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    Clinical Trial Results:
    Single-Blind, randomized, Phase III B Study in children aged 1-11 years to investigate the immunogenicity, safety and interchangeability of two tick-borne encephalitis (TBE) vaccines administered according to a conventional schedule

    Summary
    EudraCT number
    2008-002691-10
    Trial protocol
    AT   CZ  
    Global end of trial date
    20 May 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jun 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    700801
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00840801
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Alias: B9371022
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.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
    13 Oct 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25 milliliter (mL) Junior or Encepur 0.25 mL children and the third vaccination with FSME-IMMUN 0.25 mL Junior only, administered according the conventional schedule (0, 28 and 360 days).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Feb 2009
    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
    Austria: 140
    Country: Number of subjects enrolled
    Czech Republic: 162
    Worldwide total number of subjects
    302
    EEA total number of subjects
    302
    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)
    100
    Children (2-11 years)
    202
    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
    The study was conducted from 06 February 2009 to 20 May 2010 in Austria and Czech Republic

    Period 1
    Period 1 title
    Part A: Screening-Day 28 postdose 2
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part A: FSME-IMMUN
    Arm description
    Subjects received FSME-IMMUN Junior (FSME-IMMUN) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule and received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    FSME-IMMUN
    Investigational medicinal product code
    Other name
    FSME-IMMUN 0.25 mL Junior
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule.

    Arm title
    Part A: Encepur
    Arm description
    Subjects received Encepur Children (Encepur) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule and received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination.
    Arm type
    Active comparator

    Investigational medicinal product name
    Encepur
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single dose of 0.25 mL Encepur Children (Encepur) suspension at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule.

    Number of subjects in period 1
    Part A: FSME-IMMUN Part A: Encepur
    Started
    150
    152
    Completed
    149
    152
    Not completed
    1
    0
         Screen failure
             1
             -
    Period 2
    Period 2 title
    Part B:Day 28 postdose2-Day 28 postdose3
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Part B: FSME-IMMUN
    Arm description
    Subjects received FSME-IMMUN or Encepur during the first and second vaccination, received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    FSME-IMMUN
    Investigational medicinal product code
    Other name
    FSME-IMMUN 0.25 mL Junior
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single dose of 0.25 milliliter FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 360 as the third vaccination.

    Number of subjects in period 2
    Part B: FSME-IMMUN
    Started
    301
    Completed
    297
    Not completed
    4
         Refused blood draw
             2
         Unspecified
             1
         Lost to follow-up
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: FSME-IMMUN
    Reporting group description
    Subjects received FSME-IMMUN Junior (FSME-IMMUN) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule and received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination.

    Reporting group title
    Part A: Encepur
    Reporting group description
    Subjects received Encepur Children (Encepur) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule and received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination.

    Reporting group values
    Part A: FSME-IMMUN Part A: Encepur Total
    Number of subjects
    150 152 302
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn ­ gestational age < 37 wk
    0 0 0
        Newborns (0­-27 days)
    0 0 0
        Infants and toddlers (28 days-­23 months)
    50 50 100
        Children (2­-11 years)
    100 102 202
        Adolescents (12­-17 years)
    0 0 0
        Adults (18­-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    77 74 151
        Male
    73 78 151

    End points

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    End points reporting groups
    Reporting group title
    Part A: FSME-IMMUN
    Reporting group description
    Subjects received FSME-IMMUN Junior (FSME-IMMUN) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule and received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination.

    Reporting group title
    Part A: Encepur
    Reporting group description
    Subjects received Encepur Children (Encepur) at Day 0 and 28 as first and second vaccination according to the conventional immunization schedule and received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination.
    Reporting group title
    Part B: FSME-IMMUN
    Reporting group description
    Subjects received FSME-IMMUN or Encepur during the first and second vaccination, received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination.

    Subject analysis set title
    FSME-IMMUN-Third Vaccination
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety analysis set included subjects who received FSME-IMMUN or Encepur during the first and second vaccination, received FSME-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination

    Subject analysis set title
    FSME-IMMUN
    Subject analysis set type
    Full analysis
    Subject analysis set description
    It Included subjects who received FSME-IMMUN during the first and second vaccination.

    Subject analysis set title
    Encepur
    Subject analysis set type
    Full analysis
    Subject analysis set description
    It Included subjects who received Encepur during the first and second vaccination.

