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    Clinical Trial Results:
    Blinded, randomized, controlled, multicenter study to evaluate the clinical efficacy against varicella disease of GlaxoSmithKline Biologicals' live attenuated varicella vaccine (Varilrix) given on a one-dose schedule and of GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine (Priorix™-Tetra) given on a two-dose schedule in healthy children during the second year of life

    Summary
    EudraCT number
    		 2004-002676-41
    Trial protocol
    		 SE   LT   SK   CZ   IT  
    Global end of trial date
    15 Dec 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Mar 2018
    First version publication date
    01 Jul 2017
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    100388
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00226499
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EXT FU Y2: 104105, EXT FU Y1: 103494, EXT FU Y4-Y6-Y8-Y10: 104106
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To demonstrate the efficacy of one dose of Varilrix in preventing confirmed varicella cases* over at least two years after vaccination. OR/AND •To demonstrate the efficacy of two doses of Priorix-Tetra in preventing confirmed varicella cases* over at least two years after vaccination. * Varicella cases were defined per protocol and according to Center for Disease Control (CDC, 2002) as an illness with an acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) WITHOUT OTHER APPARENT CAUSE.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2005
    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
    Czech Republic: 1286
    Country: Number of subjects enrolled
    Greece: 307
    Country: Number of subjects enrolled
    Italy: 283
    Country: Number of subjects enrolled
    Lithuania: 647
    Country: Number of subjects enrolled
    Norway: 204
    Country: Number of subjects enrolled
    Poland: 946
    Country: Number of subjects enrolled
    Romania: 335
    Country: Number of subjects enrolled
    Russian Federation: 1000
    Country: Number of subjects enrolled
    Slovakia: 491
    Country: Number of subjects enrolled
    Sweden: 304
    Worldwide total number of subjects
    5803
    EEA total number of subjects
    4803
    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)
    5801
    Children (2-11 years)
    2
    Adolescents (12-17 years)
    0
    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
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MMRV Group
    Arm description
    		 Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix–tetra™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group.

    Arm title
    		 OKAH Group
    Arm description
    		 Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Varilrix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose administered subcutaneously at Day 42 to subjects in OKAH Group.

    Investigational medicinal product name
    Priorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group.

    Arm title
    		 MMR Group
    Arm description
    		 Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Priorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group.

    Number of subjects in period 1
    		MMRV Group OKAH Group MMR Group
    Started
    2489
    2487
    827
    Completed
    1415
    1415
    468
    Not completed
    1074
    1072
    359
         Others
    1064
    1066
    356
         Adverse event, non-fatal
    10
    6
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MMRV Group
    Reporting group description
    		 Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

    Reporting group title
    OKAH Group
    Reporting group description
    		 Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.

    Reporting group title
    MMR Group
    Reporting group description
    		 Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

    Reporting group values
    		 MMRV Group OKAH Group MMR Group Total
    Number of subjects
    		 2489 2487 827
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 14.3 ( 2.5 ) 14.2 ( 2.5 ) 14.2 ( 2.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1154 1223 401 2778
        Male
    		 1335 1264 426 3025
    Race/Ethnicity, Customized
    Units: Subjects
        Race American hispanic
    		 1 5 2 8
        Race Arabic/north african
    		 24 7 3 34
        Race Black
    		 9 9 1 19
        Race East/south east asian
    		 8 7 1 16
        Race Japanese
    		 1 0 0 1
        Race Other
    		 13 11 1 25
        Race South asian
    		 3 2 1 6
        Race White/caucasian
    		 2430 2446 818 5694

    End points

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    End points reporting groups
    Reporting group title
    MMRV Group
    Reporting group description
    		 Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

    Reporting group title
    OKAH Group
    Reporting group description
    		 Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.

    Reporting group title
    MMR Group
    Reporting group description
    		 Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

    Primary: Phase A: Number of subjects with confirmed varicella case

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    End point title
    		 Phase A: Number of subjects with confirmed varicella case [1]
    End point description
    Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked [Epi (+)] to a valid index case.
    End point type
    Primary
    End point timeframe
    From 42 days post dose 2 until the end of Phase A
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    2279
    2263
    743
    Units: Participants
        Participants
    37
    243
    201
    No statistical analyses for this end point

    Primary: Phase A: Vaccine efficacy in subjects with confirmed varicella case

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    End point title
    		 Phase A: Vaccine efficacy in subjects with confirmed varicella case [2] [3]
    End point description
    Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group (MMRV and OKAH) compared to a confirmed varicella case in the control group (MMR). Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked [Epi (+)] to a valid index case.
    End point type
    Primary
    End point timeframe
    42 days post dose 2 until the end of Phase A
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this end point were tabulated as vaccine efficacy of Varilrix when compared to Priorix and vaccine efficacy of Priorix-Tetra when compared to Priorix. This endpoint therefore presents the results for groups applicable for this analysis (i.e., MMRV & OKAH Groups).
    End point values
    		 MMRV Group OKAH Group
    Number of subjects analysed
    2279
    2263
    Units: Percentage
        number (confidence interval 97.5%)
    94.943 (92.446 to 96.615)
    65.428 (57.182 to 72.086)
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects with moderate or severe confirmed varicella case

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    End point title
    		 Phase A: Number of subjects with moderate or severe confirmed varicella case
    End point description
    Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
    End point type
    Secondary
    End point timeframe
    From 42 days post dose 2 until the end of Phase A
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    2279
    2263
    743
    Units: Participants
        Participants
    2
    37
    117
    No statistical analyses for this end point

    Secondary: Phase A: Vaccine efficacy in subjects with moderate or severe confirmed varicella case

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    End point title
    		 Phase A: Vaccine efficacy in subjects with moderate or severe confirmed varicella case [4]
    End point description
    VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group (MMRV and OKAH) compared to a moderate or severe confirmed varicella case in the control group (MMR). Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
    End point type
    Secondary
    End point timeframe
    42 days post dose 2 until the end of Phase A
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this end point were tabulated as vaccine efficacy of Varilrix when compared to Priorix and vaccine efficacy of Priorix-Tetra when compared to Priorix. This endpoint therefore presents the results for groups applicable for this analysis (i.e., MMRV & OKAH Groups).
    End point values
    		 MMRV Group OKAH Group
    Number of subjects analysed
    2279
    2263
    Units: Percentage
        number (confidence interval 95%)
    99.498 (97.522 to 99.898)
    90.741 (85.866 to 93.934)
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects with probable or confirmed varicella case

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    End point title
    		 Phase A: Number of subjects with probable or confirmed varicella case
    End point description
    Probable or confirmed varicella = An illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause.
    End point type
    Secondary
    End point timeframe
    From 42 days post dose 2 until the end of Phase A
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    2279
    2263
    743
    Units: Participants
        Participants
    57
    260
    209
    No statistical analyses for this end point

    Secondary: Phase A: Vaccine efficacy in subjects with probable or confirmed varicella case

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    End point title
    		 Phase A: Vaccine efficacy in subjects with probable or confirmed varicella case [5]
    End point description
    VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group (MMRV and OKAH) compared to a probable or confirmed varicella case in the control group (MMR). Probable or confirmed varicella = An illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause.
    End point type
    Secondary
    End point timeframe
    42 days post dose 2 until the end of Phase A
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this end point were tabulated as vaccine efficacy of Varilrix when compared to Priorix and vaccine efficacy of Priorix-Tetra when compared to Priorix. This endpoint therefore presents the results for groups applicable for this analysis (i.e., MMRV & OKAH Groups).
    End point values
    		 MMRV Group OKAH Group
    Number of subjects analysed
    2279
    2263
    Units: Percentage
        number (confidence interval 95%)
    92.487 (89.927 to 94.396)
    64.585 (57.503 to 70.486)
    No statistical analyses for this end point

