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    Clinical Trial Results:
    Open-label multi-center study of magnetic resonance imaging (MRI) with 0.1 mmol/kg BW Gadovist (1.0 M) to assess pharmacokinetics, safety and tolerability in children

    Summary
    EudraCT number
    		 2006-004153-22
    Trial protocol
    		 DE   SE   DK   AT  
    Global end of trial date
    16 Apr 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Jul 2016
    First version publication date
    04 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Review of results set after re-introduction of EudraCT

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY86-4875/91552
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00468819
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Study number: 310788
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000994-PIP01-10
    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
    16 Apr 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate pharmacokinetic (PK) parameters of Gadovist in plasma at the standard dose of 0.1 millimoles per kilogram (mmol/kg) body weight (BW) in children of different age.
    Protection of trial subjects
    The planning and conduct of this clinical study was subject to national laws. Only when all of the requirements of the appropriate regulatory authority had been fulfilled was the study to begin. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization (ICH)-Good Clinical Practice Guideline of 17 January 1997 and guidance dedicated to performance of clinical trials in children (ICH-E11) was also taken into account. For minors, consent was given by the parent(s) or legal guardian(s). The consent of a minor was also requested where such a person was able to do so. His / her refusal or the withdrawal of his / her consent was not disregarded. Adolescents 14 years or older were required to document their assent either on a separate form specifically made for children or on the parents‘ consent form. Younger children could document their assent whenever feasible (at the discretion of the investigator/pediatrician).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 May 2007
    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
    Austria: 6
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    Canada: 10
    Country: Number of subjects enrolled
    Germany: 114
    Worldwide total number of subjects
    138
    EEA total number of subjects
    128
    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)
    90
    Adolescents (12-17 years)
    48
    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
    		 A total of 140 pediatric subjects aged 2 to less than 18 years, scheduled to undergo a routine contrast-enhanced magnetic resonance imaging (MRI) examination were screened and enrolled in 14 recruiting centers in 4 countries: Austria (1 center), Canada (2 centers), Germany (8 centers), and Sweden (3 centers).

    Pre-assignment
    Screening details
    		 Of 140 screened subjects, a total of 138 subjects were treated with study drug and completed the administration of the study drug according to protocol.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Gadobutrol - Age 2 to 6 Years
    Arm description
    		 Subjects in the age range of 2 to 6 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 milliliter per kilogram (mL/kg) BW as single intravenous bolus injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadobutrol
    Investigational medicinal product code
    BAY86-4875
    Other name
    Gadavist, Gadovist
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Subjects received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Arm title
    		 Gadobutrol - Age 7 to 11 Years
    Arm description
    		 Subjects in the age range of 7 to 11 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadobutrol
    Investigational medicinal product code
    BAY86-4875
    Other name
    Gadavist, Gadovist
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Arm title
    		 Gadobutrol - Age 12 to 17 Years
    Arm description
    		 Subjects in the age range of 12 to 17 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadobutrol
    Investigational medicinal product code
    BAY86-4875
    Other name
    Gadavist, Gadovist
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Arm title
    		 Gadobutrol - Age 2 to 17 Years
    Arm description
    		 Subjects received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection. This reporting group consists of the overall study population aged 2 to 17 years which is the sum of all the above 3 reporting groups ("Gadobutrol - Age 2 to 6 Years"+"Gadobutrol - Age 7 to 11 Years"+"Gadobutrol - Age 12 to 17 years").
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadobutrol
    Investigational medicinal product code
    BAY86-4875
    Other name
    Gadavist, Gadovist
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Number of subjects in period 1
    		Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Started
    46
    44
    48
    138
    Completed
    42
    44
    46
    132
    Not completed
    4
    0
    2
    6
         Consent withdrawn by subject
    4
    -
    1
    5
         Lost to follow-up
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gadobutrol - Age 2 to 6 Years
    Reporting group description
    		 Subjects in the age range of 2 to 6 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 milliliter per kilogram (mL/kg) BW as single intravenous bolus injection.