    Primary: Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination

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    End point title
    Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination
    End point description
    Percentage of subjects achieving NT titer greater than or equal to (>=) 10. Per-protocol population included eligible subjects who received first and second vaccination, had negative baseline values in NT, had immunogenicity measurements available at baseline and 28 days after the second vaccination, and no major protocol violations. Here, "Number of subjects analyzed (N)"= total subjects who were evaluable for this end point.
    End point type
    Primary
    End point timeframe
    28 days after the second vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    127
    134
    Units: Percentage of subjects
        number (confidence interval 95%)
    100 (97.1 to 100)
    97.8 (93.6 to 99.5)
    Statistical analysis title
    Non-inferiority Test on Seropositive Response Rate
    Comparison groups
    FSME-IMMUN v Encepur
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    < 0.001
    Method
    Stratified score test
    Confidence interval
    Notes
    [1] - A stratified score test was used to test the non-inferiority with a margin of -10% at 2.5% type I error (one-sided).

    Secondary: Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination

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    End point title
    Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination
    End point description
    Percentage of subjects with NT titer >=10. Modified intent-to-treat (mITT) population included eligible subjects who fulfilled all inclusion and exclusion criteria, received first and second vaccination, did not have positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT,had immunogenicity measurements available at baseline and 28 days after the second vaccination. "Number of subjects analysed"= total number of subjects included in the mITT population. Here, N= number of subjects who were evaluable at specified timeframe.
    End point type
    Secondary
    End point timeframe
    180 days after the first vaccination, 28 days after the third vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    149
    152
    Units: Percentage of subjects
    number (confidence interval 95%)
        180 Days after Vaccination 1 (N=129, 133)
    95.3 (90.2 to 98.3)
    91 (84.8 to 95.3)
        28 Days after Vaccination 3 (N=128, 132)
    100 (97.2 to 100)
    100 (97.2 to 100)
    No statistical analyses for this end point

    Secondary: Seropositivity Rate Determined by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination

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    End point title
    Seropositivity Rate Determined by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
    End point description
    Proportion of subjects with IMMUNOZYM ELISA >126 Vienna Units per milliliter (VIEU/mL) or Enzygnost ELISA >10.32 U/mL. Modified intent-to-treat (mITT) population included eligible subjects who fulfilled all inclusion and exclusion criteria, received first and second vaccination, did not have positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT,had immunogenicity measurements available at baseline and 28 days after the second vaccination. "Number of subjects analysed" =total number of subjects included in the mITT population. Here, N= number of subjects who were evaluable at specified timeframe.
    End point type
    Secondary
    End point timeframe
    28 days after the second vaccination, 180 days after the first vaccination, 28 days after the third vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    149
    152
    Units: Percentage of subjects
    number (confidence interval 95%)
        180 Days after Vaccination 1 (N=142, 146)
    95.1 (90.1 to 98)
    81.5 (74.2 to 87.4)
        28 Days after Vaccination 2 (N=143, 148)
    100 (97.5 to 100)
    97.3 (93.2 to 99.3)
        28 Days after Vaccination 3 (N=141, 145)
    100 (97.4 to 100)
    100 (97.5 to 100)
    No statistical analyses for this end point

    Secondary: Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination

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    End point title
    Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
    End point description
    Geometric mean of antibody response measured by NT. Modified intent-to-treat (mITT) population included eligible subjects who fulfilled all inclusion and exclusion criteria, received first and second vaccination, did not have positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT, had immunogenicity measurements available at baseline and 28 days after the second vaccination. "Number of subjects analysed"= total number of subjects included in the mITT population. Here, N= number of subjects who were evaluable at specified timeframe.
    End point type
    Secondary
    End point timeframe
    28 days after the second vaccination, 180 days after the first vaccination, 28 days after the third vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    149
    152
    Units: titer
    geometric mean (confidence interval 95%)
        180 Days after Vaccination 1 (N=129, 133)
    39.7 (34.4 to 45.8)
    25 (21.3 to 29.4)
        28 Days after Vaccination 2 (N=129, 135)
    236.8 (199.6 to 281)
    118.8 (97.5 to 144.9)
        28 Days after Vaccination 3 (N=128, 132)
    538.2 (499.2 to 580.2)
    521.3 (476.6 to 570.2)
    No statistical analyses for this end point

