;Fever;38.0-<38.5
    4.3
    1.3
        <6 Years;After 2 Vaccination;Fever;38.5-<39.0
    1.2
    3.4
        <6 Years;After 2 Vaccination;Fever;39.0-<39.5
    1.2
    1.3
        <6 Years;After 2 Vaccination;Fever;39.5-<40.0
    0
    0.6
        <6 Years;After 2 Vaccination;Fever;40.0-<40.5
    0.6
    0.3
        <6 Years;After 2 Vaccination;Fever; ≥40.5
    0
    0
        ≥6 Years;After 1 Vaccination;Headache:Mild
    17.8
    17.5
        ≥6 Years;After 1 Vaccination;Headache:Moderate
    3.4
    5.3
        ≥6 Years;After 1 Vaccination;Headache:Severe
    1.7
    1.8
        ≥6 Years;After 1 Vaccination;Asthenia: Mild
    8.8
    8.8
        ≥6 Years:After 1 Vaccination;Asthenia:Moderate
    2.8
    2.8
        ≥6 Years;After 1 Vaccination;Asthenia:Severe
    0.5
    0.8
        ≥6 Years;After 1 Vaccination;Malaise:Mild
    11.1
    11.8
        ≥6 Years;After 1 Vaccination;Malaise:Moderate
    2.3
    3.4
        ≥6 Years;After 1 Vaccination;Malaise:Severe
    0.8
    1.0
        ≥6 Years;After 1 Vaccination;Myalgia:Mild
    11.8
    14.1
        ≥6 Years;After 1 Vaccination;Myalgia:Moderate
    1.9
    2.9
        ≥6 Years;After 1 Vaccination;Myalgia:Severe
    0.6
    0.9
        ≥6 Years;After 1 Vaccination;Fever:38.0-<38.5
    2.9
    2.9
        ≥6 Years;After 1 Vaccination;Fever:38.5-<39.0
    1.7
    1.9
        ≥6 Years;After 1 Vaccination;Fever:39.0-<39.5
    1.0
    0.5
        ≥6 Years;After 1 Vaccination;Fever:39.5-<40.0
    0.4
    0.4
        ≥6 Years;After 1 Vaccination;Fever:40.0-<40.5
    0.0908
    0.0454
        ≥6 Years;After 1 Vaccination;Fever:40.5-<41.0
    0.0908
    0
        ≥6 Years; After 1 Vaccination;Fever:>=41.0
    0
    0
        ≥6 Years;After 2 Vaccination;Headache:Mild
    10.2
    10.4
        ≥6 Years;After 2 Vaccination;Headache:Moderate
    2.9
    3.5
        ≥6 Years;After 2 Vaccination;Headache:Severe
    1.1
    1.3
        ≥6 Years;After 2 Vaccination;Asthenia:Mild
    5.6
    6.6
        ≥6 Years;After 2 Vaccination;Asthenia:Moderate
    1.6
    1.9
        ≥6 Years;After 2 Vaccination;Asthenia:Severe
    0.4
    0.7
        ≥6 Years;After 2 Vaccination;Malaise: Mild
    6.8
    8.1
        ≥6 Years;After 2 Vaccination;Malaise:Moderate
    1.8
    1.9
        ≥6 Years;After 2 Vaccination;Malaise:Severe
    0.8
    1.0
        ≥6 Years;After 2 Vaccination;Myalgia:Mild
    7.6
    10.7
        ≥6 Years;After 2 Vaccination;Myalgia:Moderate
    1.3
    2.0
        ≥6 Years;After 2 Vaccination;Myalgia:Severe
    0.4
    0.9
        ≥6 Years;After 2 Vaccination;Fever:38.0-<38.5
    3.3
    2.0
        ≥6 Years;After 2 Vaccination;Fever:38.5-<39.0
    1.2
    1.5
        ≥6 Years;After 2 Vaccination;Fever:39.0-<39.5
    1.1
    0.7
        ≥6 Years;After 2 Vaccination;Fever:39.5-<40.0
    0.4
    0.5
        ≥6 Years;After 2 Vaccination;Fever:40.0-<40.5
    0
    0.0454
        ≥6 Years;After 2 Vaccination;Fever:>=40.5
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset

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    End point title
    Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. The SS-Immunogenicity Subset included all randomised participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). 'n' indicates the number of participants with data available for analysis for the specified category.
    End point type
    Secondary
    End point timeframe
    Days 1 through 28 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    1329
    2663
    Units: percentage of participants
    number (not applicable)
        After First Vaccination (n=1329,2663)
    11.5
    11.1
        After Second Vaccination (n=1301,2606)
    9.2
    9.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2

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    End point title
    Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. The Safety Set (SS) included all randomised participants who received at least one dose of the IP (TDV or placebo).
    End point type
    Secondary
    End point timeframe
    From Day 1 until the end of Parts 1 (Month 15) and 2 (Month 21)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6687
    13380
    Units: percentage of participnats
    number (not applicable)
        Part 1
    3.8
    3.1
        Part 2
    1.2
    1.1
        Part 1 and 2 combined
    4.8
    4.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3

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    End point title
    Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3
    End point description
    AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. The SS included all randomised participants who received at least one dose of the IP (TDV or placebo). '999' indicates that analysis of Fatal SAEs separately by 18 months periods in Part 3 (that is ‘First 18 months’ and ‘Last 18 months’) would be performed along with Part 5 analysis, anticipated posting date December 2025.
    End point type
    Secondary
    End point timeframe
    First and Second half (18 months each) of Part 3 (up to 3 years, beginning at Month 22)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6687
    13380
    Units: percentage of participants
    number (not applicable)
        SAEs Related to Study: First Half of Part 3
    0
    0
        SAEs Related to Study: Second Half of Part 3
    0
    0
        Fatal SAEs: First Half of Part 3
    999
    999
        Fatal SAEs: Second Half of Part 3
    999
    999
    No statistical analyses for this end point