    Reporting group title
    Gadobutrol - Age 7 to 11 Years
    Reporting group description
    		 Subjects in the age range of 7 to 11 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Reporting group title
    Gadobutrol - Age 12 to 17 Years
    Reporting group description
    		 Subjects in the age range of 12 to 17 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Reporting group title
    Gadobutrol - Age 2 to 17 Years
    Reporting group description
    		 Subjects received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection. This reporting group consists of the overall study population aged 2 to 17 years which is the sum of all the above 3 reporting groups ("Gadobutrol - Age 2 to 6 Years"+"Gadobutrol - Age 7 to 11 Years"+"Gadobutrol - Age 12 to 17 years").

    Reporting group values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years Total
    Number of subjects
    		 46 44 48 138
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 3.7 ( 1.46 ) 9 ( 1.38 ) 14.7 ( 1.8 ) 9.2 ( 4.83 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 13 23 53 53
        Male
    		 29 31 25 85 85
    Body Weight
    Units: kilogram
        arithmetic mean (standard deviation)
    		 17.49 ( 5.434 ) 57.19 ( 14.245 ) 33.75 ( 8.956 ) 36.48 ( 19.447 ) -

    End points

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    End points reporting groups
    Reporting group title
    Gadobutrol - Age 2 to 6 Years
    Reporting group description
    		 Subjects in the age range of 2 to 6 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 milliliter per kilogram (mL/kg) BW as single intravenous bolus injection.

    Reporting group title
    Gadobutrol - Age 7 to 11 Years
    Reporting group description
    		 Subjects in the age range of 7 to 11 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Reporting group title
    Gadobutrol - Age 12 to 17 Years
    Reporting group description
    		 Subjects in the age range of 12 to 17 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Reporting group title
    Gadobutrol - Age 2 to 17 Years
    Reporting group description
    		 Subjects received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection. This reporting group consists of the overall study population aged 2 to 17 years which is the sum of all the above 3 reporting groups ("Gadobutrol - Age 2 to 6 Years"+"Gadobutrol - Age 7 to 11 Years"+"Gadobutrol - Age 12 to 17 years").

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS (number of subjects=138) included all subjects who received any amount of the investigational product.

    Subject analysis set title
    Final Pharmacokinetic (PK) analysis set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The pharmacokinetic analysis was performed based on the per protocol set (PPS). The PPS (number of subjects=135) consisted of all subjects who completed the necessary study procedures for determination of pharmacokinetic variables, who received the appropriate dose of Gadovist, and who had no major protocol deviations. Based on the results of gadolinium concentration measurement, additional 5 patients had to be excluded from PPS due to major deviations relevant for PK analysis. Therefore, a final PK analysis set was defined with a total of 130 subjects.

    Subject analysis set title
    Urinary analysis set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Urinary analysis set (number of subjects=97) included all subjects those valid for urinary analysis.

    Primary: Plasma Clearance Estimates of Gadobutrol by Age Group

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    End point title
    		 Plasma Clearance Estimates of Gadobutrol by Age Group [1]
    End point description
    Total body clearance of Gadobutrol in plasma in Liter per hour (L/h) after intravenous injection.
    End point type
    Primary
    End point timeframe
    From injection of Gadobutrol up to 8 hours after injection.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed since as planned all continuous and ordinal categorical variables were analyzed by descriptive statistics only.
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    45 [2]
    39 [3]
    46 [4]
    130 [5]
    Units: L/h
        median (inter-quartile range (Q1-Q3))
    2.07 (1.45 to 3.83)
    3.28 (1.81 to 5.93)
    4.9 (2.52 to 7.37)
    3.24 (1.53 to 6.62)
    Notes
    [2] - Final PK analysis set.
    [3] - Final PK analysis set.
    [4] - Final PK analysis set.
    [5] - Final PK analysis set.
    No statistical analyses for this end point

    Primary: Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group

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    End point title
    		 Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group [6]
    End point description
    Total body clearance of Gadobutrol in plasma corrected for body weight liter per hour per kilogram (L/h/kg) after intravenous injection.
    End point type
    Primary
    End point timeframe
    From injection up to 8 hours after Gadobutrol injection
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed since as planned all continuous and ordinal categorical variables were analyzed by descriptive statistics only.
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    45 [7]
    39 [8]
    46 [9]
    130 [10]
    Units: L/h/kg
        median (inter-quartile range (Q1-Q3))
    0.13 (0.09 to 0.17)
    0.1 (0.05 to 0.17)
    0.09 (0.05 to 0.1)
    0.1 (0.05 to 0.17)
    Notes
    [7] - Final PK analysis set.
    [8] - Final PK analysis set.
    [9] - Final PK analysis set.
    [10] - Final PK analysis set.
    No statistical analyses for this end point