    Secondary: Antibody Response Measured by ELISA 28 days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination

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    End point title
    Antibody Response Measured by ELISA 28 days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
    End point description
    Geometric mean of antibody response measured by IMMUNOZYM ELISA (VIEU/mL) and Enzygnost ELISA (U/mL). Modified intent-to-treat (mITT) population included eligible subjects who fulfilled all inclusion and exclusion criteria, received first and second vaccination, did not have positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT, had immunogenicity measurements available at baseline and 28 days after the second vaccination. "Number of subjects analysed"= total number of subjects included in the mITT population. Here, N= number of subjects who were evaluable at specified timeframe for the specified ELISA assay.
    End point type
    Secondary
    End point timeframe
    28 days after the second vaccination, 180 days after the first vaccination, 28 days after the third vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    149
    152
    Units: titer
    geometric mean (confidence interval 95%)
        IMMUNOZYM: 180 Days after Vaccination 1(N=142,147)
    493.7 (436.5 to 558.5)
    161.2 (140.5 to 184.9)
        IMMUNOZYM: 28 Days after Vaccination 2(N=143,149)
    3026.3 (2652.2 to 3453.2)
    678 (561.2 to 819.2)
        IMMUNOZYM: 28 Days after Vaccination 3(N=141,146)
    11292.9 (9693.5 to 13156.3)
    10508.6 (8208.4 to 13453.3)
        Enzygnost: 180 Days after Vaccination 1(N=148,149)
    47.9 (41.4 to 55.4)
    26.7 (22.5 to 31.6)
        Enzygnost: 28 Days after Vaccination 2(N=149,151)
    163.3 (152.8 to 174.5)
    93.7 (81.6 to 107.5)
        Enzygnost: 28 Days after Vaccination 3(N=147,148)
    682.2 (579.6 to 802.9)
    673.2 (533.4 to 849.7)
    No statistical analyses for this end point

    Secondary: Fold Increase of Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline

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    End point title
    Fold Increase of Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
    End point description
    Geometric mean of fold increase of antibody response measured by NT from day 0 to specified timeframe. Modified intent-to-treat (mITT) population included eligible subjects who fulfilled all inclusion and exclusion criteria, received first and second vaccination, did not have positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT, had immunogenicity measurements available at baseline and 28 days after the second vaccination. "Number of subjects analysed"= total number of subjects included in the mITT population. Here, N= number of subjects who were evaluable at specified timeframe.
    End point type
    Secondary
    End point timeframe
    28 days after the second vaccination, 180 days after the first vaccination, 28 days after the third vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    149
    152
    Units: fold rise
    geometric mean (confidence interval 95%)
        180 Days after Vaccination 1 (N=129, 133)
    7.9 (6.8 to 9.1)
    5 (4.2 to 5.8)
        28 Days after Vaccination 2 (N=129, 135)
    46.9 (39.5 to 55.8)
    23.6 (19.4 to 28.8)
        28 Days after Vaccination 3 (N=128, 132)
    106.7 (98.5 to 115.5)
    103.5 (94.6 to 113.2)
    No statistical analyses for this end point

    Secondary: Fold Increase of Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline

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    End point title
    Fold Increase of Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
    End point description
    Geometric mean of fold increase of antibody response measured by IMMUNOZYM ELISA (VIEU/ml) and Enzygnost ELISA (U/ml) from day 0 to sepcified timeframe. Modified intent-to-treat (mITT) population included eligible subjects who fulfilled all inclusion and exclusion criteria, received first and second vaccination, did not have positive baseline values in ELISA (IMMUNOZYM FSME ELISA and Enzygnost TBE ELISA) and NT, had immunogenicity measurements available at baseline and 28 days after the second vaccination. "Number of subjects analysed"= total number of subjects included in the mITT population. Here, N= number of subjects who were evaluable at specified timeframe for the specified ELISA assay.
    End point type
    Secondary
    End point timeframe
    28 days after the second vaccination, 180 days after the first vaccination, 28 days after the third vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    149
    152
    Units: fold rise
    geometric mean (confidence interval 95%)
        IMMUNOZYM: 180 Days after Vaccination 1(N=142,147)
    31.6 (26.8 to 37.2)
    9.5 (8.1 to 11)
        IMMUNOZYM: 28 Days after Vaccination 2(N=143,149)
    193.7 (163 to 230.1)
    39.9 (32.5 to 49)
        IMMUNOZYM: 28 Days after Vaccination 3(N=141,146)
    719.9 (591.5 to 876.3)
    620.9 (479.7 to 803.6)
        Enzygnost: 180 Days after Vaccination 1(N=148,149)
    9.5 (8.2 to 11)
    5.3 (4.5 to 6.3)
        Enzygnost: 28 Days after Vaccination 2(N=149,151)
    32.5 (30.4 to 34.8)
    18.7 (16.3 to 21.5)
        Enzygnost: 28 Days after Vaccination 3(N=147,148)
    135.8 (115.3 to 160)
    134.6 (106.7 to 169.9)
    No statistical analyses for this end point

