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    Clinical Trial Results:
    An Efficacy and 2-Year Safety Study of Open-label Rosuvastatin in Children and Adolescents (aged from 6 to less than 18 years) with Familial Hypercholesterolaemia

    Summary
    EudraCT number
    		 2009-016492-29
    Trial protocol
    		 NL   BE   Outside EU/EEA  
    Global end of trial date
    08 Feb 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2016
    First version publication date
    08 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3561C00002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01078675
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca, R&D, B&I
    Sponsor organisation address
    Pepparedsleden 1, Molndal, Sweden, 431 83
    Public contact
    Robin Mukherjee, GPS, Biometrics and Information Sciences, robin.mukherjee@astrazeneca.com
    Scientific contact
    Robin Mukherjee, GPS, Biometrics and Information Sciences, robin.mukherjee@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000022-PIP01-07
    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
    25 Jun 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the study were: • To assess the efficacy of rosuvastatin in paediatric patients with FH. • To establish long-term safety, tolerability and efficacy of rosuvastatin in paediatric patients with FH. • To characterise the PK profile of rosuvastatin in paediatric patients, aged from 6 to less than Tanner Stage II, with FH.
    Protection of trial subjects
    An external consultant functioned as an independent safety monitor to assess safety data beginning 4 months after the first patient was enrolled into the trial and then approximately every 4 months until study completion.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Canada: 114
    Country: Number of subjects enrolled
    Netherlands: 126
    Country: Number of subjects enrolled
    Norway: 59
    Country: Number of subjects enrolled
    United States: 19
    Worldwide total number of subjects
    327
    EEA total number of subjects
    194
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    131
    Adolescents (12-17 years)
    196
    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
    		 250 patients with FH were screened. Additionally, 65 healthy siblings (HS) were enrolled. HS refers to healthy subjects that were siblings of either the study participants or other paediatric patients with HeFH that were not participating in the study. HS were enrolled to have assessments of cIMT, but did not participate further.

    Pre-assignment
    Screening details
    		 Statin-naïve patients including all patients aged 6 to <10 years, were qualified for by meeting all inclusion, exclusion and LDL-C criteria at Visit 1. Previously treated patients qualified by meeting all inclusion and exclusion criteria at screening Visits 1 and 2 and by meeting LDL-C criteria at Visit 2.

    Period 1
    Period 1 title
    Visit 3
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rosuvastatin
    Arm description
    		 Rosuvastatin 5 mg, 10 mg or 20 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rosuvastatin, Crestor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 to 20 mg

    Arm title
    		 Single Dose PK
    Arm description
    		 -
    Arm type
    		 Modified Intention to Treat

    Investigational medicinal product name
    Rosuvastatin, Crestor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg

    Arm title
    		 Healthy Siblings
    Arm description
    		 -
    Arm type
    		 Modified Intention to Treat

    Investigational medicinal product name
    Control
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Control

    Number of subjects in period 1
    		Rosuvastatin Single Dose PK Healthy Siblings
    Started
    250
    12
    65
    Completed
    250
    12
    65
    Period 2
    Period 2 title
    Overall Study
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Rosuvastatin
    Arm description
    		 Rosuvastatin 5 mg, 10 mg or 20 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rosuvastatin, Crestor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 to 20 mg

    Arm title
    		 Single Dose PK
    Arm description
    		 -
    Arm type
    		 Modified Intention to Treat

    Investigational medicinal product name
    Rosuvastatin, Crestor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg

    Arm title
    		 Healthy Siblings
    Arm description
    		 -
    Arm type
    		 Modified Intention to Treat

    Investigational medicinal product name
    Control
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Control

    Number of subjects in period 2
    		Rosuvastatin Single Dose PK Healthy Siblings
    Started
    250
    12
    65
    Patients treated
    198
    12
    65
    Completed
    182
    12
    65
    Not completed
    68
    0
    0
         Consent withdrawn by subject
    7
    -
    -
         Adverse event, non-fatal
    3
    -
    -
         Provided in CRF for specific reasons
    2
    -
    -
         Protocol deviation
    56
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rosuvastatin
    Reporting group description
    		 Rosuvastatin 5 mg, 10 mg or 20 mg

