Magnetic Resonance Imaging
Conditions
Keywords
Contrast-enhanced MRI, MR angiography (MRA) Children 2-17 years
Brief summary
In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.
Detailed description
Please note that the present study is allocated two study phases, i.e. phase I and phase III.
Interventions
In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients (male/ female) of specific age groups (2-6 years, 7-11 years, 12-17 years) who are scheduled to undergo Gadolinium (Gd)-enhanced MRI of brain, spine, liver and/or kidneys or Gd-enhanced MRA (single field of view).
Exclusion criteria
* Clinically unstable patients (e.g. intensive care unit) * Renal insufficiency * Patients undergoing a relevant change in chemotherapy \</= 48 hours prior to and up to 24 hours after the administration of Gadovist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Clearance Estimates of Gadobutrol by Age Group | From injection of Gadobutrol up to 8 hours after injection. | Total body clearance of Gadobutrol in plasma in L/h after intravenous injection. |
| Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group | From injection up to 8 hours after Gadobutrol injection | Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection. |
| Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | From injection up to 8 hours after Gadobutrol injection | Apparent volume of distribution at steady state expressed in L after intravenous injection. |
| Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | From injection to 8 hours after Gadobutrol injection | Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection. |
| Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group | From injection to 8 hours after Gadobutrol injection | Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol\*h/L. |
| Terminal Elimination Half Life Estimates of Gadobutrol by Age Group | From injection to 8 hours after Gadobutrol injection | Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve. |
| Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group | From injection to 8 hours after Gadobutrol injection | Mean residence time of Gadobutrol in plasma expressed in h. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Contrast Lesion Characterization by Age Group | up to 1 hour after Gadobutrol injection | In the participants the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable). |
| Post-Contrast Lesion Characterization by Age Group | up to 1 hour after Gadobutrol injection | In the participants the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable). |
| Urinary Excretion of Gadolinium as Percent of Administered Dose | up to 6 hours after Gadobutrol injection | Amount of gadolinium\* excreted into urine during the collection interval 0 - 6 h post dose expressed as % of administered dose. \*A metallic rare-earth element, used as a contrast medium for magnetic resonance imaging. |
| Number of Participants With Change in Diagnostic Confidence by Age Group | up to 1 hour after Gadobutrol injection | In the participants the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened). |
| Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | up to 1 hour after Gadobutrol injection | In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable). |
| Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | Up to 1 hour after Gadobutrol injection | In the participants the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate \[compromised quality\], 2=partially adequate \[evaluation possible\], 3=adequate despite artifacts, 4=adequate with excellent quality). |
| Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | up to 1 hour after Gadobutrol injection | In the participants qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable). |
| Pre-Contrast Lesions by Location and by Age Group | up to 1 hour after Gadobutrol injection | Number of lesions on pre-contrast images by organ location and age group. |
| Post-Contrast Lesions by Location and by Age Group | up to 1 hour after Gadobutrol injection | Number of lesions on post-contrast images by organ location and age group. |
| Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | up to 1 hour after Gadobutrol injection | In the participants pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable). |
| Post-Contrast Delineation of Lesion/Vessel Border by Age Group | up to 1 hour after Gadobutrol injection | In the participants post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable). |
Countries
Austria, Canada, Germany, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection | 46 |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection | 44 |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection | 48 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Drop-outs (Treatment never received) | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 1 |
Baseline characteristics
| Characteristic | Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Total |
|---|---|---|---|---|
| Age, Continuous | 3.7 years STANDARD_DEVIATION 1.46 | 9.0 years STANDARD_DEVIATION 1.38 | 14.7 years STANDARD_DEVIATION 1.8 | 9.2 years STANDARD_DEVIATION 4.83 |
| Body Weight | 17.49 kg STANDARD_DEVIATION 5.434 | 33.75 kg STANDARD_DEVIATION 8.956 | 57.19 kg STANDARD_DEVIATION 14.245 | 36.48 kg STANDARD_DEVIATION 19.447 |
| Sex: Female, Male Female | 17 Participants | 13 Participants | 23 Participants | 53 Participants |
| Sex: Female, Male Male | 29 Participants | 31 Participants | 25 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 46 | 16 / 44 | 16 / 48 | 49 / 138 |
| serious Total, serious adverse events | 1 / 46 | 1 / 44 | 0 / 48 | 2 / 138 |
Outcome results
Primary
Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group
Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol\*h/L.
Time frame: From injection to 8 hours after Gadobutrol injection
Population: Final PK analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group | 815 µmol*h/L |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group | 969 µmol*h/L |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group | 1167 µmol*h/L |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group | 999 µmol*h/L |
Primary
Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group
Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection.
Time frame: From injection up to 8 hours after Gadobutrol injection
Population: Final PK analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group | 0.13 L/h/kg |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group | 0.10 L/h/kg |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group | 0.09 L/h/kg |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group | 0.10 L/h/kg |
Primary
Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group
Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection.