    Secondary: Frequency and Severity of Systemic Reactions Occuring After First Vaccination

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    End point title
    Frequency and Severity of Systemic Reactions Occuring After First Vaccination
    End point description
    Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 - 2 years of age; malaise and fatigue in subjects 3 - 11 years of age (Stratum B) as collected in subject diary. The safety analysis set contains all subjects who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur.
    End point type
    Secondary
    End point timeframe
    Within 28 days after the first vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    150
    152
    Units: subjects
        Systemic reactions: None
    136
    134
        Systemic reactions: Mild
    13
    15
        Systemic reactions: Moderate
    1
    3
        Systemic reactions: Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Frequency and Severity of Systemic Reactions Occuring After Second Vaccination

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    End point title
    Frequency and Severity of Systemic Reactions Occuring After Second Vaccination
    End point description
    Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 - 2 years of age; malaise and fatigue in subjects 3 - 11 years of age (Stratum B) as collected in subject diary. The safety analysis set contains all subjects who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur.
    End point type
    Secondary
    End point timeframe
    Within 28 days after the second vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    150
    152
    Units: subjects
        Systemic reactions: None
    143
    144
        Systemic reactions: Mild
    7
    8
        Systemic reactions: Moderate
    0
    0
        Systemic reactions: Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Frequency and Severity of Systemic Reactions Occuring After Third Vaccination

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    End point title
    Frequency and Severity of Systemic Reactions Occuring After Third Vaccination
    End point description
    Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 - 2 years of age; malaise and fatigue in subjects 3 - 11 years of age (Stratum B) as collected in subject diary. The safety analysis set contains all subjects who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur.
    End point type
    Secondary
    End point timeframe
    Within 28 days after the third vaccination
    End point values
    FSME-IMMUN-Third Vaccination
    Number of subjects analysed
    298
    Units: subjects
        Systemic reactions: None
    282
        Systemic reactions: Mild
    15
        Systemic reactions: Moderate
    1
        Systemic reactions: Severe
    0
    No statistical analyses for this end point

    Secondary: Frequency and Severity of Injection Site Reactions Occuring After the First Vaccination

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    End point title
    Frequency and Severity of Injection Site Reactions Occuring After the First Vaccination
    End point description
    Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in subject diary. The safety analysis set contains all subjects who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur.
    End point type
    Secondary
    End point timeframe
    Within 6 days of first vaccination (Day 0 to Day 6)
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    150
    152
    Units: subjects
        None
    131
    108
        Unknown
    1
    0
        Mild
    18
    41
        Moderate
    0
    3
        Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Frequency and Severity of Injection Site Reactions Occuring After the Second Vaccination

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    End point title
    Frequency and Severity of Injection Site Reactions Occuring After the Second Vaccination
    End point description
    Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in subject diary. The safety analysis set contains all subjects who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur.
    End point type
    Secondary
    End point timeframe
    Within 6 days of second vaccination (Day 0 to Day 6)
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    150
    152
    Units: subjects
        None
    137
    118
        Mild
    12
    27
        Moderate
    1
    7
        Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Frequency and Severity of Injection Site Reactions Occuring After the Third Vaccination

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    End point title
    Frequency and Severity of Injection Site Reactions Occuring After the Third Vaccination
    End point description
    Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in subject diary. The safety analysis set contains all subjects who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur.
    End point type
    Secondary
    End point timeframe
    Within 6 days of third vaccination (Day 0 to Day 6)
    End point values
    FSME-IMMUN-Third Vaccination
    Number of subjects analysed
    298
    Units: subjects
        None
    249
        Mild
    43
        Moderate
    4
        Severe
    2
    No statistical analyses for this end point