    Reporting group title
    Single Dose PK
    Reporting group description
    		 -

    Reporting group title
    Healthy Siblings
    Reporting group description
    		 -

    Reporting group values
    		 Rosuvastatin Single Dose PK Healthy Siblings Total
    Number of subjects
    		 250 12 65 327
    Age categorical
    Units: Subjects
        6-<10
    		 70 12 21 103
        10-<14
    		 96 0 22 118
        14-<18
    		 84 0 22 106
    Age Continuous | Years
    Units: Years
        arithmetic mean (standard deviation)
    		 11.8 ± 3.2 8 ± 0.9 11.5 ± 3.5 -
    Gender, Male/Female
    Units: Participants
        Female
    		 127 7 32 166
        Male
    		 123 5 33 161
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 220 12 53 285
        non-Caucasian
    		 30 0 12 42
    Subject analysis sets

    Subject analysis set title
    Healthy Siblings
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Controls to HeFH patients in the cIMT evaluations

    Subject analysis set title
    Single dose PK
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Rosuvastatin 10 mg

    Subject analysis set title
    ITT Baseline
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Including patients who took atleast 1 dose of study medication and had a baseline and at least 1 LDL-C measured in a subsequent visit.

    Subject analysis set title
    ITT 24 month
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Including patients who took atleast 1 dose of study medication and had a baseline and at least 1 LDL-C measured in a subsequent visit.

    Subject analysis sets values
    		 Healthy Siblings Single dose PK ITT Baseline ITT 24 month
    Number of subjects
    65
    12
    197
    197
    Age categorical
    Units: Subjects
        6-<10
    21
    12
    63
    63
        10-<14
    22
    0
    72
    72
        14-<18
    22
    0
    62
    62
    Age Continuous | Years
    Units: Years
        arithmetic mean (standard deviation)
    11.5 ± 3.5
    8 ± 0.9
    11.6 ± 3.3
    13.6 ± 3.3
    Gender, Male/Female
    Units: Participants
        Female
    32
    7
    110
    110
        Male
    33
    5
    87
    87
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    53
    12
    177
    177
        non-Caucasian
    12
    0
    20
    20

    End points

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    End points reporting groups
    Reporting group title
    Rosuvastatin
    Reporting group description
    		 Rosuvastatin 5 mg, 10 mg or 20 mg

    Reporting group title
    Single Dose PK
    Reporting group description
    		 -

    Reporting group title
    Healthy Siblings
    Reporting group description
    		 -
    Reporting group title
    Rosuvastatin
    Reporting group description
    		 Rosuvastatin 5 mg, 10 mg or 20 mg

    Reporting group title
    Single Dose PK
    Reporting group description
    		 -

    Reporting group title
    Healthy Siblings
    Reporting group description
    		 -

    Subject analysis set title
    Healthy Siblings
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Controls to HeFH patients in the cIMT evaluations

    Subject analysis set title
    Single dose PK
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Rosuvastatin 10 mg

    Subject analysis set title
    ITT Baseline
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Including patients who took atleast 1 dose of study medication and had a baseline and at least 1 LDL-C measured in a subsequent visit.

    Subject analysis set title
    ITT 24 month
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Including patients who took atleast 1 dose of study medication and had a baseline and at least 1 LDL-C measured in a subsequent visit.

    Primary: Percent Change from Baseline in LDL-C

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    End point title
    		 Percent Change from Baseline in LDL-C
    End point description
    Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
    End point type
    Primary
    End point timeframe
    At Month 3, Month 12 and Month 24
    End point values
    		 Rosuvastatin ITT Baseline ITT 24 month
    Number of subjects analysed
    197
    197
    197
    Units: Percentage change
    arithmetic mean (standard deviation)
        LDL-C %Change from Baseline at month 3
    -37.86 ± 14.392
    0 ± 0
    -37.86 ± 14.392
        LDL-C %Change from Baseline at month 12
    -43.67 ± 14.896
    0 ± 0
    -43.67 ± 14.896
        LDL-C %Change from Baseline at month 24
    -42.88 ± 18.222
    0 ± 0
    -42.88 ± 18.222
    Statistical analysis title
    		 Percent Change from Baseline in LDL Cholesterol
    Comparison groups
    Rosuvastatin v ITT 24 month v ITT Baseline
    Number of subjects included in analysis
    591
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 LS Means
    Point estimate
    -42.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.44
         upper limit
    		 -40.32
    Variability estimate
    Standard deviation
    Dispersion value
    18.222
    Notes
    [1] - The p-value is actually less than 0.001