    Secondary: Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset

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    End point title
    Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. Per-Protocol Set for Immunogenicity (PPSI): all participants in Full Analysis Set for Immunogenicity (FASI) who had no major protocol violations. The FASI were based on FAS & included all randomised participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. 'n' indicates the number of participants with data available for analysis at the specified time point.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    1247
    2518
    Units: percentage of participants
    number (not applicable)
        Baseline: DENV-1 (n=1247, 2518)
    65.5
    64.3
        Baseline: DENV-2 (n=1247, 2517)
    70.3
    69.6
        Baseline: DENV-3 (n=1247, 2517)
    63.7
    63.5
        Baseline: DENV-4 (n=1247, 2518)
    63.2
    63.5
        Month 1: DENV-1 (n=1165, 2353)
    65.0
    98.0
        Month 1: DENV-2 (n=1164, 2353)
    70.0
    99.5
        Month 1: DENV-3 (n=1164, 2353)
    64.0
    98.7
        Month 1: DENV-4 (n=1165, 2353)
    62.7
    97.1
        Month 3: DENV-1 (n=1244, 2515)
    66.9
    97.1
        Month 3: DENV-2 (n=1244, 2515)
    71.2
    99.7
        Month 3: DENV-3 (n=1243, 2515)
    63.6
    98.1
        Month 3: DENV-4 (n=1244, 2515)
    63.6
    97.3
        Month 4: DENV-1 (n=1131, 2262)
    67.6
    99.8
        Month 4: DENV-2 (n=1131, 2262)
    71.8
    99.912
        Month 4: DENV-3 (n=1131, 2262)
    65.0
    99.9
        Month 4: DENV-4 (n=1131, 2262)
    65.2
    99.912
        Month 9: DENV-1 (n=1085, 2196)
    67.5
    98.3
        Month 9: DENV-2 (n=1085, 2196)
    73.5
    100.0
        Month 9: DENV-3 (n=1085, 2196)
    65.2
    98.8
        Month 9: DENV-4 (n=1085, 2196)
    65.2
    99.0
        Month 15: DENV-1 (n=1115, 2213)
    67.7
    97.6
        Month 15: DENV-2 (n=1115, 2214)
    70.4
    99.954
        Month 15: DENV-3 (n=1115, 2215)
    64.3
    97.7
        Month 15: DENV-4 (n=1115, 2215)
    66.0
    98.4
        Year 1: DENV-1 (n=943, 1904)
    69.7
    97.0
        Year 1: DENV-2 (n=943, 1904)
    72.0
    99.9
        Year 1: DENV-3 (n=943, 1904)
    67.6
    97.3
        Year 1: DENV-4 (n=943, 1904)
    68.6
    98.3
        Year 2: DENV-1 (n=955, 1922)
    71.5
    95.7
        Year 2: DENV-2 (n=955, 1922)
    73.7
    99.948
        Year 2: DENV-3 (n=955, 1922)
    68.8
    95.5
        Year 2: DENV-4 (n=955, 1922)
    70.7
    98.0
        Year 3: DENV-1 (n=1015, 2027)
    72.5
    94.9
        Year 3: DENV-2 (n=1015, 2027)
    73.6
    99.9
        Year 3: DENV-3 (n=1015, 2027)
    70.2
    95.7
        Year 3: DENV-4 (n=1015, 2027)
    71.1
    96.0
    No statistical analyses for this end point

    Secondary: Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset

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    End point title
    Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent), and four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) and at least trivalent (seropositive for ≥3 dengue serotypes), is derived from the titers of dengue-neutralizing antibodies. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. PPSI: all participants in FASI who had no major protocol violations. The FASI were based on FAS & included all randomised participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number of subjects analysed was variable for each category.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    1247
    2518
    Units: percentage of participants
    number (not applicable)
        Baseline: Monovalent
    5.5
    6.6
        Baseline: Bivalent
    3.8
    2.4
        Baseline: Trivalent
    2.7
    2.9
        Baseline: Tetravalent
    60.4
    60.2
        Baseline: At Least Bivalent
    66.9
    65.5
        Baseline: At Least Trivalent
    63.1
    63.1
        Month 1: Monovalent
    7.4
    0.3
        Month 1: Bivalent
    2.8
    0.6
        Month 1: Trivalent
    3.2
    3.7
        Month 1: Tetravalent
    59.8
    95.2
        Month 1: At Least Bivalent
    65.8
    99.4
        Month 1: At Least Trivalent
    63.0
    98.9
        Month 3: Monovalent
    6.8
    0.4
        Month 3: Bivalent
    3.1
    1.1
        Month 3: Trivalent
    3.1
    3.7
        Month 3: Tetravalent
    60.8
    94.6
        Month 3: At Least Bivalent
    67.0
    99.4
        Month 3: At Least Trivalent
    63.8
    98.3
        Month 4: Monovalent
    6.6
    0
        Month 4: Bivalent
    2.6
    0.088
        Month 4: Trivalent
    2.5
    0.1
        Month 4: Tetravalent
    62.6
    99.7
        Month 4: At Least Bivalent
    67.6
    99.956
        Month 4: At Least Trivalent
    65.1
    99.9
        Month 9: Monovalent
    7.7
    0.091
        Month 9: Bivalent
    3.4
    0.8
        Month 9: Trivalent
    2.0
    2.1
        Month 9: Tetravalent
    62.7
    97.0
        Month 9: At Least Bivalent
    68.1
    99.909
        Month 9: At Least Trivalent
    64.7
    99.1
        Month 15: Monovalent
    3.9
    0.5
        Month 15: Bivalent
    3.6
    1.4
        Month 15: Trivalent
    2.1
    2.2
        Month 15: Tetravalent
    62.8
    96.0
        Month 15: At Least Bivalent
    68.4
    99.5
        Month 15: At Least Trivalent
    64.8
    98.1
        Year 1: Monovalent
    3.5
    0.7
        Year 1: Bivalent
    1.9
    1.5
        Year 1: Trivalent
    2.2
    2.2
        Year 1: Tetravalent
    66.0
    95.5
        Year 1: At Least Bivalent
    70.1
    99.3
        Year 1: At Least Trivalent
    68.2
    97.7
        Year 2: Monovalent
    2.9
    1.1
        Year 2: Bivalent
    2.5
    1.9
        Year 2: Trivalent
    1.8
    3.7
        Year 2: Tetravalent
    67.9
    93.3
        Year 2: At Least Bivalent
    72.1
    98.9
        Year 2: At Least Trivalent
    69.6
    97.0
        Year 3:Monovalent
    2.6
    1.6
        Year 3: Bivalent
    1.9
    2.4
        Year 3:Trivalent
    2.6
    3.7
        Year 3:Tetravalent
    68.4
    92.2
        Year 3:At Least Bivalent
    72.8
    98.3
        Year 3:At Least Trivalent
    70.9
    95.9
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset

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    End point title
    Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
    End point description
    GMTs of neutralizing antibodies were measured via microneutralization test 50% (MNT50). The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. PPSI: all participants in FASI who had no major protocol violations. The FASI were based on FAS & included all randomised participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number of subjects analysed was variable for each category.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    1247
    2518
    Units: titres
    geometric mean (confidence interval 95%)
        Baseline: DENV-1
    128.6 (109.3 to 151.4)
    120.3 (107.3 to 134.8)
        Baseline: DENV-2
    197.4 (167.8 to 232.2)
    186.0 (165.9 to 208.4)
        Baseline: DENV-3
    109.4 (93.8 to 127.6)
    108.7 (97.6 to 121.1)
        Baseline: DENV-4
    80.8 (70.2 to 93.1)
    76.2 (69.2 to 83.9)
        Month 1: DENV-1
    127.5 (107.7 to 150.9)
    1031.5 (944.4 to 1126.6)
        Month 1: DENV-2
    197.2 (166.7 to 233.4)
    6575.7 (6237.2 to 6932.5)
        Month 1: DENV-3
    108.6 (92.8 to 127.1)
    1133.8 (1050.4 to 1223.8)
        Month 1: DENV-4
    77.6 (67.2 to 89.7)
    653.4 (607.0 to 703.4)
        Month 3: DENV-1
    126.3 (107.9 to 148.0)
    828.7 (760.6 to 902.8)
        Month 3: DENV-2
    201.0 (171.3 to 236.0)
    3598.5 (3425.0 to 3780.8)
        Month 3: DENV-3
    103.9 (89.5 to 120.7)
    714.2 (661.1 to 771.6)
        Month 3: DENV-4
    77.8 (67.8 to 89.3)
    463.9 (431.3 to 498.9)
        Month 4: DENV-1
    139.0 (117.6 to 164.3)
    1059.2 (981.6 to 1143.0)
        Month 4: DENV-2
    215.3 (181.7 to 255.0)
    3646.7 (3480.0 to 3821.3)
        Month 4: DENV-3
    114.5 (97.7 to 134.3)
    986.7 (924.5 to 1053.0)
        Month 4: DENV-4
    86.2 (74.5 to 99.8)
    630.0 (593.2 to 668.9)
        Month 9: DENV-1
    130.5 (110.3 to 154.4)
    666.6 (611.8 to 726.2)
        Month 9: DENV-2
    225.7 (190.5 to 267.3)
    2521.0 (2392.4 to 2656.5)
        Month 9: DENV-3
    105.3 (89.9 to 123.3)
    513.0 (474.2 to 555.1)
        Month 9: DENV-4
    84.4 (72.9 to 97.8)
    390.0 (363.6 to 418.4)
        Month 15: DENV-1
    139.2 (117.6 to 164.7)
    584.1 (534.9 to 637.8)
        Month 15: DENV-2
    211.8 (178.5 to 251.3)
    1977.3 (1871.7 to 2088.8)
        Month 15: DENV-3
    97.3 (83.3 to 113.5)
    383.9 (354.0 to 416.3)
        Month 15: DENV-4
    99.9 (86.0 to 116.0)
    408.0 (379.6 to 438.6)
        Year 1: DENV-1
    161.8 (135.0 to 193.9)
    567.8 (516.0 to 624.7)
        Year 1: DENV-2
    183.6 (154.4 to 218.3)
    1123.9 (1054.1 to 1198.3)
        Year 1: DENV-3
    111.3 (94.4 to 131.3)
    377.7 (346.2 to 412.2)
        Year 1: DENV-4
    98.9 (84.8 to 115.2)
    345.0 (319.6 to 372.5)
        Year 2: DENV-1
    205.1 (170.9 to 246.1)
    513.5 (466.2 to 565.6)
        Year 2: DENV-2
    208.1 (175.3 to 246.9)
    896.4 (839.2 to 957.5)
        Year 2: DENV-3
    127.5 (108.2 to 150.2)
    323.3 (295.8 to 353.3)
        Year 2: DENV-4
    110.4 (94.8 to 128.4)
    284.0 (263.1 to 306.5)
        Year 3: DENV-1
    214.9 (180.5 to 255.7)
    485.4 (442.4 to 532.5)
        Year 3: DENV-2
    194.5 (165.3 to 228.8)
    725.8 (680.6 to 774.0)
        Year 3: DENV-3
    140.2 (119.7 to 164.4)
    329.5 (302.7 to 358.7)
        Year 3: DENV-4
    108.5 (93.8 to 125.5)
    244.5 (226.6 to 263.9)
    No statistical analyses for this end point

    Other pre-specified: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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    End point title
    VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases due to virologically-confirmed dengue fever that occurred during the first half of Part 3. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Other pre-specified
    End point timeframe
    First half of Part 3 (18 months beginning at Month 22)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6236
    12510
    Units: number of cases
        number (not applicable)
    228
    252
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    18746
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    47.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    37.1
         upper limit
    56

    Other pre-specified: VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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    End point title
    VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases due to virologically-confirmed dengue fever that occurred during the second half of Part 3. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Other pre-specified
    End point timeframe
    Second half of Part 3 (18 months beginning at Month 40)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6102
    12224
    Units: number of cases
        number (not applicable)
    52
    49
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    18326
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    55.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    34.5
         upper limit
    70

    Other pre-specified: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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    End point title
    VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during the first half of Part 3. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Other pre-specified
    End point timeframe
    First half of Part 3 (18 months beginning at Month 22)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6236
    12510
    Units: number of cases
        number (not applicable)
    43
    24
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    18746
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    73.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    56.3
         upper limit
    83.9

    Other pre-specified: VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype

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    End point title
    VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during the second half of Part 3. PPS included all participants in the FAS who had no major protocol violations. FAS included all randomised participants who received at least 1 dose of the trial vaccines. Subjects analysed is the number of participants with data available for analyses.
    End point type
    Other pre-specified
    End point timeframe
    Second half of Part 3 (18 months beginning at Month 40)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    6102
    12224
    Units: number of cases
        number (not applicable)
    15
    2
    Statistical analysis title
    VE of Two Doses of TDV
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    18326
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    93.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    72.4
         upper limit
    98.6

    Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4

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    End point title
    VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4
    End point description
    The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. The Per-Protocol Set-Booster (PPS-B) included all participants in the FAS-B who had no major protocol violations. The Full Analysis Set-Booster (FAS-B) included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
    End point type
    Other pre-specified
    End point timeframe
    From 30 days post-booster vaccination (Day 30 booster [b] (Month 1b)) until the end of Part 4 (Month 13b)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    2981
    5966
    Units: number of cases
        number (not applicable)
    93
    39
    Statistical analysis title
    VE of a TDV Booster Dose
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    8947
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    79.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    70.1
         upper limit
    85.9

    Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

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    End point title
    VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
    End point type
    Other pre-specified
    End point timeframe
    From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    2981
    5966
    Units: number of cases
    number (not applicable)
        DENV-1
    32
    15
        DENV-2
    31
    9
        DENV-3
    4
    3
        DENV-4
    26
    12
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-1
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    8947
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    76.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.1
         upper limit
    87.4
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-2
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    8947
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    85.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    69.9
         upper limit
    93.2
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-3
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    8947
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -69.7
         upper limit
    91.5
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-4
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    8947
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    77.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.8
         upper limit
    88.5

    Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

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    End point title
    VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Subjects analysed is the number of participants with seronegative baseline status and with data available for analyses.
    End point type
    Other pre-specified
    End point timeframe
    From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    986
    1928
    Units: number of cases
    number (not applicable)
        Any Dengue Serotype
    26
    11
        DENV-1
    14
    4
        DENV-2
    5
    1
        DENV-3
    2
    2
        DENV-4
    5
    4
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    Any serotype
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    2914
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    79.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.8
         upper limit
    89.7
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-1
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    2914
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.6
         upper limit
    95.4
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-2
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    2914
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    89.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.5
         upper limit
    98.8
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-3
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    2914
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    42.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -307.5
         upper limit
    92
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-4
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    2914
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -45.1
         upper limit
    89.5

    Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

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    End point title
    VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
    End point description
    VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Subjects analysed is the number of participants with seropositive baseline status and with data available for analyses.
    End point type
    Other pre-specified
    End point timeframe
    From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    1995
    4036
    Units: number of cases
    number (not applicable)
        Any Dengue Serotype
    67
    28
        DENV-1
    18
    11
        DENV-2
    26
    8
        DENV-3
    2
    1
        DENV-4
    21
    8
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    Any serotype
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    6031
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    79.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    68.3
         upper limit
    86.9
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-1
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    6031
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    69.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    36.3
         upper limit
    85.8
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-2
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    6031
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    84.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    66.6
         upper limit
    93.2
    Statistical analysis title
    VE of a TDV Booster Dose
    Statistical analysis description
    DENV-3
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    6031
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    75.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -168.8
         upper limit
    97.8
    Statistical analysis title
    VE of a TDV Booster Dose
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    6031
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    57.2
         upper limit
    91.6

    Other pre-specified: VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

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    End point title
    VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
    End point type
    Other pre-specified
    End point timeframe
    From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    2981
    5966
    Units: number of cases
        number (not applicable)
    24
    3
    Statistical analysis title
    VE of a TDV Booster Dose
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    8947
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    93.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    79.3
         upper limit
    98.1

    Other pre-specified: VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4

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    End point title
    VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
    End point description
    VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever. The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
    End point type
    Other pre-specified
    End point timeframe
    From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    2981
    5966
    Units: number of cases
        number (not applicable)
    1
    0
    Statistical analysis title
    VE of a TDV Booster Dose
    Comparison groups
    Placebo v TDV 0.5 mL
    Number of subjects included in analysis
    8947
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Cox Proportional Hazard Model
    Parameter type
    VE
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -999
         upper limit
    999

    Other pre-specified: Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

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    End point title
    Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
    End point description
    Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place. Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset. Subjects analysed is the number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Other pre-specified
    End point timeframe
    Days 1b through 7b after booster vaccination in Part 4
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    595
    1182
    Units: percentage of participants
    number (not applicable)
        Pain: Mild
    12.1
    20.1
        Pain: Moderate
    3.9
    4.6
        Pain: Severe
    0.7
    1.2
        Erythema: Mild
    0.2
    1.6
        Erythema: Moderate
    0
    0
        Erythema: Severe
    0
    0
        Swelling: Mild
    0.5
    1.0
        Swelling: Moderate
    0
    0
        Swelling: Severe
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4

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    End point title
    Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
    End point description
    Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. Participant/legal guardian recorded the severity of each AE (except fever) according to diary card instruction as none, mild, moderate, or severe. Severity grades for fever were derived from recorded body temperature measurements and presented using proposed temperature increments published by the Brighton Collaboration. Percentages were rounded off to nearest single decimal place except data point where rounding-up may lead to data misinterpretation. Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received booster dose of trial vaccine (TDV or placebo) in the safety subset. Subjects analysed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Other pre-specified
    End point timeframe
    Days 1b through 14b after booster vaccination in Part 4
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    594
    1184
    Units: percentage of participants
    number (not applicable)
        Headache: Mild
    8.6
    12.3
        Headache: Moderate
    4.7
    3.7
        Headache: Severe
    0.5
    1.1
        Asthenia: Mild
    7.1
    7.2
        Asthenia: Moderate
    1.9
    2.4
        Asthenia: Severe
    0.3
    0.7
        Malaise: Mild
    7.6
    8.6
        Malaise: Moderate
    2.0
    2.6
        Malaise: Severe
    0.5
    0.7
        Myalgia: Mild
    9.9
    11.7
        Myalgia: Moderate
    1.5
    3.6
        Myalgia: Severe
    1.0
    0.8
        Fever: 38.0-<38.5
    1.0
    1.8
        Fever: 38.5-<39.0
    0.5
    1.0
        Fever: 39.0-<39.5
    0.2
    0.2
        Fever: 39.5-<40.0
    0
    0.3
        Fever: 40.0-<40.5
    0.2
    0
        Fever: 40.5-<41.0
    0
    0.0873
        Fever: >=41.0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4

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    End point title
    Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Percentages were rounded off to the nearest single decimal place. Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomisation in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset.
    End point type
    Other pre-specified
    End point timeframe
    Days 1b through 28b after booster vaccination in Part 4
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    600
    1200
    Units: percentage of participants
        number (not applicable)
    1.8
    1.9
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants With Serious Adverse Events (SAEs) During Part 4

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    End point title
    Percentage of Participants With Serious Adverse Events (SAEs) During Part 4
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. Safety Set-Booster (SS-B) included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
    End point type
    Other pre-specified
    End point timeframe
    From Day 1b until the end of Part 4 (Month 13b)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    2985
    5990
    Units: percentage of participants
        number (not applicable)
    4.2
    2.7
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Part 4

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    End point title
    Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Part 4
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. SS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 [Month 0]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
    End point type
    Other pre-specified
    End point timeframe
    From Day 1b until the end of Part 4 (Month 13b)
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    2985
    5990
    Units: percentage of participants
    number (not applicable)
        Fatal SAEs
    0.0335
    0.0501
        SAEs Related to Study Drug
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Seropositivity Rate for Each of the 4 Dengue Serotypes During Part 4

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    End point title
    Seropositivity Rate for Each of the 4 Dengue Serotypes During Part 4
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. Per-Protocol Set for Immunogenicity-Booster (PPSI-B):all participants in Full Analysis Set for Immunogenicity-Booster (FASI-B) who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Number of subjects analysed was variable for each category.
    End point type
    Other pre-specified
    End point timeframe
    Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) in Part 4
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    597
    1186
    Units: percentage of participants
    number (not applicable)
        Day 1b: DENV-1
    70.2
    94.4
        Day 1b: DENV-2
    72.5
    99.2
        Day 1b: DENV-3
    69.0
    97.0
        Day 1b: DENV-4
    67.0
    93.4
        Month 1b: DENV-1
    71.6
    99.907
        Month 1b: DENV-2
    74.5
    99.907
        Month 1b: DENV-3
    72.9
    100.0
        Month 1b: DENV-4
    69.2
    99.7
        Month 6b: DENV-1
    72.8
    99.7
        Month 6b: DENV-2
    75.8
    99.8
        Month 6b: DENV-3
    73.0
    99.6
        Month 6b: DENV-4
    70.3
    99.7
        Month 13b: DENV-1
    74.5
    99.911
        Month 13b: DENV-2
    77.4
    99.5
        Month 13b: DENV-3
    74.9
    100.0
        Month 13b: DENV-4
    72.4
    99.8
    No statistical analyses for this end point

    Other pre-specified: Seropositivity Rate for Multiple Dengue Serotypes During Part 4

