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    Clinical Trial Results:
    Prospective non-randomized (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Primovist/Eovist in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF) based on diagnostically specific clinical and histopathologic information.

    Summary
    EudraCT number
    2008-005867-33
    Trial protocol
    DE   AT   GB  
    Global end of trial date
    24 Jul 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    02 Sep 2016
    First version publication date
    17 Jul 2015
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    Bayer sponsor contact information to be updated

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY86-4873/13701
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00908596
    WHO universal trial number (UTN)
    -
    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)
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the magnitude of the potential risk of developing NSF with the administration of Primovist/Eovist in patients with moderate to severe renal impairment, based on diagnostically specific clinical and histopathological information.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. 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 guideline E6: Good Clinical Practice. Only after the subject voluntarily signed the informed consent form was he/she able to enter the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 May 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 13
    Country: Number of subjects enrolled
    Germany: 57
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Italy: 43
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    Korea, Republic of: 107
    Country: Number of subjects enrolled
    United States: 47
    Country: Number of subjects enrolled
    Thailand: 50
    Country: Number of subjects enrolled
    United Kingdom: 4
    Worldwide total number of subjects
    364
    EEA total number of subjects
    153
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    168
    From 65 to 84 years
    188
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    The first subject's first visit was on 21 May 2009. Subjects were screened and enrolled in 35 study centers across Australia, Austria, Germany, Italy, Spain, South Korea, United Kingdom, United states, and Thailand, and undergone contrast enhanced (CE) magnetic resonance imaging (MRI) of liver with Primovist/Eovist within the approved indications.

    Pre-assignment
    Screening details
    A total of 364 subjects were enrolled. Of these, 4 were withdrawn prior to MRI already since they failed to meet the study entrance criteria, and 3 were withdrawn for other reasons. Subjects had to have moderate to severe renal impairment [estimated glomerular filtration rate (eGFR) 65 milliliter (mL)/minute (min)/1.73 square meter (m^2) or less].

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Gadoxetic Acid Disodium - Mild Renal Impairment
    Arm description
    Subjects with eGFR prior to Primovist/Eovist injection greater than (>) 65 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.
    Arm type
    Experimental

    Investigational medicinal product name
    Primovist/Eovist
    Investigational medicinal product code
    BAY86-4873
    Other name
    Gadoxetate disodium
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Subjects received Primovist/Eovist intravenously at a dose of 0.025 millimoles per kilogram (mmol/kg) body weight (BW).

    Arm title
    Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
    Arm description
    Subjects with eGFR prior to Primovist/Eovist injection between > 59 and less than or equal to (≤) 65 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.
    Arm type
    Experimental

    Investigational medicinal product name
    Primovist/Eovist
    Investigational medicinal product code
    BAY86-4873
    Other name
    Gadoxetate disodium
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Subjects received Primovist/Eovist intravenously at a dose of 0.025 mmol/kg BW.

    Arm title
    Gadoxetic Acid Disodium - Moderate Renal Impairment
    Arm description
    Subjects with eGFR prior to Primovist/Eovist injection between greater than or equal to (≥) 30 and ≤ 59 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.
    Arm type
    Experimental

    Investigational medicinal product name
    Primovist/Eovist
    Investigational medicinal product code
    BAY86-4873
    Other name
    Gadoxetate disodium
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Subjects received Primovist/Eovist intravenously at a dose of 0.025 mmol/kg BW.

    Arm title
    Gadoxetic Acid Disodium - Severe Renal Impairment
    Arm description
    Subjects on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.
    Arm type
    Experimental

    Investigational medicinal product name
    Primovist/Eovist
    Investigational medicinal product code
    BAY86-4873
    Other name
    gadoxetate disodium
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Subjects received Primovist/Eovist intravenously at a dose of 0.025 mmol/kg BW.