    Secondary: Sexual Maturation by Tanner Staging at baseline

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    End point title
    		 Sexual Maturation by Tanner Staging at baseline
    End point description
    Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
    End point type
    Secondary
    End point timeframe
    At Baseline
    End point values
    		 Rosuvastatin
    Number of subjects analysed
    197
    Units: Participants
        Tanner Stage I at Baseline
    81
        Tanner Stage II at Baseline
    32
        Tanner Stage III at Baseline
    18
        Tanner Stage IV at Baseline
    44
        Tanner Stage V at Baseline
    21
        Not Recorded at Baseline
    1
    No statistical analyses for this end point

    Secondary: Single Dose PK - Cmax

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    End point title
    		 Single Dose PK - Cmax
    End point description
    Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
    End point type
    Secondary
    End point timeframe
    Serial blood samples over 24 hours.
    End point values
    		 Single Dose PK Single dose PK
    Number of subjects analysed
    12
    12
    Units: ng/mL
        arithmetic mean (standard deviation)
    3.5717 ± 3.2235
    3.5717 ± 3.2235
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in HDL-C, TC, TG, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1

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    End point title
    		 Percent Change from Baseline in HDL-C, TC, TG, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1
    End point description
    One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 12 and Month 24
    End point values
    		 Rosuvastatin
    Number of subjects analysed
    197
    Units: Percent change
    arithmetic mean (standard deviation)
        HDL-C %Change from Baseline at Month 3
    5.67 ± 17.445
        HDL-C %Change from Baseline at Month 12
    6.35 ± 16.725
        HDL-C %Change from Baseline at Month 24
    11.73 ± 19.996
        TC %Change from Baseline at Month 3
    -29.6 ± 11.433
        TC %Change from Baseline at Month 12
    -33.91 ± 12.05
        TC %Change from Baseline at Month 24
    -32.03 ± 14.53
        Triglycerides %Change from Baseline at Month 3
    -7.95 ± 34.482
        Triglycerides %Change from Baseline at Month 12
    -7.85 ± 37.53
        Triglycerides %Change from Baseline at Month 24
    -0.12 ± 37.682
        non-HDL C %Change from Baseline at Month 3
    -36.35 ± 13.368
        non-HDL C %Change from Baseline at Month 12
    -41.66 ± 14.235
        non-HDL C %Change from Baseline at Month 24
    -40.4 ± 17.555
        LDL-C/HDL-C %Change from Baseline at Month 3
    -39.66 ± 17.381
        LDL-C/HDL-C %Change from Baseline at Month 12
    -45.63 ± 17.082
        LDL-C/HDL-C %Change from Baseline at Month 24
    -46.95 ± 20.126
        TC/HDL-C %Change from Baseline at Month 3
    -31.77 ± 14.874
        TC/HDL-C %Change from Baseline at Month 12
    -36.54 ± 14.474
        TC/HDL-C %Change from Baseline at Month 24
    -37.39 ± 17.079
        Trig/HDL-C %Change from Baseline at Month 3
    -9.05 ± 41.765
        Trig/HDL-C %Change from Baseline at Month 12
    -10.5 ± 40.633
        Trig/HDL-C %Change from Baseline at Month 24
    -7.12 ± 40.585
        non-HDL-C/HDL-C %Change from Baseline at Month 3
    -37.98 ± 17.369
        non-HDL-C/HDL-C %Change from Baseline at Month 12
    -43.71 ± 16.731
        non-HDL-C/HDL-C %Change from Baseline at Month 24
    -44.74 ± 19.896
        ApoA-I %Change from Baseline at Month 3
    4.77 ± 14.68
        ApoA-I %Change from Baseline at Month 12
    1.41 ± 13.747
        ApoA-I %Change from Baseline at Month 24
    2.34 ± 15.027
        ApoB %Change from Baseline at Month 3
    -29.29 ± 12.456
        ApoB %Change from Baseline at Month 12
    -35.65 ± 12.424
        ApoB %Change from Baseline at Month 24
    -35.72 ± 15.71
        ApoB/ApoA-I %Change from Baseline at Month 3
    -31.3 ± 15.524
        ApoB/ApoA-I %Change from Baseline at Month 12
    -35.66 ± 13.92
        ApoB/ApoA-I %Change from Baseline at Month 24
    -35.94 ± 18.743
        hsCRP %Change from Baseline at Month 3
    512.57 ± 4724.249
        hsCRP %Change from Baseline at Month 12
    42.96 ± 226.954
        hsCRP %Change from Baseline at Month 24
    98.36 ± 565.444
    No statistical analyses for this end point