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    End point title
    Seropositivity Rate for Multiple Dengue Serotypes During Part 4
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent),& four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) & at least trivalent (seropositive for ≥3 dengue serotypes), is derived from titers of dengue-neutralizing antibodies. Seropositive response: reciprocal neutralizing titer ≥ 10. Four DENV serotypes are DENV-1, DENV-2, DENV-3 & DENV-4. Percentages were rounded off to nearest single decimal place except data points where rounding-up may lead to data misinterpretation. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Number of subjects analysed was variable for each category.
    End point type
    Other pre-specified
    End point timeframe
    Pre-booster vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) in Part 4 in Part 4
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    597
    1186
    Units: percentage of participants
    number (not applicable)
        Day 1b: Monovalent
    5.7
    1.3
        Day 1b: Bivalent
    2.0
    3.7
        Day 1b: Trivalent
    2.3
    4.6
        Day 1b: Tetravalent
    65.5
    90.4
        Day 1b: At Least Bivalent
    69.8
    98.7
        Day 1b: At Least Trivalent
    67.8
    95.0
        Month 1b: Monovalent
    6.6
    0
        Month 1b: Bivalent
    2.0
    0
        Month 1b: Trivalent
    3.7
    0.5
        Month 1b: Tetravalent
    66.6
    99.5
        Month 1b:At Least Bivalent
    72.3
    100.0
        Month 1b:At Least Trivalent
    70.3
    100.0
        Month 6b:Monovalent
    6.8
    0.0887
        Month 6b: Bivalent
    2.5
    0.0887
        Month 6b: Trivalent
    3.2
    0.6
        Month 6b: Tetravalent
    67.6
    99.2
        Month 6b:At Least Bivalent
    73.3
    99.911
        Month 6b:At Least Trivalent
    70.8
    99.8
        Month 13b: Monovalent
    6.6
    0
        Month 13b: Bivalent
    2.1
    0
        Month 13b: Trivalent
    2.7
    0.8
        Month 13b: Tetravalent
    70.1
    99.2
        Month 13b: At Least Bivalent
    74.9
    100.0
        Month 13b: At Least Trivalent
    72.7
    100.0
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Part 4

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    End point title
    Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Part 4
    End point description
    GMTs of neutralizing antibodies were measured via MNT50. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Number of subjects analysed was variable for each category.
    End point type
    Other pre-specified
    End point timeframe
    Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) in Part 4
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    597
    1186
    Units: titres
    geometric mean (confidence interval 95%)
        Day 1b: DENV-1
    172.7 (137.8 to 216.5)
    374.7 (332.7 to 422.1)
        Day 1b: DENV-2
    164.5 (133.2 to 203.2)
    609.4 (558.6 to 664.7)
        Day 1b: DENV-3
    129.4 (105.0 to 159.4)
    305.2 (274.6 to 339.3)
        Day 1b: DENV-4
    81.5 (67.8 to 98.1)
    172.9 (156.1 to 191.4)
        Month 1b: DENV-1
    179.8 (142.4 to 227.0)
    1493.8 (1383.2 to 1613.3)
        Month 1b: DENV-2
    174.8 (140.5 to 217.6)
    1611.5 (1492.1 to 1740.4)
        Month 1b: DENV-3
    159.9 (128.4 to 199.0)
    1546.6 (1450.0 to 1649.6)
        Month 1b: DENV-4
    87.3 (72.0 to 105.9)
    793.8 (742.5 to 848.7)
        Month 6b: DENV-1
    191.5 (152.2 to 241.0)
    1000.9 (916.8 to 1092.7)
        Month 6b: DENV-2
    208.0 (167.6 to 258.0)
    1167.2 (1080.8 to 1260.5)
        Month 6b: DENV-3
    156.0 (126.1 to 192.9)
    851.0 (788.9 to 917.9)
        Month 6b: DENV-4
    86.4 (71.9 to 103.9)
    457.6 (427.4 to 490.0)
        Month 13b: DENV-1
    259.3 (204.8 to 328.4)
    949.1 (862.2 to 1044.7)
        Month 13b: DENV-2
    248.9 (199.4 to 310.6)
    1003.2 (920.1 to 1093.9)
        Month 13b: DENV-3
    199.1 (159.9 to 248.0)
    804.1 (739.2 to 874.8)
        Month 13b: DENV-4
    115.0 (94.4 to 140.0)
    433.1 (401.2 to 467.6)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype

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    End point title
    Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype
    End point description
    The GMR is the geometric mean of the ratio of the two visits being compared. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Other pre-specified
    End point timeframe
    Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 30b (Month 1b) in Part 4
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    396
    1067
    Units: unitless ratio
    geometric mean (confidence interval 95%)
        DENV-1
    0.9 (0.8 to 1.0)
    3.1 (2.8 to 3.4)
        DENV-2
    0.9 (0.9 to 1.0)
    2.4 (2.3 to 2.6)
        DENV-3
    1.1 (1.0 to 1.2)
    4.3 (3.9 to 4.7)
        DENV-4
    0.9 (0.9 to 1.0)
    3.5 (3.2 to 3.9)
    No statistical analyses for this end point

    Other pre-specified: GMR of Neutralizing Antibodies for Each Dengue Serotype

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    End point title
    GMR of Neutralizing Antibodies for Each Dengue Serotype
    End point description
    The GMR is the geometric mean of the ratio of the two visits being compared. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Subjects analysed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Other pre-specified
    End point timeframe
    Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 180b (Month 6b) in Part 4
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    408
    1120
    Units: unitless ratio
    geometric mean (confidence interval 95%)
        DENV-1
    1.0 (0.9 to 1.1)
    2.2 (2.0 to 2.4)
        DENV-2
    1.1 (1.0 to 1.3)
    1.8 (1.7 to 2.0)
        DENV-3
    1.0 (0.9 to 1.1)
    2.5 (2.3 to 2.7)
        DENV-4
    0.9 (0.8 to 1.0)
    2.1 (2.0 to 2.3)
    No statistical analyses for this end point

    Other pre-specified: GMR of Neutralizing Antibodies for Each Dengue Serotype

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    End point title
    GMR of Neutralizing Antibodies for Each Dengue Serotype
    End point description
    The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset & for whom there is valid pre-booster measurement & at least 1 valid post-booster measurement for immunogenicity assessments. Subjects analysed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Other pre-specified
    End point timeframe
    Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 395b (Month 13b) in Part 4
    End point values
    Placebo TDV 0.5 mL
    Number of subjects analysed
    408
    1114
    Units: unitless ratio
    geometric mean (confidence interval 95%)
        DENV-1
    1.3 (1.1 to 1.5)
    2.1 (1.9 to 2.3)
        DENV-2
    1.3 (1.1 to 1.5)
    1.6 (1.5 to 1.7)
        DENV-3
    1.3 (1.1 to 1.5)
    2.4 (2.2 to 2.6)
        DENV-4
    1.3 (1.1 to 1.4)
    2.0 (1.9 to 2.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Deaths&SAEs:Parts1+2:Day1 to end of Part2(approx.21 months);Part3:approx.3years; Part4:from booster vaccination(Day1b)until end of Part4[approx.13 months];Other AEs:Part1:up to 28 days post 1st/2nd vaccination;Part4:up to 28 days post booster vaccination.
    Adverse event reporting additional description
    As pre-specified in protocol, AEs are reported separately for Placebo & TDV arms of each Part. For Parts 1-3: Safety Set; For Part 4-5: Safety Set-Booster. Analysis of data for Part 5 is pending & anticipated reporting date for Part 5 is December 2025. Other (Non-serious) AEs:not collected for Parts 2 and 3 as no vaccination was received.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Placebo (Part 1)
    Reporting group description
    Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.