    Primary: Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group

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    End point title
    		 Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group [11]
    End point description
    Apparent volume of distribution at steady state expressed in Liters after intravenous injection.
    End point type
    Primary
    End point timeframe
    From injection up to 8 hours after Gadobutrol injection
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed since as planned all continuous and ordinal categorical variables were analyzed by descriptive statistics only.
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    45 [12]
    39 [13]
    46 [14]
    130 [15]
    Units: liters
        median (inter-quartile range (Q1-Q3))
    3.83 (3.24 to 6.33)
    5.98 (4.06 to 11.69)
    10.02 (5.16 to 14.12)
    5.96 (3.27 to 13.21)
    Notes
    [12] - Final PK analysis set.
    [13] - Final PK analysis set.
    [14] - Final PK analysis set.
    [15] - Final PK analysis set.
    No statistical analyses for this end point

    Primary: Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group

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    End point title
    		 Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group [16]
    End point description
    Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection.
    End point type
    Primary
    End point timeframe
    From injection to 8 hours after Gadobutrol injection
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed since as planned all continuous and ordinal categorical variables were analyzed by descriptive statistics only.
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    45 [17]
    39 [18]
    46 [19]
    130 [20]
    Units: liter per kilogram
        median (inter-quartile range (Q1-Q3))
    0.24 (0.2 to 0.28)
    0.19 (0.14 to 0.23)
    0.18 (0.09 to 0.23)
    0.2 (0.12 to 0.28)
    Notes
    [17] - Final PK analysis set
    [18] - Final PK analysis set
    [19] - Final PK analysis set
    [20] - Final PK analysis set
    No statistical analyses for this end point

    Primary: Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group

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    End point title
    		 Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group [21]
    End point description
    Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in micromole*hour per liter (µmol*h/L).
    End point type
    Primary
    End point timeframe
    From injection to 8 hours after Gadobutrol injection
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed since as planned all continuous and ordinal categorical variables were analyzed by descriptive statistics only.
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    45 [22]
    39 [23]
    46 [24]
    130 [25]
    Units: µmol*h/L
        median (inter-quartile range (Q1-Q3))
    815 (494 to 1167)
    969 (590 to 2163)
    1167 (925 to 1808)
    999 (590 to 1808)
    Notes
    [22] - Final PK analysis set
    [23] - Final PK analysis set
    [24] - Final PK analysis set
    [25] - Final PK analysis set
    No statistical analyses for this end point

    Primary: Terminal Elimination Half Life Estimates of Gadobutrol by Age Group

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    End point title
    		 Terminal Elimination Half Life Estimates of Gadobutrol by Age Group [26]
    End point description
    Terminal elimination half-life of Gadobutrol from plasma expressed in hours and derived from the terminal slope of the concentration versus time curve.
    End point type
    Primary
    End point timeframe
    From injection to 8 hours after Gadobutrol injection
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed since as planned all continuous and ordinal categorical variables were analyzed by descriptive statistics only.
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    45 [27]
    39 [28]
    46 [29]
    130 [30]
    Units: hours
        median (inter-quartile range (Q1-Q3))
    1.75 (1.34 to 2.3)
    1.61 (1.17 to 2.62)
    1.65 (1.42 to 2.23)
    1.69 (1.34 to 2.32)
    Notes
    [27] - Final PK analysis set
    [28] - Final PK analysis set
    [29] - Final PK analysis set
    [30] - Final PK analysis set
    No statistical analyses for this end point

    Primary: Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group

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    End point title
    		 Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group [31]
    End point description
    Mean residence time of Gadobutrol in plasma expressed in hours.
    End point type
    Primary
    End point timeframe
    From injection to 8 hours after Gadobutrol injection
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed since as planned all continuous and ordinal categorical variables were analyzed by descriptive statistics only.
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    45 [32]
    39 [33]
    46 [34]
    130 [35]
    Units: hours
        median (inter-quartile range (Q1-Q3))
    1.88 (1.24 to 2.77)
    1.83 (1.03 to 3.37)
    2.03 (1.57 to 2.99)
    1.94 (1.24 to 2.99)
    Notes
    [32] - Final PK analysis set
    [33] - Final PK analysis set
    [34] - Final PK analysis set
    [35] - Final PK analysis set
    No statistical analyses for this end point