    Secondary: Change from Baseline in Max and Mean carotid intima and media wall thickness (cIMT)

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    End point title
    		 Change from Baseline in Max and Mean carotid intima and media wall thickness (cIMT)
    End point description
    One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
    End point type
    Secondary
    End point timeframe
    At Month 12 and Month 24
    End point values
    		 Rosuvastatin Healthy Siblings
    Number of subjects analysed
    197
    64
    Units: mm
    arithmetic mean (standard deviation)
        Max cIMT Change from Baseline at Month 12
    0.00626 ± 0.073446
    0.01707 ± 0.056223
        Max cIMT Change from Baseline at Month 24
    0.00189 ± 0.060864
    0.01202 ± 0.049102
        Mean cIMT Change from Baseline at Month 12
    0.00282 ± 0.041186
    0.01564 ± 0.032052
        Mean cIMT Change from Baseline at Month 24
    0.01056 ± 0.040762
    0.02779 ± 0.031004
    No statistical analyses for this end point

    Secondary: Adverse Events

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    End point title
    		 Adverse Events
    End point description
    Number of participants with Various Categories of AE's. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
    End point type
    Secondary
    End point timeframe
    2-year study period
    End point values
    		 Rosuvastatin
    Number of subjects analysed
    197
    Units: Participant
        Any AE
    172
        AE Leading to Death
    0
        AE Leading to Discontinuation
    3
        Serious AE
    9
        Treatment Related AE
    29
        Treatment Related AE Leading to Death
    0
        Treatment Related AE Leading to Discontinuation
    3
        Treatment Related Serious AE
    0
    No statistical analyses for this end point

    Secondary: Total duration of exposure

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    End point title
    		 Total duration of exposure
    End point description
    Total duration of exposure was calculated as [last dose date of rosuva - first dose date of rosuva + 1 day]. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
    End point type
    Secondary
    End point timeframe
    2-year study period
    End point values
    		 Rosuvastatin
    Number of subjects analysed
    197
    Units: Days
        arithmetic mean (standard deviation)
    703.5 ± 97.25
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Height

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    End point title
    		 Percent Change from Baseline in Height
    End point description
    One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
    End point type
    Secondary
    End point timeframe
    At Month 12 and Month 24
    End point values
    		 Rosuvastatin
    Number of subjects analysed
    197
    Units: Percent change
    arithmetic mean (standard deviation)
        %Change from Baseline at Month 12
    3.2 ± 2.023
        %Change from Baseline at Month 24
    5.91 ± 3.968
    No statistical analyses for this end point

    Secondary: Sexual Maturation by Tanner Staging at month 12

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    End point title
    		 Sexual Maturation by Tanner Staging at month 12
    End point description
    Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
    End point type
    Secondary
    End point timeframe
    At Baseline
    End point values
    		 Rosuvastatin
    Number of subjects analysed
    197
    Units: Participants
        Tanner Stage I at Month 12
    61
        Tanner Stage II at Month 12
    31
        Tanner Stage III at Month 12
    21
        Tanner Stage IV at Month 12
    32
        Tanner Stage V at Month 12
    42
        Not Recorded at Month 12
    10
    No statistical analyses for this end point