    Secondary: Phase A: Immune response to varicella vaccine with respect to anti-Varicella Zoster Virus (anti-VZV) antibody concentrations

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    End point title
    		 Phase A: Immune response to varicella vaccine with respect to anti-Varicella Zoster Virus (anti-VZV) antibody concentrations
    End point description
    Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    2245
    2245
    742
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-VZV, Day 0 (N=2245;2245;742)
    12.8 (12.6 to 12.9)
    12.7 (12.6 to 12.8)
    12.6 (12.5 to 12.8)
        Anti-VZV, Day 42 (N=690;697;231)
    116.1 (108.3 to 124.5)
    13.5 (13.0 to 14.1)
    13.1 (12.5 to 13.9)
        Anti-VZV, Day 84 (N=2241;2234;740)
    1833.3 (1767.8 to 1901.3)
    98.1 (94.2 to 102.3)
    14.7 (13.9 to 15.6)
        Anti-VZV, Year 1 (N=2066;2053;673)
    365.1 (349.0 to 381.9)
    145.2 (137.0 to 153.8)
    20.3 (18.2 to 22.5)
        Anti-VZV, Year 2 (N=1924;1916;635)
    414.6 (392.1 to 438.5)
    170.6 (158.1 to 184.1)
    36.9 (31.6 to 43.1)
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects with seroconversion/seroresponse to VZV

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    End point title
    		 Phase A: Number of subjects with seroconversion/seroresponse to VZV
    End point description
    Seronegative (S-) = Subjects with antibody concentration less than (<) 25 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration greater than or equal to (≥) 25 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    2245
    2245
    742
    Units: Participants
        Anti-VZV, Day 0 (N=2245;2245;742)
    26
    24
    4
        Anti-VZV, Day 42 (N=690;697;231)
    661
    21
    6
        Anti-VZV, Day 84 (N=2241;2234;740)
    2236
    2123
    40
        Anti-VZV, Year 1 (N=2066;2053;673)
    2056
    1968
    91
        Anti-VZV, Year 2 (N=1924;1916;635)
    1913
    1776
    170
    No statistical analyses for this end point

    Secondary: Phase A: Immune response to measles with respect to anti-measles antibody concentrations in a subset of subjects

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    End point title
    		 Phase A: Immune response to measles with respect to anti-measles antibody concentrations in a subset of subjects
    End point description
    Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    704
    713
    232
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-measles, Day 0 (N=704;713;232)
    75.7 (74.6 to 76.8)
    77.9 (75.6 to 80.3)
    77.9 (73.9 to 82.1)
        Anti-measles, Day 42 (N=691;698;230)
    3961.0 (3719.7 to 4217.9)
    2602.7 (2429.6 to 2788.1)
    2817.4 (2506.3 to 3167.1)
        Anti-measles, Day 84 (N=704;712;231)
    5809.6 (5544.5 to 6087.3)
    3438.1 (3210.9 to 3681.5)
    3695.0 (3318.2 to 4114.6)
        Anti-measles, Year 1 (N=630;630;200)
    4993.7 (4714.7 to 5289.2)
    2856.8 (2658.6 to 3069.7)
    2885.7 (2520.7 to 3303.5)
        Anti-measles, Year 2 (N=589;593;187)
    4709.6 (4407.1 to 5033.0)
    2624.5 (2423.6 to 2842.2)
    2677.9 (2302.5 to 3114.5)
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects with seroconversion/seroresponse to measles in a subset of subjects

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    End point title
    		 Phase A: Number of subjects with seroconversion/seroresponse to measles in a subset of subjects
    End point description
    Seronegative (S-) = Subjects with antibody concentration < 150 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 150 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    704
    713
    232
    Units: Participants
        Anti-measles, Day 0 (N=704;713;232)
    2
    7
    2
        Anti-measles, Day 42 (N=691;698;230)
    676
    682
    225
        Anti-measles, Day 84 (N=704;712;231)
    703
    702
    230
        Anti-measles, Year 1 (N=630;630;200)
    628
    621
    198
        Anti-measles, Year 2 (N=589;593;187)
    584
    583
    183
    No statistical analyses for this end point

    Secondary: Phase A: Immune response to mumps with respect to anti-mumps antibody concentrations in a subset of subjects

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    End point title
    		 Phase A: Immune response to mumps with respect to anti-mumps antibody concentrations in a subset of subjects
    End point description
    Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    704
    712
    232
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-mumps, Day 0 (N=704;712;232)
    117.5 (115.4 to 119.7)
    119.1 (116.2 to 122.2)
    118.1 (114.4 to 122.0)
        Anti-mumps, Day 42 (N=667;670;225)
    896.6 (827.0 to 972.0)
    925.0 (859.4 to 995.7)
    945.2 (839.0 to 1064.9)
        Anti-mumps, Day 84 (N=698;701;225)
    1496.8 (1407.7 to 1591.7)
    759.8 (705.5 to 818.3)
    1547.9 (1408.0 to 1701.6)
        Anti-mumps, Year 1 (N=624;622;196)
    1008.6 (928.8 to 1095.2)
    875.9 (805.8 to 952.2)
    1089.6 (944.0 to 1257.5)
        Anti-mumps, Year 2 (N=582;587;187)
    1050.6 (957.5 to 1152.7)
    882.0 (805.6 to 965.6)
    989.4 (848.3 to 1153.9)
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects with seroconversion/seroresponse to mumps in a subset of subjects

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    End point title
    		 Phase A: Number of subjects with seroconversion/seroresponse to mumps in a subset of subjects
    End point description
    Seronegative (S-) = Subjects with antibody concentration < 231 U/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 231 U/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    704
    712
    232
    Units: Participants
        Anti-mumps, Day 0 (N=704;712;232)
    4
    6
    2
        Anti-mumps, Day 42 (N=667;670;225)
    584
    613
    208
        Anti-mumps, Day 84 (N=698;701;225)
    683
    608
    225
        Anti-mumps, Year 1 (N=624;622;196)
    569
    554
    182
        Anti-mumps, Year 2 (N=582;587;187)
    527
    520
    171
    No statistical analyses for this end point

    Secondary: Phase A: Immune response to rubella with respect to anti-rubella antibody concentrations in a subset of subjects

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    End point title
    		 Phase A: Immune response to rubella with respect to anti-rubella antibody concentrations in a subset of subjects
    End point description
    Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    704
    713
    232
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-rubella, Day 0 (N=704;713;232)
    2.1 (2.0 to 2.1)
    2.0 (2.0 to 2.1)
    2.1 (2.0 to 2.2)
        Anti-rubella, Day 42 (N=692;698;230)
    57.6 (54.2 to 61.2)
    74.0 (69.9 to 78.3)
    71.0 (64.8 to 77.8)
        Anti-rubella, Day 84 (N=704;712;231)
    104.7 (99.8 to 109.8)
    122.1 (116.2 to 128.2)
    111.9 (103.5 to 120.9)
        Anti-rubella, Year 1 (N=630;630;200)
    88.7 (83.9 to 93.8)
    103.7 (97.8 to 110.0)
    98.0 (88.7 to 108.3)
        Anti-rubella, Year 2 (N=589;593;187)
    71.8 (67.5 to 76.4)
    79.1 (74.2 to 84.3)
    71.8 (64.0 to 80.5)
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects with a seroconversion/seroresponse to rubella in a subset of subjects