    Secondary: Frequency and Severity of Adverse Events (AE) Observed Before the Third Vaccination

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    End point title
    Frequency and Severity of Adverse Events (AE) Observed Before the Third Vaccination
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE (serious AE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­-threatening experience (immediate risk of dying); persistent or significant disability / incapacity; congenital anomaly. Treatment­-emergent are events between first dose of study drug and up to one month after last dose that were absent before treatment or that worsened relative to pre-treatment state. The safety analysis set contains all subjects who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur.
    End point type
    Secondary
    End point timeframe
    Within 28 days after first and second vaccination, after Part A to before the third vaccination
    End point values
    FSME-IMMUN Encepur
    Number of subjects analysed
    150
    152
    Units: subjects
        Non-Serious AE: within 28 days after Vaccination 1
    57
    80
        Serious AE: within 28 days after Vaccination 1
    1
    0
        Non-Serious AE: within 28 days after Vaccination 2
    42
    66
        Serious AE: within 28 days after Vaccination 2
    0
    0
        Non-Serious AE:after Part A to before Vaccination3
    97
    102
        Serious AE: after Part A to before Vaccination 3
    6
    10
    No statistical analyses for this end point

    Secondary: Frequency and Severity of Adverse Events (AE) Observed After the Third Vaccination

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    End point title
    Frequency and Severity of Adverse Events (AE) Observed After the Third Vaccination
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE (serious AE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability / incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to one month after last dose that were absent before treatment or that worsened relative to pre-treatment state. The safety analysis set contains all subjects who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur.
    End point type
    Secondary
    End point timeframe
    Within 28 days after third vaccination
    End point values
    FSME-IMMUN-Third Vaccination
    Number of subjects analysed
    298
    Units: subjects
        Non-Serious AE: within 28 days after Vaccination 3
    102
        Serious AE: within 28 days after Vaccination 3
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 28 days after first and second vaccination, after Part A to before the third vaccination, within 28 days after third vaccination
    Adverse event reporting additional description
    SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in subject diary (local and systemic reactions for FSME-IMMUN) and AEs were documented in subject diary (non­systematic assessment).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Part A (1-2 years of age) FSME-IMMUN: After Vaccination 1
    Reporting group description
    Subjects aged 1 - 2 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0, assessed after first vaccination.

    Reporting group title
    Part A (1-2 years of age) FSME-IMMUN: After Vaccination 2
    Reporting group description
    Subjects aged 1 - 2 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 28, assessed after second vaccination.

    Reporting group title
    Part B (1-2 years of age) FSME-IMMUN: Before Vaccination 3
    Reporting group description
    Subjects aged 1 - 2 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.

    Reporting group title
    Part A (3-6 years of age) FSME-IMMUN: After Vaccination 1
    Reporting group description
    Subjects aged 3 - 6 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0, assessed after first vaccination.

    Reporting group title
    Part A (3-6 years of age) FSME-IMMUN: After Vaccination 2
    Reporting group description
    Subjects aged 3 - 6 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 28, assessed after second vaccination.

    Reporting group title
    Part B (3-6 years of age) FSME-IMMUN: Before Vaccination 3
    Reporting group description
    Subjects aged 3 - 6 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.

    Reporting group title
    Part A (7-11 years of age) FSME-IMMUN: After Vaccination 1
    Reporting group description
    Subjects aged 7 - 11 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0, assessed after first vaccination.

    Reporting group title
    Part A (7-11 years of age) FSME-IMMUN: After Vaccination 2
    Reporting group description
    Subjects aged 7 - 11 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 28, assessed after second vaccination.

    Reporting group title
    Part B (7-11 years of age) FSME-IMMUN: Before Vaccination 3
    Reporting group description
    Subjects aged 7 - 11 years who received single dose of 0.25 mL FSME-IMMUN Junior (FSME-IMMUN) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.

    Reporting group title
    Part A (1-2 years of age) Encepur: After Vaccination 1
    Reporting group description
    Subjects aged 1 - 2 years who received single dose of Encepur Children (Encepur) suspension at Day 0, assessed after first vaccination.