    Secondary: Urinary Excretion of Gadolinium as Percent of Administered Dose

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    End point title
    		 Urinary Excretion of Gadolinium as Percent of Administered Dose
    End point description
    Amount of gadolinium (a metallic rare-earth element, used as a contrast medium for magnetic resonance imaging) excreted into urine during the collection interval 0 - 6 hours post dose expressed as percentage of administered dose.
    End point type
    Secondary
    End point timeframe
    up to 6 hours after Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    22 [36]
    34 [37]
    41 [38]
    97 [39]
    Units: percentage of administered dose
        median (inter-quartile range (Q1-Q3))
    93.78 (9.19 to 187.73)
    92.14 (18.96 to 117.18)
    95.96 (3.48 to 139.03)
    94.13 (3.48 to 187.73)
    Notes
    [36] - Urinary analysis set
    [37] - Urinary analysis set
    [38] - Urinary analysis set
    [39] - Urinary analysis set
    No statistical analyses for this end point

    Secondary: Number of Subjects With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group

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    End point title
    		 Number of Subjects With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group
    End point description
    In the subjects the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate [compromised quality], 2=partially adequate [evaluation possible], 3=adequate despite artifacts, 4=adequate with excellent quality).
    End point type
    Secondary
    End point timeframe
    Up to 1 hour after Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [40]
    44 [41]
    48 [42]
    138 [43]
    Units: subjects
        not adequate (compromised quality)
    0
    0
    1
    1
        partially adequate (evaluation possible)
    0
    0
    0
    0
        adequate despite artifacts
    12
    13
    14
    39
        adequate with excellent quality
    34
    31
    33
    98
    Notes
    [40] - FAS
    [41] - FAS
    [42] - FAS
    [43] - FAS
    No statistical analyses for this end point

    Secondary: Number of Subjects With Overall Contrast Quality of Post Contrast Images by Age Group

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    End point title
    		 Number of Subjects With Overall Contrast Quality of Post Contrast Images by Age Group
    End point description
    In the subjects qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable).
    End point type
    Secondary
    End point timeframe
    up to 1 hour after Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [44]
    44 [45]
    48 [46]
    138 [47]
    Units: subjects
        none
    0
    0
    0
    0
        poor
    0
    0
    0
    0
        moderate
    0
    0
    3
    3
        good
    9
    17
    13
    39
        excellent
    37
    27
    32
    96
        not assessable
    0
    0
    0
    0
    Notes
    [44] - FAS
    [45] - FAS
    [46] - FAS
    [47] - FAS
    No statistical analyses for this end point

    Secondary: Pre-Contrast Lesions by Location and by Age Group

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    End point title
    		 Pre-Contrast Lesions by Location and by Age Group
    End point description
    Number of lesions on pre-contrast images by organ location and age group.
    End point type
    Secondary
    End point timeframe
    Immediately before Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [48]
    44 [49]
    48 [50]
    138 [51]
    Units: lesions
        Kidney
    5
    0
    8
    13
        Liver
    0
    0
    0
    0
        Brain
    34
    32
    30
    96
        Vessel
    0
    0
    0
    0
        Spine
    7
    2
    1
    10
    Notes
    [48] - FAS
    [49] - FAS
    [50] - FAS
    [51] - FAS
    No statistical analyses for this end point

    Secondary: Post-Contrast Lesions by Location and by Age Group

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    End point title
    		 Post-Contrast Lesions by Location and by Age Group
    End point description
    Number of lesions on post-contrast images by organ location and age group.
    End point type
    Secondary
    End point timeframe
    up to 1 hour after Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [52]
    44 [53]
    48 [54]
    138 [55]
    Units: lesions
        Kidney
    6
    0
    5
    11
        Liver
    0
    0
    0
    0
        Brain
    33
    32
    34
    99
        Vessel
    0
    0
    2
    2
        Spine
    7
    2
    1
    10
    Notes
    [52] - FAS
    [53] - FAS
    [54] - FAS
    [55] - FAS
    No statistical analyses for this end point