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    End point title
    		 Phase A: Number of subjects with a seroconversion/seroresponse to rubella in a subset of subjects
    End point description
    Seronegative (S-) = Subjects with antibody concentration < 4 IU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 4 IU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    704
    713
    232
    Units: Participants
        Anti-rubella, Day 0 (N=704;713;232)
    7
    5
    2
        Anti-rubella, Day 42 (N=692;698;230)
    688
    693
    230
        Anti-rubella, Day 84 (N=704;712;231)
    704
    710
    231
        Anti-rubella, Year 1 (N=630;630;200)
    630
    628
    200
        Anti-rubella, Year 2 (N=589;593;187)
    589
    590
    186
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects with confirmed cases of herpes zoster

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    End point title
    		 Phase A: Number of subjects with confirmed cases of herpes zoster
    End point description
    The number of subjects with confirmed cases of herpes zoster is reported.
    End point type
    Secondary
    End point timeframe
    From Day 0 until the end of Phase A (Year 2)
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    807
    812
    268
    Units: Participants
        Participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects reporting fever

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    End point title
    		 Phase A: Number of subjects reporting fever
    End point description
    All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = Seek for medical advice.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Day 0-42) post-vaccination period following each dose
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    784
    795
    256
    Units: Participants
        All Fever, Dose 1
    503
    439
    132
        Related Fever, Dose 1
    332
    240
    82
        Related Fever ≥ 38°C, Dose 1
    332
    240
    82
        Related Fever > 38.5°C, Dose 1
    222
    147
    46
        Related Fever > 39°C, Dose 1
    141
    90
    29
        Related Fever > 39.5°C, Dose 1
    71
    48
    13
        Related Fever > 40°C, Dose 1
    22
    18
    5
        Fever ≥ 38°C, Dose 1
    503
    439
    132
        Fever > 38.5°C, Dose 1
    359
    297
    84
        Fever > 39°C, Dose 1
    249
    191
    55
        Fever > 39.5°C, Dose 1
    139
    100
    29
        Fever > 40°C, Dose 1
    49
    43
    15
        Fever Medical advice, Dose 1
    203
    177
    46
        All Fever, Dose 2 (N=758;773;247)
    303
    313
    103
        Related Fever, Dose 2 (N=758;773;247)
    136
    144
    41
        Related Fever ≥ 38°C, Dose 2 (N=758;773;247)
    136
    144
    41
        Related Fever > 38.5°C, Dose 2 (N=758;773;247)
    78
    88
    25
        Related Fever > 39°C, Dose 2 (N=758;773;247)
    51
    54
    20
        Related Fever > 39.5°C, Dose 2 (N=758;773;247)
    25
    32
    11
        Related Fever > 40°C, Dose 2 (N=758;773;247)
    9
    9
    3
        Fever ≥ 38°C, Dose 2 (N=758;773;247)
    303
    313
    103
        Fever > 38.5°C, Dose 2 (N=758;773;247)
    212
    205
    69
        Fever > 39°C, Dose 2 (N=758;773;247)
    136
    132
    54
        Fever > 39.5°C, Dose 2 (N=758;773;247)
    66
    74
    30
        Fever > 40°C, Dose 2 (N=758;773;247)
    20
    25
    8
        Fever Medical advice, Dose 2 (N=758;773;247)
    112
    119
    44
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects reporting fever

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    End point title
    		 Phase A: Number of subjects reporting fever
    End point description
    All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related fever = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = Seek for medical advice.
    End point type
    Secondary
    End point timeframe
    Within 15 days (Day 0-14) post-vaccination period following each dose
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    784
    795
    256
    Units: Participants
        All Fever, Dose 1
    450
    354
    102
        Related Fever, Dose 1
    328
    226
    69
        Related Fever ≥ 38°C, Dose 1
    328
    226
    69
        Related Fever > 38.5°C, Dose 1
    216
    134
    36
        Related Fever > 39°C, Dose 1
    135
    82
    23
        Related Fever > 39.5°C, Dose 1
    67
    42
    10
        Related Fever > 40°C, Dose 1
    19
    15
    4
        Fever ≥ 38°C, Dose 1
    449
    349
    101
        Fever > 38.5°C, Dose 1
    300
    213
    54
        Fever > 39°C, Dose 1
    196
    124
    34
        Fever > 39.5°C, Dose 1
    101
    58
    16
        Fever > 40°C, Dose 1
    30
    21
    6
        Fever Medical advice, Dose 1
    140
    100
    26
        All Fever, Dose 2 (N=758;773;247)
    189
    201
    55
        Related Fever, Dose 2 (N=758;773;247)
    118
    125
    32
        Related Fever ≥ 38°C, Dose 2 (N=758;773;247)
    118
    125
    32
        Related Fever > 38.5°C, Dose 2 (N=758;773;247)
    60
    73
    18
        Related Fever > 39°C, Dose 2 (N=758;773;247)
    34
    41
    16
        Related Fever > 39.5°C, Dose 2 (N=758;773;247)
    17
    22
    9
        Related Fever > 40°C, Dose 2 (N=758;773;247)
    6
    5
    3
        Fever ≥ 38°C, Dose 2 (N=758;773;247)
    184
    200
    51
        Fever > 38.5°C, Dose 2 (N=758;773;247)
    101
    110
    30
        Fever > 39°C, Dose 2 (N=758;773;247)
    62
    65
    24
        Fever > 39.5°C, Dose 2 (N=758;773;247)
    28
    35
    14
        Fever > 40°C, Dose 2 (N=758;773;247)
    8
    11
    4
        Fever Medical Advice, Dose 2 (N=758;773;247)
    43
    48
    13
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects reporting solicited local symptoms

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    End point title
    		 Phase A: Number of subjects reporting solicited local symptoms
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom = Occurrence of any local symptom regardless of their intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than (>) 20 mm.
    End point type
    Secondary
    End point timeframe
    4 days post-vaccination period following each dose
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    782
    796
    256
    Units: Participants
        Any Pain, Dose 1
    74
    83
    20
        Grade 3 Pain, Dose 1
    1
    2
    0
        Any Redness, Dose 1
    137
    154
    36
        Grade 3 Redness, Dose 1
    3
    3
    0
        Any Swelling, Dose 1
    38
    37
    6
        Grade 3 Swelling, Dose 1
    3
    0
    0
        Any Pain, Dose 2 (N=758;774;247)
    91
    63
    16
        Grade 3 Pain, Dose 2 (N=758;774;247)
    0
    1
    1
        Any Redness, Dose 2 (N=758;774;247)
    188
    106
    23
        Grade 3 Redness, Dose 2 (N=758;774;247)
    26
    3
    0
        Any Swelling, Dose 2 (N=758;774;247)
    72
    31
    3
        Grade 3 Swelling, Dose 2 (N=758;774;247)
    4
    0
    0
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects reporting meningism