Time frame: From injection to 8 hours after Gadobutrol injection
Population: Final PK analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | 0.24 L/kg |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | 0.19 L/kg |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | 0.18 L/kg |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | 0.20 L/kg |
Primary
Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group
Mean residence time of Gadobutrol in plasma expressed in h.
Time frame: From injection to 8 hours after Gadobutrol injection
Population: Final PK analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group | 1.88 hours |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group | 1.83 hours |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group | 2.03 hours |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group | 1.94 hours |
Primary
Plasma Clearance Estimates of Gadobutrol by Age Group
Total body clearance of Gadobutrol in plasma in L/h after intravenous injection.
Time frame: From injection of Gadobutrol up to 8 hours after injection.
Population: Final pharmacokinetics (PK) analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Plasma Clearance Estimates of Gadobutrol by Age Group | 2.07 L/h |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Plasma Clearance Estimates of Gadobutrol by Age Group | 3.28 L/h |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Plasma Clearance Estimates of Gadobutrol by Age Group | 4.90 L/h |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Plasma Clearance Estimates of Gadobutrol by Age Group | 3.24 L/h |
Primary
Terminal Elimination Half Life Estimates of Gadobutrol by Age Group
Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve.
Time frame: From injection to 8 hours after Gadobutrol injection
Population: Final PK analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Terminal Elimination Half Life Estimates of Gadobutrol by Age Group | 1.75 hours |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Terminal Elimination Half Life Estimates of Gadobutrol by Age Group | 1.61 hours |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Terminal Elimination Half Life Estimates of Gadobutrol by Age Group | 1.65 hours |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Terminal Elimination Half Life Estimates of Gadobutrol by Age Group | 1.69 hours |
Primary
Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group
Apparent volume of distribution at steady state expressed in L after intravenous injection.
Time frame: From injection up to 8 hours after Gadobutrol injection
Population: Final PK analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | 3.83 L |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | 5.98 L |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | 10.02 L |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | 5.96 L |
Secondary
Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)
In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable).
Time frame: up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | excellent | 20 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | moderate | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | not applicable | 3 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | good | 3 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | no | 19 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | good | 4 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | excellent | 10 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | not applicable | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | moderate | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | no | 19 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | good | 2 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | no | 18 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | moderate | 4 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | excellent | 16 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | not applicable | 2 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | excellent | 46 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | moderate | 6 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | no | 56 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | good | 9 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | not applicable | 5 Lesions |
Secondary
Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group
In the participants the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate \[compromised quality\], 2=partially adequate \[evaluation possible\], 3=adequate despite artifacts, 4=adequate with excellent quality).
Time frame: Up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | adequate despite artifacts | 12 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | partially adequate (evaluation possible) | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | not adequate (compromised quality) | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | adequate with excellent quality | 34 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | partially adequate (evaluation possible) | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | not adequate (compromised quality) | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | adequate despite artifacts | 13 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | adequate with excellent quality | 31 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | not adequate (compromised quality) | 1 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | adequate with excellent quality | 33 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | adequate despite artifacts | 14 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | partially adequate (evaluation possible) | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | partially adequate (evaluation possible) | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | adequate with excellent quality | 98 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | not adequate (compromised quality) | 1 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | adequate despite artifacts | 39 Participants |
Secondary
Number of Participants With Change in Diagnostic Confidence by Age Group
In the participants the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened).
Time frame: up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | missing | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | unchanged | 3 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | improved | 43 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | worsened | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | unchanged | 3 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | improved | 41 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | worsened | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | missing | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | improved | 42 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | unchanged | 5 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | worsened | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | missing | 1 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | worsened | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | unchanged | 11 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | missing | 1 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Change in Diagnostic Confidence by Age Group | improved | 126 Participants |
Secondary
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
In the participants qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable).
Time frame: up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | moderate | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | not assessable | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | poor | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | excellent | 37 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | none | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | good | 9 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | excellent | 27 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | good | 17 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | none | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | poor | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | moderate | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | not assessable | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | good | 13 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | none | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | poor | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | moderate | 3 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | excellent | 32 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | not assessable | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | not assessable | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | excellent | 96 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | none | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | good | 39 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | moderate | 3 Participants |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | poor | 0 Participants |
Secondary
Post-Contrast Delineation of Lesion/Vessel Border by Age Group
In the participants post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).
Time frame: up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | good | 14 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | excellent | 30 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | moderate | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | no | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | not assessable | 2 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | not assessable | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | excellent | 20 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | moderate | 4 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | no | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | good | 10 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | good | 10 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | no | 5 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | moderate | 7 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | excellent | 19 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | not assessable | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | excellent | 69 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | moderate | 11 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | no | 5 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | good | 34 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | not assessable | 3 Lesions |
Secondary
Post-Contrast Lesion Characterization by Age Group
In the participants the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).