    Number of subjects in period 1 [1]
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
    Started
    47
    32
    193
    85
    Completed
    0
    19
    119
    48
    Not completed
    47
    13
    74
    37
         Death
    -
    5
    57
    32
         Protocol violation
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    1
    3
    1
         Other reasons
    46
    6
    2
    -
         Lost to follow-up
    -
    1
    12
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Not all the enrolled subjects were treated with study drugs. As baseline included only treated subjects, the worldwide number enrolled in the trial differs with the number of subjects reported in the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gadoxetic Acid Disodium - Mild Renal Impairment
    Reporting group description
    Subjects with eGFR prior to Primovist/Eovist injection greater than (>) 65 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group title
    Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
    Reporting group description
    Subjects with eGFR prior to Primovist/Eovist injection between > 59 and less than or equal to (≤) 65 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group title
    Gadoxetic Acid Disodium - Moderate Renal Impairment
    Reporting group description
    Subjects with eGFR prior to Primovist/Eovist injection between greater than or equal to (≥) 30 and ≤ 59 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group title
    Gadoxetic Acid Disodium - Severe Renal Impairment
    Reporting group description
    Subjects on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group values
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment Total
    Number of subjects
    47 32 193 85 357
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65.3 ± 9.55 65.3 ± 12.03 65.5 ± 10.88 62.2 ± 13.83 -
    Gender categorical
    Units: Subjects
        Female
    20 7 46 30 103
        Male
    27 25 147 55 254
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    15 9 101 63 188
        Black
    2 1 6 2 11
        Hispanic
    0 1 3 0 4
        Asian
    27 16 56 8 107
        Other
    3 5 27 12 47

    End points

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    End points reporting groups
    Reporting group title
    Gadoxetic Acid Disodium - Mild Renal Impairment
    Reporting group description
    Subjects with eGFR prior to Primovist/Eovist injection greater than (>) 65 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group title
    Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
    Reporting group description
    Subjects with eGFR prior to Primovist/Eovist injection between > 59 and less than or equal to (≤) 65 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group title
    Gadoxetic Acid Disodium - Moderate Renal Impairment
    Reporting group description
    Subjects with eGFR prior to Primovist/Eovist injection between greater than or equal to (≥) 30 and ≤ 59 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group title
    Gadoxetic Acid Disodium - Severe Renal Impairment
    Reporting group description
    Subjects on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    FAS (N=357) included all subjects who were enrolled and received Primovist/Eovist.

    Primary: Number of Subjects With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information

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    End point title
    Number of Subjects With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information [1]
    End point description
    A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.
    End point type
    Primary
    End point timeframe
    Up to 24 months following the administration of Primovist/Eovist
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
    Number of subjects analysed
    47 [2]
    32 [3]
    193 [4]
    85 [5]
    Units: subjects
    0
    0
    0
    0
    Notes
    [2] - FAS
    [3] - FAS
    [4] - FAS
    [5] - FAS
    No statistical analyses for this end point

    Secondary: Number of Subjects With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score

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    End point title
    Number of Subjects With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score
    End point description
    Subjects in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.
    End point type
    Secondary
    End point timeframe
    Up to 24 months following the administration of Primovist/Eovist
    End point values
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
    Number of subjects analysed
    47 [6]
    32 [7]
    193 [8]
    85 [9]
    Units: subjects
    0
    0
    0
    0
    Notes
    [6] - FAS
    [7] - FAS
    [8] - FAS
    [9] - FAS
    No statistical analyses for this end point

    Secondary: Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)

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    End point title
    Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
    End point description
    The investigator was to record his/her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some subjects, the values were not collected.
    End point type
    Secondary
    End point timeframe
    Immediately after Primovist/Eovist-enhanced MRI
    End point values
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
    Number of subjects analysed
    47 [10]
    32 [11]
    193 [12]
    85 [13]
    Units: subjects
        Very high
    26
    16
    98
    33
        High
    15
    13
    80
    38
        Moderate
    5
    3
    12
    4
        Low
    1
    0
    2
    1
    Notes
    [10] - FAS
    [11] - FAS
    [12] - FAS
    [13] - FAS
    No statistical analyses for this end point

    Secondary: Number of Subjects With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Detection

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    End point title
    Number of Subjects With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Detection
    End point description
    The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some subjects, the values were not collected.
    End point type
    Secondary
    End point timeframe
    Immediately after Primovist/Eovist-enhanced MRI
    End point values
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
    Number of subjects analysed
    47 [14]
    32 [15]
    193 [16]
    85 [17]
    Units: subjects
        Excellent
    29
    20
    99
    34
        Good
    15
    12
    74
    29
        Adequate
    1
    0
    15
    8
        Insufficient
    0
    0
    1
    2
    Notes
    [14] - FAS
    [15] - FAS
    [16] - FAS
    [17] - FAS
    No statistical analyses for this end point

    Secondary: Number of Subjects With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Delineation

