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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013081-17 | EudraCT Number | ||
| 312046 | Other Identifier | company internal |
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The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age
Safety issues are addressed in the AE section
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-6661) | Experimental | For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-6661) | Drug | For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) | A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image. | Within 5 minutes after injection |
| Dose Determined by Blinded Readers to be Superior for Diagnosis | Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters | Within 5 minutes after injection |
| Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose. | Within 5 minutes after injection |
| PK Analysis - Total Clearance (CL) | Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug. | 20 to 45 min and 4 to 8 hours post injection |
| PK Analysis - Total Clearance (CL)/Body Weight (BW) | CL/BW = total clearance normalized by BW | 20 to 45 min and 4 to 8 hours post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Number of Lesions Detected - Stage 1 | BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions. | Within 5 minutes after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | 92123 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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A subject was enrolled in EITHER Stage 1 or Stage 2 and not both. Overall for both stages, 61 participants were Screened, 7 were Screen Failures, and 54 participants were enrolled and treated of which 53 participants completed the study (20 unique participants in Stage 1 and 33 unique participants in Stage 2)
The date of the first participant, first visit was 21 Jan 2010. The date of the last participant, last visit was 09 Sep 2010. The date of the Blinded Read for Stage 1 was 27 Apr 2010. the date of the Blinded Read for Stage 2 was 08 Sep 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadopentetate Dimeglumine (Magnevist, BAY86-6661) | For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Another group of participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 |
| ||||||||||||||||
| Stage 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 1 | Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) | A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image. | The first 3 participants of Stage 1 received 2 IV injections of 0.05 mmol/kg body weight (BW), images were obtained after each injection and an assessment made by the CIs as to diagnostic adequacy. | Posted | Number | Participants | Within 5 minutes after injection |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gadopentetate Dimeglumine - Stage 1 | Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Krabbe's disease | Congenital, familial and genetic disorders | MedDRA{13.0} | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA{13.0} | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
Not provided
| ID | Term |
|---|---|
| D019786 | Gadolinium DTPA |
| ID | Term |
|---|---|
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
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|
| PK Analysis - Volume of Distribution at Steady State (Vss) | Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state. | 20 to 45 min and 4 to 8 hours post injection |
| PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW) | Vss/BW = volume of distribution at steady state normalized by body weight | 20 to 45 min and 4 to 8 hours post injection |
| PK Analysis - Area Under the Drug Concentration-time Curve (AUC) | AUC = Area under the drug concentration-time curve from administration to infinity | Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity. |
| PK Analysis - t 1/2 | t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity | Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity |
| Number of Participants With Number of Lesions Detected - Stage 2 | BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions. | Within 5 minutes after injection |
| Number of Participants With Quality of Lesion Visualization - Stage 1 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible) | Within 5 minutes after injection |
| Number of Participants With Quality of Lesion Visualization - Stage 2 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible) | Within 5 minutes after injection |
| Number of Participants With Quality of Border Delineation - Stage 1 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set | Within 5 minutes after injection |
| Number of Participants With Quality of Border Delineation - Stage 2 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set | Within 5 minutes after injection |
| Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images | Within 5 minutes after injection |
| Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images | Within 5 minutes after injection |
| Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator | Within 5 minutes after injection |
| Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2 | The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator | Within 5 minutes after injection |
| Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator. | Within 5 minutes after injection |
| Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2 | Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator | Within 5 minutes after injection |
| Number of Participants With Diagnostic Confidence - Stage 1 | The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator | Within 5 minutes after injection |
| Number of Participants With Diagnostic Confidence - Stage 2 | The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator | Within 5 minutes after injection |
| Management Based on Unenhanced Images - Stage 1 | For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators. | Within 5 minutes before injection |
| Management Based on Unenhanced Images - Stage 2 | For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators. | Within 5 minutes before injection |
| Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1 | For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses. | Within 5 minutes after injection |
| Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2 | For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1. | Within 5 minutes after injection |
| Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1 | Within 5 minutes after injection |
| Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 | The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1 | Within 5 minutes after injection |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Chicago | Illinois | 60614 | United States |
| Iowa City | Iowa | 52242 | United States |
| Kansas City | Missouri | 64108-9898 | United States |
| St Louis | Missouri | 63110 | United States |
| Akron | Ohio | 44308 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Houston | Texas | 77030 | United States |
| Dresden | Saxony | 01307 | Germany |
| Halle | Saxony-Anhalt | 06120 | Germany |
| Kiel | Schleswig-Holstein | 24105 | Germany |
| Jena | Thuringia | 07740 | Germany |
| NOT COMPLETED |
|
|
| Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 2 |
Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Body Weight | Mean | Standard Deviation | kg |
|
Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). |
|
|
| Primary | Dose Determined by Blinded Readers to be Superior for Diagnosis | Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters | Primary analysis set (the first 5 PPS participants in each age group) | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Primary | Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers | For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose. | Primary Analysis Set (the first 5 PPS participants in each age group) | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Primary | PK Analysis - Total Clearance (CL) | Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug. | PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples | Posted | Median | Full Range | Liters/hour | 20 to 45 min and 4 to 8 hours post injection |
|
|
|
| Primary | PK Analysis - Total Clearance (CL)/Body Weight (BW) | CL/BW = total clearance normalized by BW | PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples | Posted | Median | Full Range | Liters/hour/kg | 20 to 45 min and 4 to 8 hours post injection |
|
|
|
| Primary | PK Analysis - Volume of Distribution at Steady State (Vss) | Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state. | PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples | Posted | Median | Full Range | Liters | 20 to 45 min and 4 to 8 hours post injection |
|
|
|
| Primary | PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW) | Vss/BW = volume of distribution at steady state normalized by body weight | PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples | Posted | Median | Full Range | Liters/kg | 20 to 45 min and 4 to 8 hours post injection |
|
|
|
| Primary | PK Analysis - Area Under the Drug Concentration-time Curve (AUC) | AUC = Area under the drug concentration-time curve from administration to infinity | PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples | Posted | Median | Full Range | µmol•hour/Liter | Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity. |
|
|
|
| Primary | PK Analysis - t 1/2 | t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity | PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples | Posted | Median | Full Range | hour | Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity |
|
|
|
| Secondary | Number of Participants With Number of Lesions Detected - Stage 1 | BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions. | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Number of Lesions Detected - Stage 2 | BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions. | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Quality of Lesion Visualization - Stage 1 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible) | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Quality of Lesion Visualization - Stage 2 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible) | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Quality of Border Delineation - Stage 1 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Quality of Border Delineation - Stage 2 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
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| Secondary | Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 | BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 | The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
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|
| Secondary | Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2 | The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 | Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator. | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2 | Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Diagnostic Confidence - Stage 1 | The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Diagnostic Confidence - Stage 2 | The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Management Based on Unenhanced Images - Stage 1 | For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators. | Full analysis set (only participants for whom information on management was given) | Posted | Number | Participants | Within 5 minutes before injection |
|
|
|
| Secondary | Management Based on Unenhanced Images - Stage 2 | For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators. | Full analysis set (only participants for whom information on management was given) | Posted | Number | Participants | Within 5 minutes before injection |
|
|
|
| Secondary | Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1 | For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses. | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2 | For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1. | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 | The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1 | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| Secondary | Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 | The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1 | Full analysis set | Posted | Number | Participants | Within 5 minutes after injection |