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    End point title
    		 Phase A: Number of subjects reporting meningism
    End point description
    Any = Occurrence of meningism regardless of its intensity grade. Grade 3 meningism = Prevented normal, everyday activities. Related = Assessed by the investigator to be causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Day 0-42) post-vaccination period following each dose
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    784
    795
    256
    Units: Participants
        Any Meningism, Dose 1
    1
    0
    0
        Grade 3 Meningism, Dose 1
    1
    0
    0
        Related Meningism, Dose 1
    1
    0
    0
        Any Meningism, Dose 2 (N=758;773;247)
    0
    1
    0
        Grade 3 Meningism, Dose 2 (N=758;773;247)
    0
    0
    0
        Related Meningism, Dose 2 (N=758;773;247)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects reporting parotitis

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    End point title
    		 Phase A: Number of subjects reporting parotitis
    End point description
    Any = Occurrence of parotitis regardless of its intensity grade. Grade 3 parotitis = Swelling with accompanying general symptoms. Related = Assessed by the investigator to be causally related to the study.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Day 0-42) post-vaccination period following each dose
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    784
    795
    256
    Units: Participants
        Any Parotitis, Dose 1
    4
    5
    1
        Grade 3 Parotitis, Dose 1
    2
    1
    0
        Related Parotitis, Dose 1
    3
    3
    0
        Any Parotitis, Dose 2 (N=758;773;247)
    0
    2
    0
        Grade 3 Parotitis, Dose 2 (N=758;773;247)
    0
    1
    0
        Related Parotitis, Dose 2 (N=758;773;247)
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects reporting rash

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    End point title
    		 Phase A: Number of subjects reporting rash
    End point description
    Any = Occurrence of rash regardless of its intensity grade. Grade 3 rash = 101-500 lesions. Grade 4 rash = > 500 lesions. Related rash = Assessed by the investigator to be causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Day 0-42) post-vaccination period following each dose
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    784
    795
    256
    Units: Participants
        Any Local. or general., Dose 1
    82
    84
    30
        Any Localized, Dose 1
    14
    15
    6
        Localized Admin. site, Dose 1
    0
    1
    0
        Localized Other site, Dose 1
    14
    14
    6
        Any Generalized, Dose 1
    68
    69
    24
        Generalized with fever, Dose 1
    41
    41
    14
        Generalized Measles/Rubella, Dose 1
    30
    24
    9
        Generalized Grade 3/4, Dose 1
    9
    12
    7
        Generalized Grade 4, Dose 1
    2
    2
    4
        Generalized Related, Dose 1
    27
    32
    13
        Any Local. or general., Dose 2 (N=758;773;247)
    42
    36
    9
        Any Localized, Dose 2 (N=758;773;247)
    5
    12
    4
        Localized Admin. site, Dose 2 (N=758;773;247)
    0
    2
    0
        Localized Other site, Dose 2 (N=758;773;247)
    5
    10
    4
        Any Generalized, Dose 2 (N=758;773;247)
    37
    24
    5
        Generalized with fever, Dose 2 (N=758;773;247)
    9
    11
    4
        Generalized Measles/Rubella, Dose 2(N=758;773;247)
    8
    4
    0
        Generalized Grade 3/4, Dose 2 (N=758;773;247)
    5
    6
    1
        Generalized Grade 4, Dose 2 (N=758;773;247)
    2
    1
    0
        Generalized Related, Dose 2 (N=758;773;247)
    12
    6
    1
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects with suspected sign of meningism including febrile convulsions

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    End point title
    		 Phase A: Number of subjects with suspected sign of meningism including febrile convulsions
    End point description
    Any = Occurrence of meningism including febrile convulsions regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Day 0-42) post-vaccination period following each dose
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    784
    795
    256
    Units: Participants
        Meningism, Dose 1
    1
    0
    0
        Meningism, Dose 2 (N=758;773;247)
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects reporting unsolicited Adverse Events (AEs)

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    End point title
    		 Phase A: Number of subjects reporting unsolicited Adverse Events (AEs)
    End point description
    Unsolicited AE assessed included any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Day 0-42) post-vaccination period following each dose
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    807
    812
    268
    Units: Participants
        Any AE(s), Dose 1
    301
    303
    82
        Any AE(s), Dose 2 (N=777;788;253)
    239
    258
    90
    No statistical analyses for this end point

    Secondary: Phase A: Number of subjects reporting Serious Adverse Events (SAEs)

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    End point title
    		 Phase A: Number of subjects reporting Serious Adverse Events (SAEs)
    End point description
    SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    From Day 0 until the end of Phase A (Year 2)
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    2489
    2487
    827
    Units: Participants
        Participants
    473
    480
    148
    No statistical analyses for this end point

    Secondary: Phase A: Health Economics analysis of factors leading to indirect costs due to varicella illness

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    End point title
    		 Phase A: Health Economics analysis of factors leading to indirect costs due to varicella illness
    End point description
    Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).
    End point type
    Secondary
    End point timeframe
    During Phase A (from Day 0 up to Year 2)
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    37
    246
    201
    Units: Hours
    arithmetic mean (standard deviation)
        Time lost from work [hours]
    31.5 ( 22.9 )
    40.5 ( 31.4 )
    48.1 ( 35.3 )
        Time lost for subjects [hours]
    66.4 ( 86.0 )
    49.5 ( 31.9 )
    54.5 ( 36.4 )
        Time of requested assistance [hours]
    34.0 ( 31.1 )
    35.2 ( 51.6 )
    35.4 ( 31.3 )
    No statistical analyses for this end point

    Secondary: Phase B: Number of subjects with confirmed varicella case

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    End point title
    		 Phase B: Number of subjects with confirmed varicella case
    End point description
    Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case.
    End point type
    Secondary
    End point timeframe
    From beginning of Phase B (Year 2) up to study end (Year 10)
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    1800
    1591
    396
    Units: Participants
        Participants
    38
    225
    149
    No statistical analyses for this end point

    Secondary: Phase B: Vaccine efficacy in subjects with confirmed varicella case

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    End point title
    		 Phase B: Vaccine efficacy in subjects with confirmed varicella case [6]
    End point description
    VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group (MMRV and OKAH) compared to a confirmed varicella case in the control group (MMR). Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case.
    End point type
    Secondary
    End point timeframe
    From the beginning of Phase B (Year 2) up to study end (Year 10)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this end point were tabulated as vaccine efficacy of Varilrix when compared to Priorix and vaccine efficacy of Priorix-Tetra when compared to Priorix. This endpoint therefore presents the results for groups applicable for this analysis (i.e., MMRV & OKAH Groups).
    End point values
    		 MMRV Group OKAH Group
    Number of subjects analysed
    1800
    1591
    Units: Percentage
        number (confidence interval 95%)
    95.855 (94.075 to 97.101)
    69.812 (62.848 to 75.470)
    No statistical analyses for this end point

    Secondary: Phase B: Number of subjects with moderate or severe confirmed varicella case

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    End point title
    		 Phase B: Number of subjects with moderate or severe confirmed varicella case
    End point description
    Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
    End point type
    Secondary
    End point timeframe
    From the beginning of Phase B (Year 2) up to study end (Year 10)
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    2279
    2266
    744
    Units: Participants
        Participants
    6
    67
    176
    No statistical analyses for this end point

    Secondary: Phase B: Vaccine efficacy in subjects with moderate or severe confirmed varicella case