    Reporting group title
    Part A (1-2 years of age) Encepur: After Vaccination 2
    Reporting group description
    Subjects aged 1 - 2 years who received single dose of Encepur Children (Encepur) suspension at Day 28, assessed after second vaccination.

    Reporting group title
    Part B (1-2 years of age) Encepur: Before Vaccination 3
    Reporting group description
    Subjects aged 1 - 2 years who received single dose of Encepur Children (Encepur) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.

    Reporting group title
    Part A (3-6 years of age) Encepur: After Vaccination 1
    Reporting group description
    Subjects aged 3 - 6 years who received single dose of Encepur Children (Encepur) suspension at Day 0, assessed after first vaccination.

    Reporting group title
    Part A (3-6 years of age) Encepur: After Vaccination 2
    Reporting group description
    Subjects aged 3 - 6 years who received single dose of Encepur Children (Encepur) suspension at Day 28, assessed after second vaccination.

    Reporting group title
    Part B (3-6 years of age) Encepur: Before Vaccination 3
    Reporting group description
    Subjects aged 3 - 6 years who received single dose of Encepur Children (Encepur) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.

    Reporting group title
    Part A (7-11 years of age) Encepur: After Vaccination 1
    Reporting group description
    Subjects aged 7 - 11 years who received single dose of Encepur Children (Encepur) suspension at Day 0, assessed after first vaccination.

    Reporting group title
    Part A (7-11 years of age) Encepur: After Vaccination 2
    Reporting group description
    Subjects aged 7 - 11 years who received single dose of Encepur Children (Encepur) suspension at Day 28, assessed after second vaccination.

    Reporting group title
    Part B (7-11 years of age) Encepur: Before Vaccination 3
    Reporting group description
    Subjects aged 7 - 11 years who received single dose of Encepur Children (Encepur) suspension at Day 0 and 28, assessed 28 Days after the second vaccination to prior to third vaccination.

    Reporting group title
    Part B (1-2 years of age) FSME-IMMUN: After Vaccination 3
    Reporting group description
    Subjects aged 1 - 2 years who received either FSME-IMMUN or Encepur during the first and second vaccination, received FSME­IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination. Assessment of AEs was done after the third vaccination.

    Reporting group title
    Part B (3-6 years of age) FSME-IMMUN: After Vaccination 3
    Reporting group description
    Subjects aged 3 - 6 years who received either FSME-IMMUN or Encepur during the first and second vaccination, received FSME​-IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination. Assessment of AEs was done after the third vaccination.

    Reporting group title
    Part B (7-11 years of age) FSME-IMMUN: After Vaccination 3
    Reporting group description
    Subjects aged 7 - 11 years who received either FSME-IMMUN or Encepur during the first and second vaccination, received FSME-​IMMUN Junior (FSME-IMMUN) at Day 360 as third vaccination. Assessment of AEs was done after the third vaccination.