    Reporting group title
    Placebo (Part 2)
    Reporting group description
    Participants went through extended follow-up period for six months up to Month 21 in Part 2 of the study.

    Reporting group title
    TDV (Part 4)
    Reporting group description
    Participants eligible for Booster Phase received TDV, SC injection, based on the randomization on Day 1 (Month 0) in Part 4 of the study.

    Reporting group title
    Placebo (Part 3)
    Reporting group description
    Participants went through long-term follow-up (3 years) to evaluate the safety.

    Reporting group title
    TDV (Part 3)
    Reporting group description
    Participants went through long-term follow-up (3 years) to evaluate the safety.

    Reporting group title
    Placebo (Part 4)
    Reporting group description
    Participants eligible for Booster Phase received placebo matching TDV, SC injection, based on the randomization on Day 1 (Month 0) in Part 4 of the study.

    Reporting group title
    TDV (Part 1)
    Reporting group description
    Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.

    Reporting group title
    TDV (Part 2)
    Reporting group description
    Participants went through extended follow-up period for six months up to Month 21 in Part 2 of the study.

    Serious adverse events
    Placebo (Part 1) Placebo (Part 2) TDV (Part 4) Placebo (Part 3) TDV (Part 3) Placebo (Part 4) TDV (Part 1) TDV (Part 2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    256 / 6687 (3.83%)
    82 / 6519 (1.26%)
    161 / 5990 (2.69%)
    397 / 6487 (6.12%)
    666 / 12961 (5.14%)
    126 / 2985 (4.22%)
    414 / 13380 (3.09%)
    152 / 13033 (1.17%)
         number of deaths (all causes)
    8
    7
    6
    7
    17
    1
    22
    18
         number of deaths resulting from adverse events
    1
    0
    3
    6
    11
    1
    4
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Alveolar rhabdomyosarcoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign hydatidiform mole
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Desmoplastic small round cell tumour
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cutaneous T-cell lymphoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carcinoma in situ
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ependymoma malignant
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammatory myofibroblastic tumour
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medulloblastoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondroma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian germ cell endodermal sinus tumour stage IV
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schwannoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulcerated haemangioma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Behcet's syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kawasaki's disease
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyarteritis nodosa
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subgaleal haematoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion missed
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion incomplete
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion complete
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    1 / 5990 (0.02%)
    7 / 6487 (0.11%)
    6 / 12961 (0.05%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 7
    0 / 6
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion threatened
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anembryonic gestation
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous incomplete
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cephalo-pelvic disproportion
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eclampsia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    False labour
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational hypertension
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    High risk pregnancy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperemesis gravidarum
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labour complication
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placental insufficiency
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyhydramnios
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    4 / 6487 (0.06%)
    9 / 12961 (0.07%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 9
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature delivery
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    3 / 6487 (0.05%)
    8 / 12961 (0.06%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 4
    0 / 8
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stillbirth
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ruptured ectopic pregnancy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature separation of placenta
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature rupture of membranes
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    3 / 6487 (0.05%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Unstable foetal lie
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic delivery
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Threatened labour
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hanging
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Organ failure
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    1 / 2985 (0.03%)
    5 / 13380 (0.04%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Serositis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    2 / 6687 (0.03%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type I hypersensitivity
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Physical assault
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    High risk sexual behaviour
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sexual abuse
         subjects affected / exposed
    3 / 6687 (0.04%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    4 / 13033 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance use
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Victim of sexual abuse
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Victim of crime
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Abnormal uterine bleeding
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Balanoposthitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penile adhesion
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrotal pain
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulval haematoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular torsion
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    3 / 12961 (0.02%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 6687 (0.03%)
    1 / 6519 (0.02%)
    3 / 5990 (0.05%)
    2 / 6487 (0.03%)
    5 / 12961 (0.04%)
    0 / 2985 (0.00%)
    7 / 13380 (0.05%)
    7 / 13033 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 2
    0 / 5
    0 / 0
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    3 / 6687 (0.04%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus pleurisy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus polyp
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aggression
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adjustment disorder
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Antisocial behaviour
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    4 / 12961 (0.03%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Behaviour disorder
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    2 / 6487 (0.03%)
    7 / 12961 (0.05%)
    2 / 2985 (0.07%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 8
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disruptive mood dysregulation disorder
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric symptom
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oppositional defiant disorder
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance use disorder
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    5 / 6487 (0.08%)
    5 / 12961 (0.04%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 7
    0 / 6
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device extrusion
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis sclerosing
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatosplenomegaly
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic dysfunction-associated steatohepatitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Portal hypertension
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    False positive investigation result
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident at work
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    4 / 12961 (0.03%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental exposure to product by child
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    4 / 6687 (0.06%)
    1 / 6519 (0.02%)
    2 / 5990 (0.03%)
    3 / 6487 (0.05%)
    10 / 12961 (0.08%)
    0 / 2985 (0.00%)
    8 / 13380 (0.06%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 3
    0 / 10
    0 / 0
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropod sting
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Avulsion fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blindness traumatic
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    3 / 12961 (0.02%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chemical burn of oral cavity
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniofacial fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electric injury
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrical burn
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electric shock
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epidural haemorrhage
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiphyseal injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exposure to communicable disease
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eyelid injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    4 / 12961 (0.03%)
    3 / 2985 (0.10%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 4
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 3
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured coccyx
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    2 / 6687 (0.03%)
    1 / 6519 (0.02%)
    3 / 5990 (0.05%)
    2 / 6487 (0.03%)
    9 / 12961 (0.07%)
    4 / 2985 (0.13%)
    8 / 13380 (0.06%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 2
    0 / 9
    0 / 4
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    3 / 6487 (0.05%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    3 / 6487 (0.05%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 3
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 6687 (0.01%)
    2 / 6519 (0.03%)
    0 / 5990 (0.00%)
    3 / 6487 (0.05%)
    5 / 12961 (0.04%)
    1 / 2985 (0.03%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 3
    0 / 5
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic rupture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    3 / 6687 (0.04%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    3 / 12961 (0.02%)
    1 / 2985 (0.03%)
    4 / 13380 (0.03%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    3 / 6687 (0.04%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    7 / 12961 (0.05%)
    1 / 2985 (0.03%)
    10 / 13380 (0.07%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