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    End point title
    		 Phase B: Vaccine efficacy in subjects with moderate or severe confirmed varicella case [7]
    End point description
    VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group (MMRV and OKAH) compared to a moderate or severe confirmed varicella case in the control group (MMR). Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
    End point type
    Secondary
    End point timeframe
    From the beginning of Phase B (Year 2) up to study end (Year 10)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this end point were tabulated as vaccine efficacy of Varilrix when compared to Priorix and vaccine efficacy of Priorix-Tetra when compared to Priorix. This endpoint therefore presents the results for groups applicable for this analysis (i.e., MMRV & OKAH Groups).
    End point values
    		 MMRV Group OKAH Group
    Number of subjects analysed
    2279
    2266
    Units: Percentage
        number (confidence interval 95%)
    99.072 (97.907 to 99.589)
    89.532 (86.126 to 92.102)
    No statistical analyses for this end point

    Secondary: Phase B: Number of subjects with probable or confirmed varicella case

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    End point title
    		 Phase B: Number of subjects with probable or confirmed varicella case
    End point description
    Probable or confirmed varicella = An illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause.
    End point type
    Secondary
    End point timeframe
    From the beginning of Phase B (Year 2) up to study end (Year 10)
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    1800
    1591
    396
    Units: Participants
        Participants
    49
    237
    152
    No statistical analyses for this end point

    Secondary: Phase B: Vaccine efficacy in subjects with probable or confirmed varicella case

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    End point title
    		 Phase B: Vaccine efficacy in subjects with probable or confirmed varicella case [8]
    End point description
    VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group (MMRV and OKAH) compared to a probable or confirmed varicella case in the control group (MMR). Probable or confirmed varicella = An illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause.
    End point type
    Secondary
    End point timeframe
    From the beginning of Phase B (Year 2) up to study end (Year 10)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this end point were tabulated as vaccine efficacy of Varilrix when compared to Priorix and vaccine efficacy of Priorix-Tetra when compared to Priorix. This endpoint therefore presents the results for groups applicable for this analysis (i.e., MMRV & OKAH Groups).
    End point values
    		 MMRV Group OKAH Group
    Number of subjects analysed
    1800
    1591
    Units: Percentage
        number (confidence interval 95%)
    94.816 (92.838 to 96.248)
    68.932 (61.893 to 74.671)
    No statistical analyses for this end point

    Secondary: Phase B: Characteristics of varicella cases

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    End point title
    		 Phase B: Characteristics of varicella cases
    End point description
    Varicella cases were characterized by type, number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.
    End point type
    Secondary
    End point timeframe
    From the beginning of Phase B (Year 2) up to study end (Year 10)
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    38
    225
    149
    Units: Participants
        Number of varicella cases by subject, 1
    38
    223
    148
        Number of varicella cases by subject, 2
    0
    2
    1
        Varicella type, Any
    38
    225
    149
        Varicella type, Confirmed
    38
    225
    149
        Varicella type, Confirmed PCR
    31
    207
    140
        Varicella type, Confirmed EPI
    7
    18
    9
        Varicella type, Confirmed or Probable
    38
    225
    149
        Varicella type, No case
    0
    0
    0
        Rash: number of lesions, 1-50
    32
    173
    76
        Rash: number of lesions, 51-100
    5
    35
    39
        Rash: number of lesions, 101-500
    1
    15
    27
        Rash: number of lesions, 501+
    0
    0
    7
        Rash: number of lesions, Missing
    0
    2
    0
        Character of most lesions, Macular
    4
    6
    1
        Character of most lesions, Papular
    16
    108
    63
        Character of most lesions, Vesicular
    16
    100
    81
        Character of most lesions, Haemorragic
    2
    6
    4
        Character of most lesions, Missing
    0
    5
    0
        Duration of rash, 0 days
    0
    0
    0
        Duration of rash, 1-5 days
    23
    140
    68
        Duration of rash, 6-10 days
    10
    67
    61
        Duration of rash, 11-15 days
    5
    13
    19
        Duration of rash, 16+ days
    0
    0
    0
        Duration of rash, Missing
    0
    5
    1
        Max. number of lesions [investigator], 1-50
    32
    173
    76
        Max. number of lesions [investigator], 51-100
    5
    35
    39
        Max. number of lesions [investigator], 101-500
    1
    15
    27
        Max. number of lesions [investigator], 501+
    0
    0
    7
        Max. number of lesions [investigator], Missing
    0
    2
    0
        Fever, No fever
    37
    212
    100
        Fever, 38.8°C to 39.9°C
    1
    13
    43
        Fever, 40+ °C
    0
    0
    6
        Systemic sign, Pain in back or abdomen
    6
    27
    27
        Systemic sign, Interstitial pneumonia
    0
    0
    0
        Systemic sign, Encephalitis
    0
    0
    0
        Assessment by investigator, Does not appear ill
    28
    159
    62
        Assessment by investigator, Moderately ill
    10
    64
    80
        Assessment by investigator, Severely ill
    0
    1
    6
        Assessment by investigator, Missing
    0
    1
    1
        Complications, Yes
    0
    0
    0
        Complications, No
    38
    222
    147
        Complications, Missing
    0
    3
    2
        Treatment, Yes
    15
    115
    91
        Treatment, No
    23
    106
    56
        Treatment, Missing
    0
    4
    2
        Outcome, Recovered/resolved
    38
    224
    148
        Outcome, Recovered/resolved with sequelae
    0
    0
    0
        Outcome, Missing
    0
    1
    1
        Intensity of severity, Mild
    34
    198
    91
        Intensity of severity, Moderately severe
    4
    27
    54
        Intensity of severity, Severe
    0
    0
    4
    No statistical analyses for this end point

    Secondary: Phase B: Immune response to varicella vaccine with respect to anti-Varicella Zoster Virus (anti-VZV) antibody concentrations

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    End point title
    		 Phase B: Immune response to varicella vaccine with respect to anti-Varicella Zoster Virus (anti-VZV) antibody concentrations
    End point description
    Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At Year 4, Year 6, Year 8 and Year 10 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    1342
    1142
    242
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-VZV, Year 4 (N=1342;1142;242)
    501.3 (467.8 to 537.1)
    272.7 (246.2 to 302.1)
    32.4 (26.1 to 40.4)
        Anti-VZV, Year 6 (N=1292;1021;176)
    680.6 (635.7 to 728.8)
    417.6 (379.9 to 459.0)
    91.8 (66.3 to 126.9)
        Anti-VZV, Year 8 (N=1146;828;117)
    512.5 (480.3 to 546.8)
    418.5 (383.2 to 457.1)
    146.9 (99.6 to 216.6)
        Anti-VZV, Year 10 (N=1169;831;111)
    471.3 (443.2 to 501.2)
    404.6 (373.0 to 438.8)
    219.6 (149.2 to 323.3)
    No statistical analyses for this end point

    Secondary: Phase B: Number of subjects with anti-VZV antibody concentrations above the cut-off value

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    End point title
    		 Phase B: Number of subjects with anti-VZV antibody concentrations above the cut-off value
    End point description
    The anti-VZV antibody concentration cut-off value assessed was greater than or equal to (≥) 25 mIU/mL, in the sera of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Year 4, Year 6, Year 8 and Year 10 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    1342
    1142
    242
    Units: Participants
        Anti-VZV, Year 4 (N=1342;1142;242)
    1330
    1061
    73
        Anti-VZV, Year 6 (N=1292;1021;176)
    1289
    986
    97
        Anti-VZV, Year 8 (N=1146;828;117)
    1142
    806
    78
        Anti-VZV, Year 10 (N=1169;831;111)
    1164
    818
    81
    No statistical analyses for this end point