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    End point title
    Number of Subjects With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Delineation
    End point description
    The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some subjects, the values were not collected.
    End point type
    Secondary
    End point timeframe
    Immediately after Primovist/Eovist-enhanced MRI
    End point values
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
    Number of subjects analysed
    47 [18]
    32 [19]
    193 [20]
    85 [21]
    Units: subjects
        Excellent
    27
    16
    94
    31
        Good
    15
    16
    77
    34
        Adequate
    3
    0
    16
    6
        Insufficient
    0
    0
    1
    3
    Notes
    [18] - FAS
    [19] - FAS
    [20] - FAS
    [21] - FAS
    No statistical analyses for this end point

    Secondary: Number of Subjects With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Characterization

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    End point title
    Number of Subjects With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Characterization
    End point description
    The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some subjects, the values were not collected.
    End point type
    Secondary
    End point timeframe
    Immediately after Primovist/Eovist-enhanced MRI
    End point values
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment
    Number of subjects analysed
    47 [22]
    32 [23]
    193 [24]
    85 [25]
    Units: subjects
        Excellent
    30
    13
    93
    33
        Good
    12
    16
    79
    34
        Adequate
    2
    3
    14
    5
        Insufficient
    1
    0
    2
    2
    Notes
    [22] - FAS
    [23] - FAS
    [24] - FAS
    [25] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 months following the administration of Primovist/Eovist
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Gadoxetic Acid Disodium - Mild Renal Impairment
    Reporting group description
    Subjects with eGFR prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group title
    Gadoxetic Acid Disodium - Moderate Renal Impairment
    Reporting group description
    Subjects with eGFR prior to Primovist/Eovist injection between >=30 and <=59 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group title
    Gadoxetic Acid Disodium - Severe Renal Impairment
    Reporting group description
    Subjects on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection <30 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Reporting group title
    Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
    Reporting group description
    Subjects with eGFR prior to Primovist/Eovist injection between >59 and <=65 mL/min/1.73 m^2. Subjects received Primovist/Eovist as part of their routine medical care.

    Serious adverse events
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    57
    32
    5
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         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
    Gadoxetic Acid Disodium - Mild Renal Impairment Gadoxetic Acid Disodium - Moderate Renal Impairment Gadoxetic Acid Disodium - Severe Renal Impairment Gadoxetic Acid Disodium - Extended Moderate Renal Impairment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 47 (0.00%)
    7 / 193 (3.63%)
    6 / 85 (7.06%)
    1 / 32 (3.13%)
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    0 / 85 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermal cyst
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 47 (0.00%)
    4 / 193 (2.07%)
    2 / 85 (2.35%)
    0 / 32 (0.00%)
         occurrences all number
    0
    4
    2
    0
    Rash papular
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus generalised
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    0 / 85 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Extremity contracture
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 193 (0.00%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 193 (1.04%)
    0 / 85 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Rash pustular
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 193 (0.52%)
    1 / 85 (1.18%)
    0 / 32 (0.00%)
         occurrences all number
    0
    1
    1
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jul 2010
    Global protocol amendment 4 contained a change in list of participating countries, change of exclusion criteria (to allow for inclusion of subjects who had prior exposure to Primovist/Eovist), additional definition of per protocol set for analysis, update of procedures for subject identification numbers, extension of subject population to be included in the safety follow-up, correction of mistake with regard to cytokine evaluation and clarification of time point for blood sample at baseline, correction of mistake in wording of explanatory text for inclusion criterion, and correction of mistake regarding baseline blood sample. At the express request of the Korean authority, the integrated protocol for global protocol amendment 4 , also contained the changes introduced by local amendments 1 (Austria) and 2 (Korea). Unless otherwise specified, it did not contain the changes introduced by local amendment 3 (United Kingdom).
    10 Aug 2011
    Global protocol amendment 5 contained an update to reflect changes in study personnel, removal of the planned study schedule from synopsis, addition of risk categories defined by the European Medicines Agency, clarification of responsibility for the physical examination, addition of a definition for pre-treatment adverse events (AEs), update of expected AEs, clarification of process for reporting serious adverse events clarification regarding direct data entry in case report forms (CRFs), update of archiving requirements, and the correction of mistake with regard to labeling of CRF pages.

    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.
    The study was stopped early since Food and Drug Administration (FDA) released the sponsor from completing enrollment because the NSF incidence estimate was lower than the original literature–based estimate, and enrollment quota was not feasible.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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