    Serious adverse events
    Part A (1-2 years of age) FSME-IMMUN: After Vaccination 1 Part A (1-2 years of age) FSME-IMMUN: After Vaccination 2 Part B (1-2 years of age) FSME-IMMUN: Before Vaccination 3 Part A (3-6 years of age) FSME-IMMUN: After Vaccination 1 Part A (3-6 years of age) FSME-IMMUN: After Vaccination 2 Part B (3-6 years of age) FSME-IMMUN: Before Vaccination 3 Part A (7-11 years of age) FSME-IMMUN: After Vaccination 1 Part A (7-11 years of age) FSME-IMMUN: After Vaccination 2 Part B (7-11 years of age) FSME-IMMUN: Before Vaccination 3 Part A (1-2 years of age) Encepur: After Vaccination 1 Part A (1-2 years of age) Encepur: After Vaccination 2 Part B (1-2 years of age) Encepur: Before Vaccination 3 Part A (3-6 years of age) Encepur: After Vaccination 1 Part A (3-6 years of age) Encepur: After Vaccination 2 Part B (3-6 years of age) Encepur: Before Vaccination 3 Part A (7-11 years of age) Encepur: After Vaccination 1 Part A (7-11 years of age) Encepur: After Vaccination 2 Part B (7-11 years of age) Encepur: Before Vaccination 3 Part B (1-2 years of age) FSME-IMMUN: After Vaccination 3 Part B (3-6 years of age) FSME-IMMUN: After Vaccination 3 Part B (7-11 years of age) FSME-IMMUN: After Vaccination 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    2 / 48 (4.17%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    4 / 50 (8.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Foreign body
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic liver injury
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Orchidopexy
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hypospadias
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cryptorchism
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal disorder
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Eustachian tube disorder
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Part A (1-2 years of age) FSME-IMMUN: After Vaccination 1 Part A (1-2 years of age) FSME-IMMUN: After Vaccination 2 Part B (1-2 years of age) FSME-IMMUN: Before Vaccination 3 Part A (3-6 years of age) FSME-IMMUN: After Vaccination 1 Part A (3-6 years of age) FSME-IMMUN: After Vaccination 2 Part B (3-6 years of age) FSME-IMMUN: Before Vaccination 3 Part A (7-11 years of age) FSME-IMMUN: After Vaccination 1 Part A (7-11 years of age) FSME-IMMUN: After Vaccination 2 Part B (7-11 years of age) FSME-IMMUN: Before Vaccination 3 Part A (1-2 years of age) Encepur: After Vaccination 1 Part A (1-2 years of age) Encepur: After Vaccination 2 Part B (1-2 years of age) Encepur: Before Vaccination 3 Part A (3-6 years of age) Encepur: After Vaccination 1 Part A (3-6 years of age) Encepur: After Vaccination 2 Part B (3-6 years of age) Encepur: Before Vaccination 3 Part A (7-11 years of age) Encepur: After Vaccination 1 Part A (7-11 years of age) Encepur: After Vaccination 2 Part B (7-11 years of age) Encepur: Before Vaccination 3 Part B (1-2 years of age) FSME-IMMUN: After Vaccination 3 Part B (3-6 years of age) FSME-IMMUN: After Vaccination 3 Part B (7-11 years of age) FSME-IMMUN: After Vaccination 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 50 (34.00%)
    13 / 50 (26.00%)
    37 / 50 (74.00%)
    15 / 51 (29.41%)
    11 / 51 (21.57%)
    30 / 51 (58.82%)
    14 / 49 (28.57%)
    10 / 49 (20.41%)
    30 / 48 (62.50%)
    25 / 50 (50.00%)
    13 / 50 (26.00%)
    39 / 50 (78.00%)
    33 / 51 (64.71%)
    19 / 51 (37.25%)
    33 / 51 (64.71%)
    30 / 51 (58.82%)
    26 / 51 (50.98%)
    30 / 51 (58.82%)
    23 / 99 (23.23%)
    29 / 100 (29.00%)
    30 / 99 (30.30%)
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Allergic oedema
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Multiple allergies
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    4 / 51 (7.84%)
    3 / 51 (5.88%)
    3 / 51 (5.88%)
    4 / 49 (8.16%)
    1 / 49 (2.04%)
    5 / 48 (10.42%)
    9 / 50 (18.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    5 / 51 (9.80%)
    3 / 51 (5.88%)
    2 / 51 (3.92%)
    4 / 51 (7.84%)
    2 / 51 (3.92%)
    3 / 51 (5.88%)
    3 / 99 (3.03%)
    8 / 100 (8.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    6
    3
    3
    4
    2
    5
    9
    3
    0
    5
    4
    2
    5
    2
    4
    3
    8
    0
    Fatigue
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    3 / 49 (6.12%)
    2 / 49 (4.08%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 51 (5.88%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    3 / 99 (3.03%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    3
    2
    0
    0
    0
    0
    3
    1
    0
    2
    0
    0
    0
    1
    3
    Malaise
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    1
    Injection site erythema
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 51 (5.88%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    4 / 51 (7.84%)
    0 / 51 (0.00%)
    1 / 99 (1.01%)
    4 / 100 (4.00%)
    4 / 99 (4.04%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    1
    0
    0
    3
    0
    0
    3
    2
    0
    3
    4
    0
    1
    4
    4
    Injection site induration
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    2 / 49 (4.08%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 51 (5.88%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    4 / 51 (7.84%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    3 / 100 (3.00%)
    6 / 99 (6.06%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    1
    0
    3
    0
    0
    3
    3
    0
    4
    2
    0
    0
    3
    6
    Injection site pain
         subjects affected / exposed
    1 / 50 (2.00%)
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    3 / 51 (5.88%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    10 / 49 (20.41%)
    5 / 49 (10.20%)
    0 / 48 (0.00%)
    4 / 50 (8.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    10 / 51 (19.61%)
    6 / 51 (11.76%)
    0 / 51 (0.00%)
    24 / 51 (47.06%)
    24 / 51 (47.06%)
    0 / 51 (0.00%)
    2 / 99 (2.02%)
    13 / 100 (13.00%)
    27 / 99 (27.27%)
         occurrences all number
    1
    2
    0
    3
    4
    0
    15
    7
    0
    4
    1
    0
    13
    8
    0
    30
    30
    0
    2
    17
    38
    Injection site swelling
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    7 / 99 (7.07%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    3
    0
    0
    1
    7
    Injection site haematoma
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    3 / 99 (3.03%)