    0 / 7
    0 / 1
    0 / 10
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    2 / 2985 (0.07%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    1 / 2985 (0.03%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    4 / 12961 (0.03%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    3 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 4
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lip injury
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    4 / 12961 (0.03%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 4
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver contusion
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    4 / 12961 (0.03%)
    1 / 2985 (0.03%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 4
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle injury
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open globe injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penetrating abdominal trauma
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perineal injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural discharge
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative adhesion
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shunt malfunction
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    3 / 5990 (0.05%)
    2 / 6487 (0.03%)
    9 / 12961 (0.07%)
    3 / 2985 (0.10%)
    8 / 13380 (0.06%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 2
    0 / 9
    0 / 3
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Rib fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    7 / 6687 (0.10%)
    1 / 6519 (0.02%)
    3 / 5990 (0.05%)
    2 / 6487 (0.03%)
    12 / 12961 (0.09%)
    1 / 2985 (0.03%)
    3 / 13380 (0.02%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 3
    0 / 2
    0 / 12
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin injury
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Snake bite
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury thoracic
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sports injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    2 / 6687 (0.03%)
    1 / 6519 (0.02%)
    4 / 5990 (0.07%)
    2 / 6487 (0.03%)
    5 / 12961 (0.04%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
    0 / 2
    0 / 5
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth fracture
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic liver injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic lung injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venom poisoning
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arteriovenous malformation
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular arteriovenous malformation
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cerebral arteriovenous malformation haemorrhagic
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial septal defect
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital cystic kidney disease
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cryptorchism
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular dystrophy
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Familial periodic paralysis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermoid cyst
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thalassaemia alpha
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatic heart disease
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Bell's palsy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aqueductal stenosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute disseminated encephalomyelitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain hypoxia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral venous thrombosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diplegia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    1 / 2985 (0.03%)
    4 / 13380 (0.03%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic generalised epilepsy
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic headache
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychogenic seizure
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Quadriparesis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Simple partial seizures
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Serotonin syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status migrainosus
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    2 / 5990 (0.03%)
    2 / 6487 (0.03%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 2
    0 / 3
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia of pregnancy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric lymphadenitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    4 / 12961 (0.03%)
    0 / 2985 (0.00%)
    5 / 13380 (0.04%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    2 / 6487 (0.03%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenic purpura
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Corneal opacity
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amaurosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myopia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orbital myositis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Refraction disorder
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    1 / 5990 (0.02%)
    3 / 6487 (0.05%)
    4 / 12961 (0.03%)
    2 / 2985 (0.07%)
    3 / 13380 (0.02%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 3
    0 / 4
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 6687 (0.03%)
    1 / 6519 (0.02%)
    1 / 5990 (0.02%)
    3 / 6487 (0.05%)
    5 / 12961 (0.04%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 3
    0 / 5
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aphthous ulcer
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acid peptic disease
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    3 / 6687 (0.04%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 6687 (0.01%)
    3 / 6519 (0.05%)
    0 / 5990 (0.00%)
    3 / 6487 (0.05%)
    6 / 12961 (0.05%)
    0 / 2985 (0.00%)
    6 / 13380 (0.04%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 3
    0 / 6
    0 / 0
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoid hyperplasia of intestine
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric cyst
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperkeratosis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Henoch-Schonlein purpura
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erythema annulare
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lichen planus
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    4 / 13380 (0.03%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis acute
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis proliferative
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis chronic
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis rapidly progressive
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive nephropathy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    IgA nephropathy
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephritic syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post infection glomerulonephritis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post streptococcal glomerulonephritis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    5 / 13380 (0.04%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelocaliectasis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral caruncle
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder rupture
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Cushing's syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiphysiolysis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exostosis of jaw
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extremity contracture
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Greater trochanteric pain syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle fatigue
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Knee deformity
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Juvenile idiopathic arthritis
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatic fever
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abortion infected
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess jaw
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    7 / 12961 (0.05%)
    0 / 2985 (0.00%)
    5 / 13380 (0.04%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 7
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess of external ear
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess soft tissue
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acarodermatitis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amniotic cavity infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 6687 (0.01%)
    2 / 6519 (0.03%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    6 / 12961 (0.05%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 6
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendiceal abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    14 / 6687 (0.21%)
    6 / 6519 (0.09%)
    7 / 5990 (0.12%)
    27 / 6487 (0.42%)
    60 / 12961 (0.46%)
    5 / 2985 (0.17%)
    30 / 13380 (0.22%)
    14 / 13033 (0.11%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 6
    0 / 7
    0 / 27
    0 / 60
    0 / 5
    0 / 30
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    3 / 5990 (0.05%)
    6 / 6487 (0.09%)
    7 / 12961 (0.05%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    3 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 6
    0 / 7
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arboviral infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascariasis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial vaginosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteriuria
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bartholin's abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cellulitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    4 / 13380 (0.03%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bullous impetigo
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burkholderia pseudomallei infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burn infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    65 / 5990 (1.09%)
    24 / 6487 (0.37%)
    69 / 12961 (0.53%)
    39 / 2985 (1.31%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 68
    0 / 24
    0 / 69
    0 / 40
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    3 / 6487 (0.05%)
    7 / 12961 (0.05%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 7
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    3 / 5990 (0.05%)
    7 / 6487 (0.11%)
    15 / 12961 (0.12%)
    2 / 2985 (0.07%)
    10 / 13380 (0.07%)
    3 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 9
    0 / 15
    0 / 2
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis orbital
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholera
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chikungunya virus infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    2 / 5990 (0.03%)
    7 / 6487 (0.11%)
    12 / 12961 (0.09%)
    4 / 2985 (0.13%)
    6 / 13380 (0.04%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 7
    0 / 12
    0 / 4
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue haemorrhagic fever