|
|
|
| 4 |
| 20 |
| 6 |
| 20 |
| EG001 | Gadopentetate Dimeglumine - Stage 2 | Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). | 8 | 34 | 2 | 34 |
| Alagille syndrome | Congenital, familial and genetic disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Congenital aortic anomaly | Congenital, familial and genetic disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Intestinal cyst | Gastrointestinal disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA{13.0} | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA{13.0} | Non-systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA{13.0} | Non-systematic Assessment |
|
| Intracranial venous sinus thrombosis | Nervous system disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Motor developmental delay | Nervous system disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Adenoidectomy | Surgical and medical procedures | MedDRA{13.0} | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA{13.0} | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA{13.0} | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA{13.0} | Non-systematic Assessment |
|
Not provided
| D000085 |
| Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D056831 | Coordination Complexes |
| Title | Measurements |
|---|---|
|
| Reader 1, 0.1 mmol/kg |
|
| Reader 2, 0.1 mmol/kg |
|
| Reader 3, 0.1 mmol/kg |
|
| BR 3 - Diagnostic information |
|
| BR 1 - Contrast enhancement |
|
| BR 2 - Contrast enhancement |
|
| BR 3 - Contrast enhancement |
|
| BR 1 - Border delineation |
|
| BR 2 - Border delineation |
|
| BR 3 - Border delineation |
|
| BR 1 - Internal morphology |
|
| BR 2 - Internal morphology |
|
| BR 3 - Internal morphology |
|
| Title | Measurements |
|---|---|
|
| BR 3 - 0 lesions |
|
| CI - 0 lesions |
|
| BR 1 - 1 lesion |
|
| BR 2 - 1 lesion |
|
| BR 3 - 1 lesion |
|
| CI - 1 lesion |
|
| BR 1 - 2 lesions |
|
| BR 2 - 2 lesions |
|
| BR 3 - 2 lesions |
|
| CI - 2 lesions |
|
| BR 1 - 3 or more lesions |
|
| BR 2 - 3 or more lesions |
|
| BR 3 - 3 or more lesions |
|
| CI - 3 or more lesions |
|
| BR 3 - 0 lesions |
|
| CI - 0 lesions |
|
| BR 1 - 1 lesions |
|
| BR 2 - 1 lesions |
|
| BR 3 - 1 lesions |
|
| CI - 1 lesions |
|
| BR 1 - 2 lesions |
|
| BR 2 - 2 lesions |
|
| BR 3 - 2 lesions |
|
| CI - 2 lesions |
|
| BR 1 - 3 or more lesions |
|
| BR 2 - 3 or more lesions |
|
| BR 3 - 3 or more lesions |
|
| CI - 3 or more lesions |
|
|
| BR 3 - Excellent (1) |
|
| CI - Excellent (1) |
|
| BR 1 - Fair but adequate (2) |
|
| BR 2 - Fair but adequate (2) |
|
| BR 3 - Fair but adequate (2) |
|
| CI - Fair but adequate (2) |
|
| BR 1 - Poor (3) |
|
| BR 2 - Poor (3) |
|
| BR 3 - Poor (3) |
|
| CI - Poor (3) |
|
| BR 3 - Excellent (1) |
|
| CI - Excellent (1) |
|
| BR 1 - Fair but adequate (2) |
|
| BR 2 - Fair but adequate (2) |
|
| BR 3 - Fair but adequate (2) |
|
| CI - Fair but adequate (2) |
|
| BR 1 - Poor (3) |
|
| BR 2 - Poor (3) |
|
| BR 3 - Poor (3) |
|
| CI - Poor (3) |
|
|
| BR 3 - Excellent (1) |
|
| CI - Excellent (1) |
|
| BR 1 - Fair but adequate (2) |
|
| BR 2 - Fair but adequate (2) |
|
| BR 3 - Fair but adequate (2) |
|
| CI - Fair but adequate (2) |
|
| BR 1 - Poor (3) |
|
| BR 2 - Poor (3) |
|
| BR 3 - Poor (3) |
|
| CI - Poor (3) |
|
| BR 3 - Excellent (1) |
|
| CI - Excellent (1) |
|
| BR 1 - Fair but adequate (2) |
|
| BR 2 - Fair but adequate (2) |
|
| BR 3 - Fair but adequate (2) |
|
| CI - Fair but adequate (2) |
|
| BR 1 - Poor (3) |
|
| BR 2 - Poor (3) |
|
| BR 3 - Poor (3) |
|
| CI - Poor (3) |
|
| Title | Measurements |
|---|---|
|
| CI - No lesion |
|
| Reader 1 - Brain lesion |
|
| Reader 2 - Brain lesion |
|
| Reader 3 - Brain lesion |
|
| CI - Brain lesion |
|
| Title | Measurements |
|---|---|
|
| CI - No lesion |
|
| Reader 1 - Brain lesion |
|
| Reader 2 - Brain lesion |
|
| Reader 3 - Brain lesion |
|
| CI - Brain lesion |
|
| BR 3 |
|
| CI |
|
| Title | Measurements |
|---|
|
| CI |
|
| BR 3 - from "no lesion" to "vascular malformation" |
|
| BR 3 - from "no lesion" to "brain lesion" |
|
| BR 1 - from "vasc. malform." to "vasc. malfrom." |
|
| BR 1 - from "brain lesion" to "brain lesion" |
|
| BR 3 - from "brain lesion" to "brain lesion" |
|
| BR 1 - from "other" to "other" |
|
| BR 3 - from "other" to "vascular malformation" |
|
| BR 1 - from "metastasis" to "metastasis" |
|
| BR 3 - from "liver lesion" to "metastasis" |
|
| Title | Measurements |
|---|---|
|
| BR 3 - from "no lesion" to "infectious disorder" |
|
| BR 1 - from "vasc. malform." to "vasc. malform." |
|
| BR 1 - from "inf. disorder" to "inf. disorder" |
|
| BR 1 - from "brain lesion" to "no lesion" |
|
| BR 1 - from "brain lesion" to "inf. disorder" |
|
| BR 1 - from "brain lesion" to "brain lesion" |
|
| BR 2 - from "brain lesion" to "brain lesion" |
|
| BR 3 - from "brain lesion" to "brain lesion" |
|
| BR 2 - from "renal lesion" to "renal lesion" |
|
| BR 3 - from "renal lesion" to "renal lesion" |
|
| BR 3 - from "not assessable" to "other" |
|
| BR 1 - from "other" to "vascular malformation" |
|
| BR 2 - from "other" to "vascular malformation" |
|
| BR 2 - from "other" to "other" |
|
| BR 3 - from "other" to "other" |
|
|
| BR 3 - not confident |
|
| CI - not confident |
|
| BR 1 - confident |
|
| BR 2 - confident |
|
| BR 3 - confident |
|
| CI - confident |
|
| BR 1 - very confident |
|
| BR 2 - very confident |
|
| BR 3 - very confident |
|
| CI - very confident |
|
| BR 3 - not confident |
|
| CI - not confident |
|
| BR 1 - confident |
|
| BR 2 - confident |
|
| BR 3 - confident |
|
| CI - confident |
|
| BR 1 - very confident |
|
| BR 2 - very confident |
|
| BR 3 - very confident |
|
| CI - very confident |
|
| Title | Measurements |
|---|
|
| medical treatment |
|
| imaging |
|
| from "imaging" to "follow-up" |
|
| from "imaging" to "imaging" |
|
| from "imaging" to "other" |
|
| from "other" to "follow-up" |
|
| Title | Measurements |
|---|---|
|
| from "imaging" to "imaging" |
|
| from "imaging" to "other" |
|