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    Clinical Trial Results:
    A PHASE III, MULTI-CENTER, OPEN-LABEL STUDY TO EVALUATE SAFETY AND EFFICACY OF MULTIHANCE® AT THE DOSE OF 0.10 mmol/kg IN MAGNETIC RESONANCE IMAGING OF THE CENTRAL NERVOUS SYSTEM IN PEDIATRIC PATIENTS.

    Summary
    EudraCT number
    		 2005-004170-25
    Trial protocol
    		 DE   BE   IT  
    Global end of trial date
    26 Sep 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2016
    First version publication date
    31 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MH-110
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00323310
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bracco Diagnostics, Inc.
    Sponsor organisation address
    259 Prospect Plains Rd, Cranbury, United States, 08512
    Public contact
    Gianpaolo Pirovano, Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc, (609) 514-2200,
    Scientific contact
    Gianpaolo Pirovano, Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc, (609) 514-2200,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of MULTIHANCE at a dose of 0.1 mmol/kg in MRI of the CNS in pediatric patients, in terms of by lesion changes from predose to pre + postdose with regard to the following co-primary visualization endpoints: - Border delineation of lesions - internal morphology of lesions - Contrast enhancement of lesions To assess the safety of MULTIHANCE at a dose of 0.1 mmol/kg in terms of adverse events and changes in vital signs, ECG findings and laboratory findings.
    Protection of trial subjects
    If sedation and/or anesthesia are planned to be administered, the Investigator must carefully perform and monitor patients according to the approved local institution policies. Also obtain an additional predose vital signs series and ECG after sedation/anesthesia is started and immediately before the predose MRI.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Apr 2006
    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
    China: 9
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    United States: 36
    Worldwide total number of subjects
    94
    EEA total number of subjects
    48
    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)
    55
    Adolescents (12-17 years)
    39
    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
    		 Study Initiation Date (first subject enrolled): April 4, 2006; Study completion date (last patient completed study related activities): Sept 26, 2006. The study was conducted at 17 investigational sites. Based on new sample size calculation and adequate distribution of disease/ages of patients, the study was terminated after 94 patients enrolled.

    Pre-assignment
    Screening details
    		 Male or female between 2 and 17 years old, inclusive; written informed consent obtained from the patient’s parents or legal acceptable representative(s); assent from the patient when applicable; known or highly suspected disease of the CNS (brain/spine) and referred for cranial or spinal MR examination requiring an injection of MR contrast agent.

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

    Arms
    Arm title
    		 Gadobenate Dimeglumine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadobenate Dimeglumine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    A dose of 0.1 mmol/kg (i.e., 0.2 mL/kg) of 0.5 M MULTIHANCE was administered intravenously at a rate not exceeding 2 mL/sec followed by a saline flush that ensured adequate delivery of the investigational product to the patient.

    Number of subjects in period 1
    		Gadobenate Dimeglumine
    Started
    94
    Completed
    92
    Not completed
    2
         Equipment malfunction
    1
         Had emesis x1 prior to sedation/MRI cancelled
    1
    Period 2
    Period 2 title
    Postdose
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Gadobenate Dimeglumine
    Arm description
    		 Gadobenate Dimeglumine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gadobenate Dimeglumine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    A dose of 0.1 mmol/kg (i.e., 0.2 mL/kg) of 0.5 M MULTIHANCE was administered intravenously at a rate not exceeding 2 mL/sec followed by a saline flush that ensured adequate delivery of the investigational product to the patient.

    Number of subjects in period 2
    		Gadobenate Dimeglumine
    Started
    92
    Completed
    89
    Not completed
    3
         Consent withdrawn by subject
    1
         Did not complete the 24-hr follow up visit
    1
         A parent refused blood draw
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gadobenate Dimeglumine
    Reporting group description
    		 -

    Reporting group values
    		 Gadobenate Dimeglumine Total
    Number of subjects
    		 94 94
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 55 55
        Adolescents (12-17 years)
    		 39 39
    Gender categorical
    Units: Subjects
        Female
    		 48 48
        Male
    		 46 46
    Subject analysis sets

    Subject analysis set title
    Subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants

    Subject analysis set title
    Dummy set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Due to the system limitation with the EudraCT system, a Dummy set was created and used to as a comparison group. EudraCT does not allow single arm/group statistical analysis. This is dummy set is a workaround to that limitation. No subjects in this set.

    Subject analysis sets values
    		 Subjects Dummy set
    Number of subjects
    92
    1
    Age categorical
    Units: Subjects
        Children (2-11 years)
    54
    0
        Adolescents (12-17 years)
    38
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    47
    0
        Male
    45
    0

    End points

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    End points reporting groups
    Reporting group title
    Gadobenate Dimeglumine
    Reporting group description
    		 -
    Reporting group title
    Gadobenate Dimeglumine
    Reporting group description
    		 Gadobenate Dimeglumine

    Subject analysis set title
    Subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants

    Subject analysis set title
    Dummy set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Due to the system limitation with the EudraCT system, a Dummy set was created and used to as a comparison group. EudraCT does not allow single arm/group statistical analysis. This is dummy set is a workaround to that limitation. No subjects in this set.