         subjects affected / exposed
    19 / 6687 (0.28%)
    6 / 6519 (0.09%)
    0 / 5990 (0.00%)
    12 / 6487 (0.18%)
    9 / 12961 (0.07%)
    4 / 2985 (0.13%)
    4 / 13380 (0.03%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    1 / 19
    0 / 6
    0 / 0
    0 / 12
    0 / 10
    0 / 4
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    52 / 6687 (0.78%)
    10 / 6519 (0.15%)
    7 / 5990 (0.12%)
    83 / 6487 (1.28%)
    56 / 12961 (0.43%)
    32 / 2985 (1.07%)
    13 / 13380 (0.10%)
    9 / 13033 (0.07%)
         occurrences causally related to treatment / all
    1 / 52
    0 / 10
    0 / 7
    0 / 83
    0 / 56
    0 / 32
    1 / 13
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis infected
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erythema infectiosum
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extradural abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye infection gonococcal
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Focal peritonitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis viral
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    8 / 6687 (0.12%)
    2 / 6519 (0.03%)
    1 / 5990 (0.02%)
    11 / 6487 (0.17%)
    18 / 12961 (0.14%)
    2 / 2985 (0.07%)
    29 / 13380 (0.22%)
    7 / 13033 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
    0 / 1
    0 / 11
    0 / 18
    0 / 2
    0 / 29
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal bacterial infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Giardiasis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex encephalitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis viral
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective myositis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of asthma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    7 / 6687 (0.10%)
    5 / 6519 (0.08%)
    0 / 5990 (0.00%)
    9 / 6487 (0.14%)
    12 / 12961 (0.09%)
    1 / 2985 (0.03%)
    14 / 13380 (0.10%)
    6 / 13033 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    0 / 0
    0 / 9
    0 / 12
    0 / 1
    0 / 14
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ludwig angina
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 6687 (0.04%)
    1 / 6519 (0.02%)
    1 / 5990 (0.02%)
    3 / 6487 (0.05%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    10 / 13380 (0.07%)
    3 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 3
    0 / 3
    0 / 0
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leptospirosis
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymph gland infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymph node tuberculosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis bacterial
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    3 / 6687 (0.04%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstetric infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paranasal sinus abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parasite allergy
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parasitic gastroenteritis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic inflammatory disease
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal disease
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    8 / 6687 (0.12%)
    7 / 6519 (0.11%)
    2 / 5990 (0.03%)
    8 / 6487 (0.12%)
    20 / 12961 (0.15%)
    0 / 2985 (0.00%)
    10 / 13380 (0.07%)
    6 / 13033 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
    0 / 2
    0 / 9
    0 / 20
    0 / 0
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis bacterial
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    3 / 6487 (0.05%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    3 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 2
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    1 / 2985 (0.03%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Puerperal infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    4 / 12961 (0.03%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpartum sepsis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    4 / 6487 (0.06%)
    2 / 12961 (0.02%)
    2 / 2985 (0.07%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 3
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    1 / 6487 (0.02%)
    4 / 12961 (0.03%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 4
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pustule
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salpingitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rickettsiosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SARS-CoV-2 sepsis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic phlebitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scarlet fever
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    1 / 5990 (0.02%)
    4 / 6487 (0.06%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    4 / 12961 (0.03%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis bacterial
         subjects affected / exposed
    0 / 6687 (0.00%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic viral infection
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syphilis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superinfection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suspected COVID-19
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tinea capitis
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    5 / 13380 (0.04%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 6687 (0.01%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    3 / 6487 (0.05%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    2 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 4
    0 / 2
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    2 / 6687 (0.03%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    2 / 6487 (0.03%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    4 / 13380 (0.03%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethritis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    5 / 6687 (0.07%)
    2 / 6519 (0.03%)
    3 / 5990 (0.05%)
    15 / 6487 (0.23%)
    20 / 12961 (0.15%)
    0 / 2985 (0.00%)
    9 / 13380 (0.07%)
    4 / 13033 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 5
    0 / 15
    0 / 24
    0 / 0
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal infection
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 6687 (0.07%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    4 / 6487 (0.06%)
    9 / 12961 (0.07%)
    0 / 2985 (0.00%)
    3 / 13380 (0.02%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 0
    0 / 4
    0 / 9
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    4 / 13380 (0.03%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral myocarditis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    1 / 2985 (0.03%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    19 / 6687 (0.28%)
    4 / 6519 (0.06%)
    1 / 5990 (0.02%)
    17 / 6487 (0.26%)
    16 / 12961 (0.12%)
    3 / 2985 (0.10%)
    23 / 13380 (0.17%)
    3 / 13033 (0.02%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 4
    0 / 1
    0 / 17
    0 / 16
    0 / 3
    0 / 23
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    2 / 6687 (0.03%)
    1 / 6519 (0.02%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    1 / 5990 (0.02%)
    0 / 6487 (0.00%)
    3 / 12961 (0.02%)
    1 / 2985 (0.03%)
    1 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Abnormal weight gain
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    1 / 13033 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 4
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    3 / 6487 (0.05%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    2 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 3
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    2 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic syndrome
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    1 / 12961 (0.01%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    1 / 6487 (0.02%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 6687 (0.00%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    0 / 2985 (0.00%)
    1 / 13380 (0.01%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 6687 (0.01%)
    0 / 6519 (0.00%)
    0 / 5990 (0.00%)
    0 / 6487 (0.00%)
    3 / 12961 (0.02%)
    0 / 2985 (0.00%)
    0 / 13380 (0.00%)
    0 / 13033 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo (Part 1) Placebo (Part 2) TDV (Part 4) Placebo (Part 3) TDV (Part 3) Placebo (Part 4) TDV (Part 1) TDV (Part 2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    527 / 6687 (7.88%)
    0 / 6519 (0.00%)
    409 / 5990 (6.83%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    149 / 2985 (4.99%)
    1260 / 13380 (9.42%)
    0 / 13033 (0.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    337 / 6687 (5.04%)
    0 / 6519 (0.00%)
    206 / 5990 (3.44%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    82 / 2985 (2.75%)
    736 / 13380 (5.50%)
    0 / 13033 (0.00%)
         occurrences all number
    1145
    0
    561
    0
    0
    250
    2475
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    363 / 6687 (5.43%)
    0 / 6519 (0.00%)
    340 / 5990 (5.68%)
    0 / 6487 (0.00%)
    0 / 12961 (0.00%)
    113 / 2985 (3.79%)
    1011 / 13380 (7.56%)
    0 / 13033 (0.00%)
         occurrences all number
    779
    0
    758
    0
    0
    243
    2745
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2015
    Following changes were implemented with Protocol Amendment 2: -The protocol was primarily amended to change the dosing regimen and to modify the long-term febrile surveillance methodology (during Part 3). -Updated the role of Data Monitoring Committee and addition of involvement of Adjudication Committee. -Added second trial vaccination on Day 90 (Month 3). -Updated time window between trial visits and specification of trial procedures for each year of follow-up during Part 3. -Updated trial objectives and endpoints. -Removed conditional booster. -Replacement of enhanced passive hospital-based surveillance by modified active surveillance. -Six-month cap on pre-vaccination surveillance for dengue replaced by 10 months. -Addition of febrile illness surveillance during dry-run. -Updated the section on collection of serious adverse events. -Specifications added on use of interactive web/voice response system (IWRS/IVRS) for subject enrollment/randomisation. -Updates to certain study procedures, statistical analysis, and eligibility criteria.
    18 May 2020
    Following changes were implemented with Protocol Amendment 4: -Added a booster phase to the ongoing DEN-301 trial. -Subheadings were generated to differentiate between Parts 1, 2, and 3 of the trial and the new booster phase of the trial (Parts 4 and 5). -Microneutralization test (MNT) was replaced with MNT50 for consistency. -The term ‘Legally Authorized Representative (LAR)’ was replaced by parent/guardian for consistency. -The administrative trial information was updated and minor grammatical and editorial changes were included.
    20 Apr 2021
    Following changes were implemented with Protocol Amendment 4: - EudraCT Number was added. -Updated the status of the Interim Clinical Study Reports planned for the trial. -Corrected and updated list of References.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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