         occurrences all number
    1
    0
    0
    1
    2
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    2
    3
    0
    0
    1
    3
    Injection site haemorrhage
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tenderness
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    5 / 50 (10.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    0
    5
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    1
    1
    0
    1
    0
    0
    1
    0
    0
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Balanitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Acquired phimosis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    4
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Joint sprain
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Head injury
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    3
    0
    1
    1
    0
    0
    2
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Burns second degree
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Thermal burn
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Joint dislocation
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Mouth injury
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Clavicle fracture
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Forearm fracture
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ankle fracture
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Heat stroke
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Open wound
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Traumatic liver injury
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Investigations
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Heart rate increased
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Cryptorchism
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    Anaemia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Lymphadenitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    3 / 48 (6.25%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 51 (3.92%)
    3 / 51 (5.88%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    4
    1
    0
    0
    2
    3
    1
    0
    0
    2
    0
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Adenoidal disorder
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Asthma
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tracheal pain
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    4 / 51 (7.84%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    3 / 100 (3.00%)
    7 / 99 (7.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    4
    0
    0
    0
    1
    0
    3
    7
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Middle ear inflammation
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Enteritis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    4 / 50 (8.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    4
    1
    1
    0
    0
    0
    0
    1
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    0 / 48 (0.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    0
    0
    2
    1
    0
    2
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    3 / 49 (6.12%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    3 / 100 (3.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    3
    0
    0
    3
    0
    0
    3
    0
    0
    0
    1
    0
    0
    4
    1
    Toothache
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Enterocolitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Aphthous stomatitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Anal fissure
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Micturition disorder
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    2 / 99 (2.02%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    2
    Arthritis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Foot deformity
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Endocrine disorders
    Thyroiditis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    2 / 100 (2.00%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    0
    0
    2
    0
    0
    2
    1
    0
    1
    0
    0
    0
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Underweight
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Obesity
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    5 / 50 (10.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    4 / 51 (7.84%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    2 / 50 (4.00%)
    1 / 50 (2.00%)
    5 / 50 (10.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    4 / 51 (7.84%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    5
    1
    0
    4
    0
    0
    1
    2
    1
    7
    0
    0
    4
    0
    0
    2
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    4 / 50 (8.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
    3 / 48 (6.25%)
    2 / 50 (4.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    4 / 51 (7.84%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    4 / 51 (7.84%)
    0 / 99 (0.00%)
    2 / 100 (2.00%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    7
    1
    0
    1
    0
    1
    4
    2
    1
    0
    0
    2
    5
    1
    0
    5
    0
    2
    0
    Erythema infectiosum
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Laryngitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    3 / 50 (6.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    3 / 50 (6.00%)
    1 / 50 (2.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    0
    1
    4
    0
    0
    1
    0
    0
    0
    3
    1
    3
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Otitis media
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 50 (6.00%)
    8 / 50 (16.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
    0 / 48 (0.00%)
    5 / 50 (10.00%)
    1 / 50 (2.00%)
    8 / 50 (16.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    5 / 99 (5.05%)
    2 / 100 (2.00%)
    0 / 99 (0.00%)
         occurrences all number
    1
    3
    11
    1
    0
    0
    0
    0
    0
    5
    1
    10
    1
    1
    2
    0
    0
    0
    5
    2
    0
    Pharyngitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    3 / 49 (6.12%)
    0 / 49 (0.00%)
    9 / 48 (18.75%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    5 / 51 (9.80%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    5 / 51 (9.80%)
    0 / 99 (0.00%)
    6 / 100 (6.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    0
    0