Time frame: up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Lesion Characterization by Age Group | poor | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Lesion Characterization by Age Group | good | 42 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Lesion Characterization by Age Group | moderate | 2 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Lesion Characterization by Age Group | not applicable | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Lesion Characterization by Age Group | moderate | 3 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Lesion Characterization by Age Group | poor | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Lesion Characterization by Age Group | not applicable | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Lesion Characterization by Age Group | good | 31 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Lesion Characterization by Age Group | moderate | 6 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Lesion Characterization by Age Group | good | 25 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Lesion Characterization by Age Group | poor | 6 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Lesion Characterization by Age Group | not applicable | 5 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Lesion Characterization by Age Group | moderate | 11 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Lesion Characterization by Age Group | poor | 7 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Lesion Characterization by Age Group | not applicable | 6 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Lesion Characterization by Age Group | good | 98 Lesions |
Secondary
Post-Contrast Lesions by Location and by Age Group
Number of lesions on post-contrast images by organ location and age group.
Time frame: up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Lesions by Location and by Age Group | Brain | 33 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Lesions by Location and by Age Group | Kidney | 6 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Lesions by Location and by Age Group | Spine | 7 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Lesions by Location and by Age Group | Liver | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Post-Contrast Lesions by Location and by Age Group | Vessel | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Lesions by Location and by Age Group | Liver | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Lesions by Location and by Age Group | Brain | 32 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Lesions by Location and by Age Group | Vessel | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Lesions by Location and by Age Group | Kidney | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Post-Contrast Lesions by Location and by Age Group | Spine | 2 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Brain | 34 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Kidney | 5 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Liver | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Vessel | 2 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Spine | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Vessel | 2 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Kidney | 11 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Brain | 99 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Liver | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Post-Contrast Lesions by Location and by Age Group | Spine | 10 Lesions |
Secondary
Pre-Contrast Delineation of Lesion/Vessel Border by Age Group
In the participants pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).
Time frame: up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | excellent | 18 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | moderate | 5 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | not assessable | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | good | 20 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | no | 3 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | good | 20 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | excellent | 14 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | not assessable | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | moderate | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | no | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | good | 15 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | no | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | moderate | 5 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | excellent | 18 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | not assessable | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | excellent | 50 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | moderate | 10 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | no | 4 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | good | 55 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | not assessable | 0 Lesions |
Secondary
Pre-Contrast Lesion Characterization by Age Group
In the participants the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).
Time frame: up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Lesion Characterization by Age Group | poor | 3 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Lesion Characterization by Age Group | not applicable | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Lesion Characterization by Age Group | moderate | 6 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Lesion Characterization by Age Group | good | 36 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Lesion Characterization by Age Group | not applicable | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Lesion Characterization by Age Group | moderate | 6 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Lesion Characterization by Age Group | good | 27 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Lesion Characterization by Age Group | poor | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Lesion Characterization by Age Group | moderate | 6 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Lesion Characterization by Age Group | poor | 2 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Lesion Characterization by Age Group | good | 30 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Lesion Characterization by Age Group | not applicable | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Lesion Characterization by Age Group | good | 93 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Lesion Characterization by Age Group | moderate | 18 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Lesion Characterization by Age Group | poor | 6 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Lesion Characterization by Age Group | not applicable | 2 Lesions |
Secondary
Pre-Contrast Lesions by Location and by Age Group
Number of lesions on pre-contrast images by organ location and age group.
Time frame: up to 1 hour after Gadobutrol injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Lesions by Location and by Age Group | Kidney | 5 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Lesions by Location and by Age Group | Vessel | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Lesions by Location and by Age Group | Liver | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Lesions by Location and by Age Group | Brain | 34 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Pre-Contrast Lesions by Location and by Age Group | Spine | 7 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Lesions by Location and by Age Group | Liver | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Lesions by Location and by Age Group | Brain | 32 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Lesions by Location and by Age Group | Spine | 2 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Lesions by Location and by Age Group | Vessel | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Pre-Contrast Lesions by Location and by Age Group | Kidney | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Kidney | 8 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Liver | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Spine | 1 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Brain | 30 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Vessel | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Vessel | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Brain | 96 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Liver | 0 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Spine | 10 Lesions |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Pre-Contrast Lesions by Location and by Age Group | Kidney | 13 Lesions |
Secondary
Urinary Excretion of Gadolinium as Percent of Administered Dose
Amount of gadolinium\* excreted into urine during the collection interval 0 - 6 h post dose expressed as % of administered dose. \*A metallic rare-earth element, used as a contrast medium for magnetic resonance imaging.
Time frame: up to 6 hours after Gadobutrol injection
Population: Valid for urinary analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Urinary Excretion of Gadolinium as Percent of Administered Dose | 93.78 percentage of administered dose |
| Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Urinary Excretion of Gadolinium as Percent of Administered Dose | 92.14 percentage of administered dose |
| Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Urinary Excretion of Gadolinium as Percent of Administered Dose | 95.96 percentage of administered dose |
| Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Urinary Excretion of Gadolinium as Percent of Administered Dose | 94.13 percentage of administered dose |