    Secondary: Pre-Contrast Delineation of Lesion/Vessel Border by Age Group

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    End point title
    		 Pre-Contrast Delineation of Lesion/Vessel Border by Age Group
    End point description
    In the subjects pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).
    End point type
    Secondary
    End point timeframe
    Immediately before Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [56]
    44 [57]
    48 [58]
    138 [59]
    Units: lesions
        no
    3
    0
    1
    4
        moderate
    5
    0
    5
    10
        good
    20
    20
    15
    55
        excellent
    18
    14
    18
    50
        not assessable
    0
    0
    0
    0
    Notes
    [56] - FAS
    [57] - FAS
    [58] - FAS
    [59] - FAS
    No statistical analyses for this end point

    Secondary: Post-Contrast Delineation of Lesion/Vessel Border by Age Group

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    End point title
    		 Post-Contrast Delineation of Lesion/Vessel Border by Age Group
    End point description
    In the subjects post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).
    End point type
    Secondary
    End point timeframe
    up to 1 hour after Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [60]
    44 [61]
    48 [62]
    138 [63]
    Units: lesions
        no
    0
    0
    5
    5
        moderate
    0
    4
    7
    11
        good
    14
    10
    10
    34
        excellent
    30
    20
    19
    69
        not assessable
    2
    0
    1
    2
    Notes
    [60] - FAS
    [61] - FAS
    [62] - FAS
    [63] - FAS
    No statistical analyses for this end point

    Secondary: Pre-Contrast Lesion Characterization by Age Group

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    End point title
    		 Pre-Contrast Lesion Characterization by Age Group
    End point description
    In the subjects the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).
    End point type
    Secondary
    End point timeframe
    Immediately before Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [64]
    44 [65]
    48 [66]
    138 [67]
    Units: lesions
        poor
    3
    1
    2
    6
        moderate
    6
    6
    6
    18
        good
    36
    27
    30
    93
        not applicable
    1
    0
    1
    2
    Notes
    [64] - FAS
    [65] - FAS
    [66] - FAS
    [67] - FAS
    No statistical analyses for this end point

    Secondary: Post-Contrast Lesion Characterization by Age Group

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    End point title
    		 Post-Contrast Lesion Characterization by Age Group
    End point description
    In the subjects the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).
    End point type
    Secondary
    End point timeframe
    up to 1 hour after Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [68]
    44 [69]
    48 [70]
    138 [71]
    Units: lesions
        poor
    1
    0
    6
    7
        moderate
    2
    3
    6
    11
        good
    42
    31
    25
    98
        not applicable
    1
    0
    5
    6
    Notes
    [68] - FAS
    [69] - FAS
    [70] - FAS
    [71] - FAS
    No statistical analyses for this end point

    Secondary: Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)

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    End point title
    		 Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)
    End point description
    In the subjects the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable).
    End point type
    Secondary
    End point timeframe
    up to 1 hour after Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [72]
    44 [73]
    48 [74]
    138 [75]
    Units: lesions
        no
    19
    19
    18
    56
        moderate
    1
    1
    4
    6
        good
    3
    4
    2
    9
        excellent
    20
    10
    16
    46
        not applicable
    3
    0
    2
    5
    Notes
    [72] - FAS
    [73] - FAS
    [74] - FAS
    [75] - FAS
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change in Diagnostic Confidence by Age Group

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    End point title
    		 Number of Subjects With Change in Diagnostic Confidence by Age Group
    End point description
    In the subjects the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened).
    End point type
    Secondary
    End point timeframe
    up to 1 hour after Gadobutrol injection
    End point values
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Number of subjects analysed
    46 [76]
    44 [77]
    48 [78]
    138 [79]
    Units: subjects
        missing
    0
    0
    1
    1
        unchanged
    3
    3
    5
    11
        improved
    43
    41
    42
    126
        worsened
    0
    0
    0
    0
    Notes
    [76] - FAS
    [77] - FAS
    [78] - FAS
    [79] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Immediately after injection up to 7 days post injection
    Adverse event reporting additional description
    As assessed by the investigators, 10 of the 74 adverse events recorded were related to administration of Gadobutrol and 3 of these, that is, crystal urine, pneumonia and meningitis (1.4%) were assessed as serious.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Gadobutrol - Age 2 to 6 Years
    Reporting group description
    		 Subjects in the age range of 2 to 6 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Reporting group title
    Gadobutrol - Age 7 to 11 Years
    Reporting group description
    		 Subjects in the age range of 7 to 11 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Reporting group title
    Gadobutrol - Age 12 to 17 Years
    Reporting group description
    		 Subjects in the age range of 12 to 17 years, received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection.