    Secondary: Phase B: Immune response to measles with respect to anti-measles antibody concentrations

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    End point title
    		 Phase B: Immune response to measles with respect to anti-measles antibody concentrations
    End point description
    Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At Year 4, Year 6, Year 8 and Year 10 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    410
    409
    137
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-measles, Year 4 (N=410;409;137)
    3290.9 (3025.8 to 3579.2)
    1803.5 (1635.8 to 1988.5)
    1724.4 (1431.7 to 2077.0)
        Anti-measles, Year 6 (N=406;221;137)
    2795.9 (2544.7 to 3072.0)
    1727.7 (1514.3 to 1971.1)
    1369.0 (1125.7 to 1665.0)
        Anti-measles, Year 8 (N=357;125;119)
    2342.0 (2115.3 to 2593.0)
    1575.1 (1296.9 to 1913.1)
    1175.5 (963.6 to 1434.0)
        Anti-measles, Year 10 (N=344;39;116)
    1857.2 (1664.0 to 2072.8)
    997.5 (726.7 to 1369.1)
    913.6 (747.0 to 1117.4)
    No statistical analyses for this end point

    Secondary: Phase B: Number of subjects with anti-measles antibody concentrations above the cut-off value

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    End point title
    		 Phase B: Number of subjects with anti-measles antibody concentrations above the cut-off value
    End point description
    The anti-measles antibody concentration cut-off value assessed was ≥ 150 mIU/mL, in the sera of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Year 4, Year 6, Year 8 and Year 10 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    410
    409
    137
    Units: Participants
        Anti-measles, Year 4 (N=410;409;137)
    407
    402
    131
        Anti-measles, Year 6 (N=406;221;137)
    402
    218
    128
        Anti-measles, Year 8 (N=357;125;119)
    353
    121
    113
        Anti-measles, Year 10 (N=344;39;116)
    339
    39
    109
    No statistical analyses for this end point

    Secondary: Phase B: Immune response to mumps with respect to anti-mumps antibody concentrations

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    End point title
    		 Phase B: Immune response to mumps with respect to anti-mumps antibody concentrations
    End point description
    Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
    End point type
    Secondary
    End point timeframe
    At Year 4, Year 6, Year 8 and Year 10 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    407
    407
    136
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-mumps, Year 4 (N=407;407;136)
    1088.9 (974.9 to 1216.3)
    905.3 (810.0 to 1011.9)
    1059.1 (878.9 to 1276.3)
        Anti-mumps, Year 6 (N=398;217;132)
    999.7 (897.4 to 1113.7)
    920.5 (800.3 to 1058.8)
    1030.3 (879.1 to 1207.6)
        Anti-mumps, Year 8 (N=348;120;117)
    875.7 (781.9 to 980.9)
    865.7 (718.3 to 1043.3)
    869.1 (723.3 to 1044.2)
        Anti-mumps, Year 10 (N=339;37;115)
    889.3 (794.4 to 995.6)
    1054.0 (797.2 to 1393.6)
    912.7 (759.5 to 1096.8)
    No statistical analyses for this end point

    Secondary: Phase B: Number of subjects with anti-mumps antibody concentrations above the cut-off value

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    End point title
    		 Phase B: Number of subjects with anti-mumps antibody concentrations above the cut-off value
    End point description
    The anti-mumps antibody concentration cut-off value assessed was ≥ 231 U/mL, in the sera of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Year 4, Year 6, Year 8 and Year 10 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    407
    407
    136
    Units: Participants
        Anti-mumps, Year 4 (N=407;407;136)
    368
    357
    123
        Anti-mumps, Year 6 (N=398;217;132)
    360
    196
    127
        Anti-mumps, Year 8 (N=348;120;117)
    305
    107
    108
        Anti-mumps, Year 10 (N=339;37;115)
    305
    36
    108
    No statistical analyses for this end point

    Secondary: Phase B: Immune response to rubella with respect to anti-rubella antibody concentrations

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    End point title
    		 Phase B: Immune response to rubella with respect to anti-rubella antibody concentrations
    End point description
    Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Year 4, Year 6, Year 8 and Year 10 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    407
    410
    137
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-rubella, Year 4 (N=407;410;137)
    44.4 (40.9 to 48.3)
    50.8 (46.8 to 55.2)
    49.0 (42.9 to 55.9)
        Anti-rubella, Year 6 (N=403;224;137)
    30.1 (27.9 to 32.4)
    34.0 (30.6 to 37.7)
    33.3 (29.2 to 37.9)
        Anti-rubella, Year 8 (N=354;124;119)
    20.8 (19.0 to 22.9)
    26.7 (22.7 to 31.5)
    23.3 (19.8 to 27.3)
        Anti-rubella, Year 10 (N=342;39;116)
    18.8 (17.0 to 20.7)
    29.2 (22.7 to 37.7)
    20.8 (17.6 to 24.6)
    No statistical analyses for this end point

    Secondary: Phase B: Number of subjects with anti-rubella antibody concentrations above the cut-off value

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    End point title
    		 Phase B: Number of subjects with anti-rubella antibody concentrations above the cut-off value
    End point description
    The anti-rubella antibody concentration cut-off value assessed was ≥ 4 IU/mL, in the sera of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    At Year 4, Year 6, Year 8 and Year 10 time points
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    407
    410
    137
    Units: Participants
        Anti-rubella, Year 4 (N=407;410;137)
    407
    408
    137
        Anti-rubella, Year 6 (N=403;224;137)
    402
    222
    136
        Anti-rubella, Year 8 (N=354;124;119)
    347
    120
    116
        Anti-rubella, Year 10 (N=342;39;116)
    334
    39
    112
    No statistical analyses for this end point

    Secondary: Phase B: Characteristics of zoster cases

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    End point title
    		 Phase B: Characteristics of zoster cases [9]
    End point description
    Zoster cases were characterized by number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.
    End point type
    Secondary
    End point timeframe
    From 6 weeks after Dose 2 until study end (Year 10)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects in the MMRV group reported zoster cases. This endpoint therefore presents the results for OKAH & MMR Groups only.
    End point values
    		 OKAH Group MMR Group
    Number of subjects analysed
    4
    2
    Units: Participants
        Rash: number of lesions, 1-50
    4
    2
        Rash: number of lesions, 51-100
    0
    0
        Rash: number of lesions, 101-500
    0
    0
        Rash: number of lesions, 501+
    0
    0
        Character of most lesions, Macular
    0
    0
        Character of most lesions, Papular
    2
    1
        Character of most lesions, Vesicular
    2
    1
        Character of most lesions, Haemorrhagic
    0
    0
        Duration of rash, 0 days
    0
    0
        Duration of rash, 1-5 days
    0
    1
        Duration of rash, 6-10 days
    1
    0
        Duration of rash, 11-15 days
    3
    1
        Duration of rash, 16+ days
    0
    0
        Max. number of lesions [investigator], 1-50
    4
    2
        Max. number of lesions [investigator], 51-100
    0
    0
        Max. number of lesions [investigator], 101-500
    0
    0
        Max. number of lesions [investigator], 501+
    0
    0
        Fever, No fever
    4
    2
        Fever, 38.8°C to 39.9°C
    0
    0
        Fever, 40+ °C
    0
    0
        Systemic signs, Pain in back or abdomen
    2
    1
        Systemic signs, Interstitial pneumonia
    0
    0
        Systemic signs, Encephalitis
    0
    0
        Assessment by investigator, Does not appear ill
    3
    2
        Assessment by investigator, Moderately ill
    1
    0
        Assessment by investigator, Severely ill
    0
    0
        Complications, Yes
    0
    0
        Complications, No
    4
    2
        Treatment, Yes
    2
    1
        Treatment, No
    2
    1
        Outcome, Recovered/resolved
    4
    2
        Outcome, Recovered/resolved with sequelae
    0
    0
        Intensity of severity, Mild
    4
    2
        Intensity of severity, Moderately severe
    0
    0
        Intensity of severity, Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Phase B: Number of subjects reporting Serious Adverse Events (SAEs)