    Primary: Delineation of Lesion Border(Change From Pre to Pre+Postdose) for Reader 1

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    End point title
    		 Delineation of Lesion Border(Change From Pre to Pre+Postdose) for Reader 1
    End point description
    End point type
    Primary
    End point timeframe
    pre-dose and immediately postdose
    End point values
    		 Subjects Dummy set
    Number of subjects analysed
    92
    1
    Units: Lesions
    number (not applicable)
        Lesions Analyzed
    148
    0
        Predose
    1.7
    0
        Predose (STD)
    1.16
    0
        Pre+Postdose
    3
    0
        Pre+Postdose (STD)
    1.2
    0
    Statistical analysis title
    		 Change From Pre to Pre+Postdose for Reader 1
    Statistical analysis description
    Paired t-test to compare change from pre to pre+postdose
    Comparison groups
    Subjects v Dummy set
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001 [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.5
    Variability estimate
    Standard deviation
    Dispersion value
    1.46
    Notes
    [1] - Subjects in this analysis are 92
    [2] - H0: udiff = 0; Ha: udiff not = 0

    Primary: Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2

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    End point title
    		 Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
    End point description
    5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
    End point type
    Primary
    End point timeframe
    pre-dose and immediately postdose
    End point values
    		 Subjects Dummy set
    Number of subjects analysed
    92
    1
    Units: Lesions
    number (not applicable)
        Lesions Analyzed
    135
    0
        Predose
    1.9
    0
        Predose (STD)
    1.15
    0
        Pre+Postdoes
    3.1
    0
        Pre+Postdose (STD)
    1.11
    0
    Statistical analysis title
    		 Change From Pre to Pre+Postdose for Reader 2
    Statistical analysis description
    Paired t-test to compare change from pre to pre+postdose
    Comparison groups
    Subjects v Dummy set
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001 [4]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.4
    Variability estimate
    Standard deviation
    Dispersion value
    1.45
    Notes
    [3] - Subjects in this analysis are 92.
    [4] - H0: udiff = 0; Ha: udiff not = 0

    Primary: Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3

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    End point title
    		 Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
    End point description
    5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
    End point type
    Primary
    End point timeframe
    pre-dose and immediately postdose
    End point values
    		 Subjects Dummy set
    Number of subjects analysed
    92
    1
    Units: Lesions
    number (not applicable)
        Lesions Analyzed
    131
    0
        Predose
    1.7
    0
        Predose (STD)
    1.19
    0
        Pre+Postdose
    2.4
    0
        Pre+Postdose (STD)
    1.12
    0
    Statistical analysis title
    		 Change From Pre to Pre+Postdose for Reader 3
    Statistical analysis description
    Paired t-test to compare change from pre to pre+postdose
    Comparison groups
    Subjects v Dummy set
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.0001 [6]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.9
    Variability estimate
    Standard deviation
    Dispersion value
    1.42
    Notes
    [5] - Subjects in this analysis are 92
    [6] - H0: udiff = 0; Ha: udiff not = 0

    Primary: Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1

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    End point title
    		 Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
    End point description
    5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
    End point type
    Primary
    End point timeframe
    pre-dose to immediately post dose
    End point values
    		 Subjects Dummy set
    Number of subjects analysed
    92
    1
    Units: Lesions
    number (not applicable)
        Lesions Analyzed
    148
    0
        Predose
    1.9
    0
        Predose (STD)
    1.18
    0
        Pre+Postdose
    3.2
    0
        Pre+Postdose (STD)
    1.19
    0
    Statistical analysis title
    		 Change From Pre to Pre+Postdose for Reader 1
    Statistical analysis description
    Paired t-test to compare change from pre to pre+postdose
    Comparison groups
    Subjects v Dummy set
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.001 [8]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.6
    Variability estimate
    Standard deviation
    Dispersion value
    1.56
    Notes
    [7] - Subjects in this analysis are 92
    [8] - H0: udiff = 0; Ha: udiff not = 0

    Primary: Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2

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    End point title
    		 Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
    End point description
    5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
    End point type
    Primary
    End point timeframe
    pre-dose to immediately post dose
    End point values
    		 Subjects Dummy set
    Number of subjects analysed
    92
    1
    Units: Lesions
    number (not applicable)
        Lesions Analyzed
    135
    0
        Predose
    2.1
    0
        Predose (STD)
    1.17
    0
        Pre+Postdose
    3.2
    0
        Pre+Postdose (STD)
    1.13
    0
    Statistical analysis title
    		 Change From Pre to Pre+Postdose for Reader 2
    Statistical analysis description
    Paired t-test to compare change from pre to pre+postdose
    Comparison groups
    Dummy set v Subjects
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 < 0.001 [10]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.4
    Variability estimate
    Standard deviation
    Dispersion value
    1.49
    Notes
    [9] - Subjects in this analysis are 92
    [10] - H0: udiff = 0; Ha: udiff not = 0