    Secondary: Sexual Maturation by Tanner Staging at month 24

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    End point title
    		 Sexual Maturation by Tanner Staging at month 24
    End point description
    Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
    End point type
    Secondary
    End point timeframe
    At Baseline
    End point values
    		 Rosuvastatin
    Number of subjects analysed
    197
    Units: Participants
        Tanner Stage I at Month 24
    43
        Tanner Stage II at Month 24
    33
        Tanner Stage III at Month 24
    23
        Tanner Stage IV at Month 24
    32
        Tanner Stage V at Month 24
    64
        Not Recorded at Month 24
    2
    No statistical analyses for this end point

    Secondary: Single Dose PK - Tmax

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    End point title
    		 Single Dose PK - Tmax
    End point description
    Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
    End point type
    Secondary
    End point timeframe
    Serial blood samples over 24 hours
    End point values
    		 Single dose PK
    Number of subjects analysed
    12
    Units: hr
        arithmetic mean (standard deviation)
    2.664 ± 1.8851
    No statistical analyses for this end point

    Secondary: Single Dose PK - AUC(0-24)

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    End point title
    		 Single Dose PK - AUC(0-24)
    End point description
    Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
    End point type
    Secondary
    End point timeframe
    Serial blood samples over 24 hours
    End point values
    		 Single dose PK
    Number of subjects analysed
    12
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    27.675 ± 26.6417
    No statistical analyses for this end point

    Secondary: Overal treatment adherence

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    End point title
    		 Overal treatment adherence
    End point description
    Overall adherence rate was calculated as the weighted mean of adherence rates of all consecutive visits after baseline, in which the adherence rate between 2 consecutive visits was a percentage of the number of rosuvastatin taken divided by duration of exposure. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
    End point type
    Secondary
    End point timeframe
    2-year study period
    End point values
    		 Rosuvastatin
    Number of subjects analysed
    197
    Units: Percent of doses
        arithmetic mean (standard deviation)
    89.6 ± 12.25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment Phase
    Adverse event reporting additional description
    One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Rosuvastatin
    Reporting group description
    		 Rosuvastatin 5 mg, 10 mg or 20 mg