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    End point title
    		 Phase B: Number of subjects reporting Serious Adverse Events (SAEs)
    End point description
    SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    From the beginning of Phase B (Year 2) up to study end (Year 10)
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    1961
    1978
    641
    Units: Participants
        Participants
    290
    317
    93
    No statistical analyses for this end point

    Secondary: Phase B: Health Economics analysis of factors leading to indirect costs due to varicella illness

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    End point title
    		 Phase B: Health Economics analysis of factors leading to indirect costs due to varicella illness
    End point description
    Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).
    End point type
    Secondary
    End point timeframe
    During Phase B
    End point values
    		 MMRV Group OKAH Group MMR Group
    Number of subjects analysed
    38
    227
    150
    Units: Hours
    arithmetic mean (standard deviation)
        Time lost from work [hours]
    42.8 ( 44.1 )
    44.6 ( 31.1 )
    57.8 ( 36.8 )
        Time lost for subjects [hours]
    40.7 ( 35.6 )
    48.0 ( 34.1 )
    57.2 ( 36.1 )
        Time of requested assistance [hours]
    0 ( 0 )
    45.7 ( 21.5 )
    49.4 ( 50.0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local AEs: 4-days (Days 0-3) post dose 1 (Day 0) and dose 2 (Day 42). Solicited general and unsolicited AEs: 43-days (Days 0-42) post dose 1 (Day 0) and dose 2 (Day 42). Serious adverse events: From Day 0 up to the end of study (Year 10).
    Adverse event reporting additional description
    For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    MMRV Group
    Reporting group description
    		 Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

    Reporting group title
    MMR Group
    Reporting group description
    		 Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

    Reporting group title
    OKAH Group
    Reporting group description
    		 Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.