    Primary: Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3

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    End point title
    		 Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
    End point description
    5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
    End point type
    Primary
    End point timeframe
    pre-dose to immediately postdose
    End point values
    		 Subjects Dummy set
    Number of subjects analysed
    92
    1
    Units: Lesions
    number (not applicable)
        Lesions Analyzed
    131
    0
        Predose
    1.4
    0
        Predose (STD)
    1.06
    0
        Pre+Postdose
    2
    0
        Pre+Postdose (STD)
    1.23
    0
    Statistical analysis title
    		 Change From Pre to Pre+Postdose for Reader 3
    Statistical analysis description
    Paired t-test to compare change from pre to pre+postdose
    Comparison groups
    Subjects v Dummy set
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 < 0.0001 [12]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.8
    Variability estimate
    Standard deviation
    Dispersion value
    1.2
    Notes
    [11] - Subjects in this analysis are 92.
    [12] - H0: udiff = 0; Ha: udiff not = 0

    Primary: Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1

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    End point title
    		 Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
    End point description
    5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
    End point type
    Primary
    End point timeframe
    pre-dose and immediately postdose
    End point values
    		 Subjects Dummy set
    Number of subjects analysed
    92
    1
    Units: Lesions
    number (not applicable)
        Lesions Analyzed
    148
    0
        Predose
    1.8
    0
        Predose (STD)
    1.16
    0
        Pre+Postdose
    3
    0
        Pre+Postdose (STD)
    1.19
    0
    Statistical analysis title
    		 Change From Pre to Pre+Postdose for Reader 1
    Statistical analysis description
    Paired t-test to compare change from pre to pre+postdose
    Comparison groups
    Subjects v Dummy set
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 < 0.0001 [14]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.5
    Variability estimate
    Standard deviation
    Dispersion value
    1.57
    Notes
    [13] - Subjects in this analysis are 92
    [14] - H0: udiff = 0; Ha: udiff not = 0

    Primary: Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2

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    End point title
    		 Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
    End point description
    5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
    End point type
    Primary
    End point timeframe
    pre-dose to immediately postdose
    End point values
    		 Subjects Dummy set
    Number of subjects analysed
    92
    1
    Units: Lesions
    number (not applicable)
        Lesions Analyzed
    135
    0
        Predose
    2
    0
        Predose (STD)
    1.2
    0
        Pre+Postdose
    3.2
    0
        Pre+Postdose (STD)
    1.12
    0
    Statistical analysis title
    		 Change From Pre to Pre+Postdose for Reader 2
    Statistical analysis description
    Paired t-test to compare change from pre to pre+postdose
    Comparison groups
    Subjects v Dummy set
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 < 0.0001 [16]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.4
    Variability estimate
    Standard deviation
    Dispersion value
    1.49
    Notes
    [15] - Subjects in this analysis are 92
    [16] - H0: udiff = 0; Ha: udiff not = 0

    Primary: Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3

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    End point title
    		 Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
    End point description
    5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
    End point type
    Primary
    End point timeframe
    pre-dose to immediately postdose
    End point values
    		 Subjects Dummy set
    Number of subjects analysed
    92
    1
    Units: Lesions
    number (not applicable)
        Lesions Analyzed
    131
    0
        Predose
    1.4
    0
        Predose (STD)
    0.96
    0
        Pre+Postdose
    2.2
    0
        Pre+Postdose (STD)
    1.41
    0
    Statistical analysis title
    		 Change From Pre to Pre+Postdose for Reader 3
    Statistical analysis description
    Paired t-test to compare change from pre to pre+postdose
    Comparison groups
    Subjects v Dummy set
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.1
    Variability estimate
    Standard deviation
    Dispersion value
    1.54
    Notes
    [17] - Subjects in this analysis are 92.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 72 hours post dose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 92 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 92 (8.70%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 92 (2.17%)
         occurrences all number
    2
    Somnolence
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences all number
    1
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences all number
    1
    Infections and infestations
    Otitis media
         subjects affected / exposed
    1 / 92 (1.09%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2007
    Changes in the Conduct of the Study The final date of the protocol was December 22, 2005. There was 1 amendment to the final protocol (Amendment 1 [January 15, 2007]): • As a proactive safety precaution, in response to recent reports of nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD), a rapidly-progressive fibrosis of unknown pathophysiology, occurring in some patients with severe renal impairment who received a gadolinium contrast agent, the exclusion of patients having moderate-to-severe renal impairment (GFR/eGFR < 60 mL/min) was added to provide a greater margin of safety.

    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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