    Serious adverse events
    		 Rosuvastatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 197 (4.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Urinary retention postoperative
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple fractures
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Leg fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Pectus carinatum
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Epilepsy
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Streptococcal toxic shock syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral pericarditis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 Rosuvastatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    172 / 197 (87.31%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Vascular disorders
    Haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 197 (3.55%)
         occurrences all number
    8
    Influenza like illness
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 197 (8.12%)
         occurrences all number
    19
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 197 (5.08%)
         occurrences all number
    10
    Immune system disorders
    Allergy to animal
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Hypersensitivity
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    4
    Seasonal allergy
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    4
    Reproductive system and breast disorders
    Amenorrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Dysmenorrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Menstrual disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Menstruation irregular
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Polycystic ovaries
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Scrotal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 197 (5.58%)
         occurrences all number
    11
    Epistaxis
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 197 (3.05%)
         occurrences all number
    9
    Nasal congestion
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    3
    Nasal obstruction
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Oropharyngeal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 197 (6.60%)
         occurrences all number
    13
    Rhinorrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 197 (2.54%)
         occurrences all number
    5
    Sinus disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Sinus congestion
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    4
    Psychiatric disorders
    Attention deficit/hyperactivity disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Depressed mood
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Autism spectrum disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Depression
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Insomnia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Intentional self-injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Sleep disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Investigations
    Blood bilirubin increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    5
    Cardiac murmur
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Haemoglobin decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Hepatic enzyme increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    2
    Lymphocyte count abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Renal bruit
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Weight decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Serum ferritin decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Arthropod bite
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Concussion
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Contusion
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Excoriation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    2
    Face injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Fall
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    4
    Femur fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Foot fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Forearm fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Hand fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Joint injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Laceration
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Ligament rupture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Ligament sprain
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 197 (2.54%)
         occurrences all number
    5
    Limb injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Lower limb fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Multiple fractures
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    2
    Muscle strain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Periorbital haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Post procedural complication
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Post procedural swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Post-traumatic pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Procedural pain
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Road traffic accident
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Scratch
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Tendon rupture
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Tendon injury
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Traumatic haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Urinary retention postoperative
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Wrist fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Congenital, familial and genetic disorders
    Pectus carinatum
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    2
    Nervous system disorders
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 197 (3.05%)
         occurrences all number
    8
    Epilepsy
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    4
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    46 / 197 (23.35%)
         occurrences all number
    76
    Migraine
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    11
    Paraesthesia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Post-traumatic headache
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Presyncope
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Psychomotor hyperactivity
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Syncope
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 197 (3.05%)
         occurrences all number
    11
    Blood and lymphatic system disorders
    Lymphadenopathy
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Auricular swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Deafness unilateral
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Ear discomfort
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Ear pain
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Middle ear effusion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Motion sickness
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Eye disorders
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Myopia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Optic nerve disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Abdominal distension
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 197 (6.60%)
         occurrences all number
    18
    Abdominal pain upper
    alternative assessment type: Systematic
         subjects affected / exposed
    15 / 197 (7.61%)
         occurrences all number
    21
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    4
    Dental discomfort
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 197 (3.05%)
         occurrences all number
    9
    Dyspepsia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    4
    Flatulence
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Gastritis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    6
    Intestinal obstruction
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Mouth ulceration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Irritable bowel syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 197 (9.14%)
         occurrences all number
    24
    Toothache
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    4
    Rectal spasm
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 197 (9.64%)
         occurrences all number
    24
    Hepatobiliary disorders
    Hepatic pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 197 (3.05%)
         occurrences all number
    8
    Eczema
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    4
    Alopecia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Pruritus
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Nail disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Rash vesicular
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Skin lesion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Xanthoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Renal and urinary disorders
    Haematuria
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Pollakiuria
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Polyuria
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    2
    Pyuria
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Endocrine disorders
    Early menarche
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Hypothyroidism
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 197 (6.09%)
         occurrences all number
    15
    Back pain
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 197 (3.05%)
         occurrences all number
    6
    Bone disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Exostosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Flank pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Growing pains
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    4
    Joint stiffness
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Joint swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Muscular weakness
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Muscle spasms
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Musculoskeletal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    4
    Musculoskeletal stiffness
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    5
    Neck pain
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 197 (5.58%)
         occurrences all number
    12
    Osteochondrosis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Pain in extremity
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 197 (3.55%)
         occurrences all number
    7
    Pain in jaw
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Scoliosis
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Tendon disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Tendon pain
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    4
    Tendonitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Infections and infestations
    Amoebic dysentery
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Appendicitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Conjunctivitis infective
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Cystitis
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    5
    Ear infection
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    5
    Furuncle
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Eye infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Gastritis viral
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 197 (6.09%)
         occurrences all number
    15
    Gastroenteritis viral
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 197 (9.14%)
         occurrences all number
    24
    Gingival infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Groin infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Herpes zoster
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Impetigo
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Infectious mononucleosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Influenza
    alternative assessment type: Systematic
         subjects affected / exposed
    20 / 197 (10.15%)
         occurrences all number
    28
    Laryngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Lower respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Mononucleosis syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Nail infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    88 / 197 (44.67%)
         occurrences all number
    150
    Otitis externa
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Otitis media
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Pertussis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 197 (4.06%)
         occurrences all number
    10
    Pharyngitis streptococcal
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Pilonidal cyst
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Pyelonephritis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 197 (1.52%)
         occurrences all number
    3
    Rhinitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Sinusitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    4
    Tonsillitis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 197 (2.03%)
         occurrences all number
    6
    Tooth infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Toxic shock syndrome streptococcal
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 197 (5.58%)
         occurrences all number
    12
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 197 (3.55%)
         occurrences all number
    7
    Viral infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Viral pericarditis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    1
    Viral upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 197 (1.02%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hypoglycaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 197 (0.51%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2010
    Administrative changes/ updates
    21 May 2010
    Administrative changes/ updates
    08 Dec 2010
    Administrative changes/ updates
    06 Apr 2011
    Additional safety assessment required by US IRB

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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