    Serious adverse events
    		 MMRV Group MMR Group OKAH Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    649 / 2489 (26.07%)
    208 / 827 (25.15%)
    681 / 2487 (27.38%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute lymphocytic leukaemia
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute lymphocytic leukaemia recurrent
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Astrocytoma, low grade
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign bone neoplasm
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal papilloma
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medulloblastoma
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melanocytic naevus
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephroblastoma
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroblastoma
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteochondroma
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papilloma
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyosarcoma
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin papilloma
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Teratoma
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kawasaki's disease
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Circumcision
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Accidental death
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Chest pain
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crying
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Granuloma
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperpyrexia
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperthermia malignant
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ill-defined disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue inflammation
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergic oedema
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaphylactoid reaction
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atopy
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immunodeficiency
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Balanoposthitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penile adhesion
         subjects affected / exposed
    3 / 2489 (0.12%)
    1 / 827 (0.12%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penis disorder
         subjects affected / exposed
    3 / 2489 (0.12%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular appendage torsion
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular atrophy
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular retraction
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    111 / 2489 (4.46%)
    39 / 827 (4.72%)
    123 / 2487 (4.95%)
         occurrences causally related to treatment / all
    0 / 116
    0 / 39
    0 / 129
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    11 / 2489 (0.44%)
    5 / 827 (0.60%)
    8 / 2487 (0.32%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal obstruction
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngospasm
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinitis allergic
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    7 / 2489 (0.28%)
    3 / 827 (0.36%)
    6 / 2487 (0.24%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vocal cord thickening
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adjustment disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adjustment disorder with mixed anxiety and depressed mood
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Affective disorder
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    3 / 2489 (0.12%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breath holding
         subjects affected / exposed
    3 / 2489 (0.12%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enuresis
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Learning disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurosis
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nightmare
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychomotor retardation
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reading disorder
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tic
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Medical observation
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accident
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accidental exposure to product
         subjects affected / exposed
    4 / 2489 (0.16%)
    1 / 827 (0.12%)
    10 / 2487 (0.40%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthropod sting
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bite
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burn oral cavity
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chemical injury
         subjects affected / exposed
    3 / 2489 (0.12%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chemical poisoning
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Child maltreatment syndrome
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    23 / 2489 (0.92%)
    7 / 827 (0.85%)
    26 / 2487 (1.05%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 8
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    15 / 2489 (0.60%)
    2 / 827 (0.24%)
    13 / 2487 (0.52%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 2
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dislocation of vertebra
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exposure to toxic agent
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye contusion
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye injury
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    6 / 2489 (0.24%)
    0 / 827 (0.00%)
    9 / 2487 (0.36%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    3 / 2489 (0.12%)
    2 / 827 (0.24%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    8 / 2489 (0.32%)
    0 / 827 (0.00%)
    9 / 2487 (0.36%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heat stroke
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    5 / 2489 (0.20%)
    0 / 827 (0.00%)
    9 / 2487 (0.36%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kidney contusion
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    4 / 2489 (0.16%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver contusion
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal injury
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Near drowning
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck injury
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Open fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic injury
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penile contusion
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Poisoning deliberate
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    4 / 2489 (0.16%)
    1 / 827 (0.12%)
    6 / 2487 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin wound
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Struck by lightning
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    6 / 2489 (0.24%)
    1 / 827 (0.12%)
    9 / 2487 (0.36%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tongue injury
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth injury
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    2 / 2489 (0.08%)
    2 / 827 (0.24%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venomous sting
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    4 / 2489 (0.16%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Anomaly of external ear congenital
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial septal defect
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Choledochal cyst
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital cystic kidney disease
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital inguinal hernia
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital oral malformation
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cryptorchism
         subjects affected / exposed
    3 / 2489 (0.12%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystic fibrosis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Double ureter
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duane's syndrome
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hereditary pancreatitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernia congenital
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    8 / 2489 (0.32%)
    0 / 827 (0.00%)
    5 / 2487 (0.20%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurofibromatosis
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    12 / 2489 (0.48%)
    2 / 827 (0.24%)
    5 / 2487 (0.20%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Primary ciliary dyskinesia
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thalassaemia beta
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cyanosis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Long qt syndrome
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Autism
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign rolandic epilepsy
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cluster headache
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coordination abnormal
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysgraphia
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyslexia
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    4 / 2489 (0.16%)
    1 / 827 (0.12%)
    5 / 2487 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    21 / 2489 (0.84%)
    4 / 827 (0.48%)
    20 / 2487 (0.80%)
         occurrences causally related to treatment / all
    3 / 23
    1 / 4
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intellectual disability
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Language disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral nerve palsy
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postictal state
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    5 / 2487 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Speech disorder developmental
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Abdominal lymphadenopathy
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    6 / 2489 (0.24%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic diathesis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    7 / 2489 (0.28%)
    1 / 827 (0.12%)
    9 / 2487 (0.36%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear deformity acquired
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    External ear disorder
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inner ear disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otorrhoea
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Astigmatism
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chalazion
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eyelid oedema
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inflammation of lacrimal passage
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papilloedema
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Strabismus
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    7 / 2489 (0.28%)
    5 / 827 (0.60%)
    14 / 2487 (0.56%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal stenosis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aphthous ulcer
         subjects affected / exposed
    3 / 2489 (0.12%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coeliac disease
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dental caries
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    4 / 2489 (0.16%)
    0 / 827 (0.00%)
    6 / 2487 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    6 / 2489 (0.24%)
    2 / 827 (0.24%)
    7 / 2487 (0.28%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    4 / 2489 (0.16%)
    0 / 827 (0.00%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    31 / 2489 (1.25%)
    9 / 827 (1.09%)
    22 / 2487 (0.88%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 9
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    3 / 2489 (0.12%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    13 / 2489 (0.52%)
    5 / 827 (0.60%)
    16 / 2487 (0.64%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lip disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Teething
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth loss
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    6 / 2489 (0.24%)
    1 / 827 (0.12%)
    5 / 2487 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    5 / 2489 (0.20%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder disorder
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    6 / 2489 (0.24%)
    3 / 827 (0.36%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis atopic
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythema nodosum
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Henoch-schonlein purpura
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prurigo
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash papular
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash vesicular
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin burning sensation
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    4 / 2489 (0.16%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis acute
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis chronic
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Micturition disorder
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pollakiuria
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal haematoma
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 2489 (0.04%)
    2 / 827 (0.24%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vesicoureteric reflux
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Endocrine disorder
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroiditis
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    3 / 2489 (0.12%)
    2 / 827 (0.24%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone disorder
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exostosis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Growth retardation
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Juvenile idiopathic arthritis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periostitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rickets
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sacroiliitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Torticollis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess neck
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    2 / 827 (0.24%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenoiditis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    14 / 2489 (0.56%)
    5 / 827 (0.60%)
    12 / 2487 (0.48%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascariasis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial diarrhoea
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteriuria
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Body tinea
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Borrelia infection
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    2 / 827 (0.24%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    47 / 2489 (1.89%)
    15 / 827 (1.81%)
    51 / 2487 (2.05%)
         occurrences causally related to treatment / all
    0 / 55
    0 / 15
    0 / 65
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis haemophilus
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis orbital
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic tonsillitis
         subjects affected / exposed
    3 / 2489 (0.12%)
    2 / 827 (0.24%)
    9 / 2487 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    3 / 2489 (0.12%)
    1 / 827 (0.12%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    4 / 2489 (0.16%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eczema impetiginous
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    5 / 2489 (0.20%)
    6 / 827 (0.73%)
    5 / 2487 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterobiasis
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epstein-barr virus infection
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythema infectiosum
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye infection
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis viral
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    67 / 2489 (2.69%)
    26 / 827 (3.14%)
    71 / 2487 (2.85%)
         occurrences causally related to treatment / all
    0 / 74
    0 / 28
    0 / 79
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    27 / 2489 (1.08%)
    13 / 827 (1.57%)
    42 / 2487 (1.69%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 13
    0 / 42
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    9 / 2487 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal bacterial overgrowth
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    H1n1 influenza
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis a
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    3 / 2489 (0.12%)
    2 / 827 (0.24%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    5 / 2489 (0.20%)
    0 / 827 (0.00%)
    7 / 2487 (0.28%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    39 / 2489 (1.57%)
    8 / 827 (0.97%)
    45 / 2487 (1.81%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 8
    0 / 56
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis borrelia
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningococcal sepsis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Molluscum contagiosum
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal abscess
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    17 / 2489 (0.68%)
    3 / 827 (0.36%)
    6 / 2487 (0.24%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroborreliosis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    2 / 2489 (0.08%)
    2 / 827 (0.24%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oropharyngitis fungal
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    17 / 2489 (0.68%)
    3 / 827 (0.36%)
    7 / 2487 (0.28%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    5 / 2489 (0.20%)
    0 / 827 (0.00%)
    7 / 2487 (0.28%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overgrowth bacterial
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parvovirus b19 infection
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    20 / 2489 (0.80%)
    2 / 827 (0.24%)
    13 / 2487 (0.52%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 2
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    6 / 2489 (0.24%)
    3 / 827 (0.36%)
    10 / 2487 (0.40%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    70 / 2489 (2.81%)
    30 / 827 (3.63%)
    63 / 2487 (2.53%)
         occurrences causally related to treatment / all
    0 / 80
    0 / 31
    0 / 66
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudocroup
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 2489 (0.12%)
    3 / 827 (0.36%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    4 / 2489 (0.16%)
    1 / 827 (0.12%)
    7 / 2487 (0.28%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    4 / 2489 (0.16%)
    2 / 827 (0.24%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    6 / 2489 (0.24%)
    1 / 827 (0.12%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scarlet fever
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    7 / 2489 (0.28%)
    5 / 827 (0.60%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    23 / 2489 (0.92%)
    7 / 827 (0.85%)
    18 / 2487 (0.72%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 9
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    4 / 2489 (0.16%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis streptococcal
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxocariasis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    9 / 2489 (0.36%)
    3 / 827 (0.36%)
    4 / 2487 (0.16%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis of intrathoracic lymph nodes
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 2489 (0.32%)
    3 / 827 (0.36%)
    9 / 2487 (0.36%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    6 / 2489 (0.24%)
    1 / 827 (0.12%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    4 / 2489 (0.16%)
    4 / 827 (0.48%)
    11 / 2487 (0.44%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral myositis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral pharyngitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral tonsillitis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    5 / 2489 (0.20%)
    5 / 827 (0.60%)
    9 / 2487 (0.36%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulvitis
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    9 / 2489 (0.36%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    2 / 2489 (0.08%)
    1 / 827 (0.12%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    2 / 2489 (0.08%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    0 / 2489 (0.00%)
    1 / 827 (0.12%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lactose intolerance
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    2 / 2487 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 2489 (0.00%)
    0 / 827 (0.00%)
    1 / 2487 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 2489 (0.04%)
    1 / 827 (0.12%)
    3 / 2487 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight gain poor
         subjects affected / exposed
    1 / 2489 (0.04%)
    0 / 827 (0.00%)
    0 / 2487 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4.98%
    Non-serious adverse events
    		 MMRV Group MMR Group OKAH Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    666 / 2489 (26.76%)
    204 / 827 (24.67%)
    641 / 2487 (25.77%)
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    244 / 2489 (9.80%)
    43 / 827 (5.20%)
    183 / 2487 (7.36%)
         occurrences all number
    325
    60
    260
    Injection site pain
         subjects affected / exposed
    124 / 2489 (4.98%)
    31 / 827 (3.75%)
    111 / 2487 (4.46%)
         occurrences all number
    165
    37
    146
    Pyrexia
         subjects affected / exposed
    604 / 2489 (24.27%)
    188 / 827 (22.73%)
    574 / 2487 (23.08%)
         occurrences all number
    849
    253
    790

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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