    Reporting group title
    Gadobutrol - Age 2 to 17 Years
    Reporting group description
    		 Subjects received Gadobutrol 0.1 mmol/kg BW = 0.1 mL/kg BW as single intravenous bolus injection. This reporting group consists of the overall study population aged 2 to 17 years which is the sum of all the above 3 reporting groups ("Gadobutrol - Age 2 to 6 Years"+"Gadobutrol - Age 7 to 11 Years"+"Gadobutrol - Age 12 to 17 Years").

    Serious adverse events
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    2 / 138 (1.45%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Crystal urine
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Meningitis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Gadobutrol - Age 2 to 6 Years Gadobutrol - Age 7 to 11 Years Gadobutrol - Age 12 to 17 Years Gadobutrol - Age 2 to 17 Years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 46 (36.96%)
    16 / 44 (36.36%)
    16 / 48 (33.33%)
    49 / 138 (35.51%)
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    1
    Feeling hot
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    2 / 48 (4.17%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    2
    2
    Pyrexia
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 44 (4.55%)
    1 / 48 (2.08%)
    5 / 138 (3.62%)
         occurrences all number
    2
    2
    1
    5
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    Investigations
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1
    Head injury
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    Dysgeusia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    2 / 48 (4.17%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    2
    2
    Headache
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 44 (4.55%)
    2 / 48 (4.17%)
    4 / 138 (2.90%)
         occurrences all number
    0
    3
    2
    5
    Blood and lymphatic system disorders
    Eosinophilia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 44 (2.27%)
    1 / 48 (2.08%)
    3 / 138 (2.17%)
         occurrences all number
    1
    1
    1
    3
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    2 / 48 (4.17%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    2
    2
    Constipation
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    1
    Enteritis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    1
    Nausea
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 44 (2.27%)
    3 / 48 (6.25%)
    5 / 138 (3.62%)
         occurrences all number
    1
    1
    3
    5
    Stomach discomfort
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    2 / 48 (4.17%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    2
    2
    Vomiting
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 44 (4.55%)
    1 / 48 (2.08%)
    5 / 138 (3.62%)
         occurrences all number
    2
    2
    1
    5
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    Rash
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    2 / 138 (1.45%)
         occurrences all number
    1
    0
    1
    2
    Rash pruritic
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    1
    Pruritus generalised
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    Leukocyturia
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 44 (4.55%)
    1 / 48 (2.08%)
    3 / 138 (2.17%)
         occurrences all number
    0
    2
    1
    3
    Pain in extremity
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 44 (0.00%)
    1 / 48 (2.08%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 46 (4.35%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    2
    1
    0
    3
    Gastrointestinal infection
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    1 / 48 (2.08%)
    2 / 138 (1.45%)
         occurrences all number
    0
    1
    1
    2
    Otitis media
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 44 (2.27%)
    1 / 48 (2.08%)
    2 / 138 (1.45%)
         occurrences all number
    0
    1
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 44 (2.27%)
    0 / 48 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    1
    0
    2
    Central line infection
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jun 2007
    Rationale for the amendment was that in compliance with additional recommendations made on 27 March 2007 by The German Federal Institute for Drugs and Medical Devices (BfArM), the sections referring to the urine collection in children needed to be amended. The BfArM recommended that the urine collection should not only be performed in children aged at least 9 years but also in capable younger children. Provided that the children/parents were cooperating and that no additional strain was put on the children, it had to be endeavored to also gain data about the gadobutrol urine excretion in younger children - even in the youngest age group (2-6 years), if feasible.

    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.
    Originally, urine was collected up to 6 hours post injection in subjects >9 years. This was amended to subjects of all age groups. As a result, urine was collected in 102 of 138 subjects with gadobutrol injection (lowest rate in subjects 2-6 years).

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/19858730
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