Trial Outcomes & Findings for A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children (NCT NCT00468819)
NCT ID: NCT00468819
Last Updated: 2015-07-22
Results Overview
Total body clearance of Gadobutrol in plasma in L/h after intravenous injection.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
140 participants
Primary outcome timeframe
From injection of Gadobutrol up to 8 hours after injection.
Results posted on
2015-07-22
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
44
|
48
|
|
Overall Study
Treatment Received/ Safety Follow-up
|
46
|
44
|
48
|
|
Overall Study
COMPLETED
|
42
|
44
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Drop-outs (Treatment never received)
|
2
|
0
|
0
|
Baseline Characteristics
A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children
Baseline characteristics by cohort
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.7 years
STANDARD_DEVIATION 1.46 • n=5 Participants
|
9.0 years
STANDARD_DEVIATION 1.38 • n=7 Participants
|
14.7 years
STANDARD_DEVIATION 1.80 • n=5 Participants
|
9.2 years
STANDARD_DEVIATION 4.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Body Weight
|
17.49 kg
STANDARD_DEVIATION 5.434 • n=5 Participants
|
33.75 kg
STANDARD_DEVIATION 8.956 • n=7 Participants
|
57.19 kg
STANDARD_DEVIATION 14.245 • n=5 Participants
|
36.48 kg
STANDARD_DEVIATION 19.447 • n=4 Participants
|
PRIMARY outcome
Timeframe: From injection of Gadobutrol up to 8 hours after injection.Population: Final pharmacokinetics (PK) analysis set
Total body clearance of Gadobutrol in plasma in L/h after intravenous injection.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=45 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=39 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=130 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Plasma Clearance Estimates of Gadobutrol by Age Group
|
2.07 L/h
Interval 1.45 to 3.83
|
3.28 L/h
Interval 1.81 to 5.93
|
4.90 L/h
Interval 2.52 to 7.37
|
3.24 L/h
Interval 1.53 to 6.62
|
PRIMARY outcome
Timeframe: From injection up to 8 hours after Gadobutrol injectionPopulation: Final PK analysis set
Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=45 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=39 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=130 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group
|
0.13 L/h/kg
Interval 0.09 to 0.17
|
0.10 L/h/kg
Interval 0.05 to 0.17
|
0.09 L/h/kg
Interval 0.05 to 0.1
|
0.10 L/h/kg
Interval 0.05 to 0.17
|
PRIMARY outcome
Timeframe: From injection up to 8 hours after Gadobutrol injectionPopulation: Final PK analysis set
Apparent volume of distribution at steady state expressed in L after intravenous injection.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=45 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=39 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=130 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group
|
3.83 L
Interval 3.24 to 6.33
|
5.98 L
Interval 4.06 to 11.69
|
10.02 L
Interval 5.16 to 14.12
|
5.96 L
Interval 3.27 to 13.21
|
PRIMARY outcome
Timeframe: From injection to 8 hours after Gadobutrol injectionPopulation: Final PK analysis set
Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=45 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=39 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=130 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group
|
0.24 L/kg
Interval 0.2 to 0.28
|
0.19 L/kg
Interval 0.14 to 0.23
|
0.18 L/kg
Interval 0.09 to 0.23
|
0.20 L/kg
Interval 0.12 to 0.28
|
PRIMARY outcome
Timeframe: From injection to 8 hours after Gadobutrol injectionPopulation: Final PK analysis set
Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol\*h/L.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=45 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=39 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=130 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group
|
815 µmol*h/L
Interval 494.0 to 1167.0
|
969 µmol*h/L
Interval 590.0 to 2163.0
|
1167 µmol*h/L
Interval 925.0 to 1808.0
|
999 µmol*h/L
Interval 590.0 to 1808.0
|
PRIMARY outcome
Timeframe: From injection to 8 hours after Gadobutrol injectionPopulation: Final PK analysis set
Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=45 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=39 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=130 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Terminal Elimination Half Life Estimates of Gadobutrol by Age Group
|
1.75 hours
Interval 1.34 to 2.3
|
1.61 hours
Interval 1.17 to 2.62
|
1.65 hours
Interval 1.42 to 2.23
|
1.69 hours
Interval 1.34 to 2.32
|
PRIMARY outcome
Timeframe: From injection to 8 hours after Gadobutrol injectionPopulation: Final PK analysis set
Mean residence time of Gadobutrol in plasma expressed in h.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=45 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=39 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=130 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group
|
1.88 hours
Interval 1.24 to 2.77
|
1.83 hours
Interval 1.03 to 3.37
|
2.03 hours
Interval 1.57 to 2.99
|
1.94 hours
Interval 1.24 to 2.99
|
SECONDARY outcome
Timeframe: up to 6 hours after Gadobutrol injectionPopulation: Valid for urinary analysis
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.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=22 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=34 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=41 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=97 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Urinary Excretion of Gadolinium as Percent of Administered Dose
|
93.78 percentage of administered dose
Interval 9.19 to 187.73
|
92.14 percentage of administered dose
Interval 18.96 to 117.18
|
95.96 percentage of administered dose
Interval 3.48 to 139.03
|
94.13 percentage of administered dose
Interval 3.48 to 187.73
|
SECONDARY outcome
Timeframe: Up to 1 hour after Gadobutrol injectionPopulation: FAS
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).
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group
not adequate (compromised quality)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group
partially adequate (evaluation possible)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group
adequate despite artifacts
|
12 Participants
|
13 Participants
|
14 Participants
|
39 Participants
|
|
Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group
adequate with excellent quality
|
34 Participants
|
31 Participants
|
33 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: up to 1 hour after Gadobutrol injectionPopulation: FAS
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).
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
none
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
poor
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
moderate
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
good
|
9 Participants
|
17 Participants
|
13 Participants
|
39 Participants
|
|
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
excellent
|
37 Participants
|
27 Participants
|
32 Participants
|
96 Participants
|
|
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
not assessable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 1 hour after Gadobutrol injectionPopulation: FAS
Number of lesions on pre-contrast images by organ location and age group.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Pre-Contrast Lesions by Location and by Age Group
Kidney
|
5 Lesions
|
0 Lesions
|
8 Lesions
|
13 Lesions
|
|
Pre-Contrast Lesions by Location and by Age Group
Liver
|
0 Lesions
|
0 Lesions
|
0 Lesions
|
0 Lesions
|
|
Pre-Contrast Lesions by Location and by Age Group
Brain
|
34 Lesions
|
32 Lesions
|
30 Lesions
|
96 Lesions
|
|
Pre-Contrast Lesions by Location and by Age Group
Vessel
|
0 Lesions
|
0 Lesions
|
0 Lesions
|
0 Lesions
|
|
Pre-Contrast Lesions by Location and by Age Group
Spine
|
7 Lesions
|
2 Lesions
|
1 Lesions
|
10 Lesions
|
SECONDARY outcome
Timeframe: up to 1 hour after Gadobutrol injectionPopulation: FAS
Number of lesions on post-contrast images by organ location and age group.
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Post-Contrast Lesions by Location and by Age Group
Kidney
|
6 Lesions
|
0 Lesions
|
5 Lesions
|
11 Lesions
|
|
Post-Contrast Lesions by Location and by Age Group
Liver
|
0 Lesions
|
0 Lesions
|
0 Lesions
|
0 Lesions
|
|
Post-Contrast Lesions by Location and by Age Group
Brain
|
33 Lesions
|
32 Lesions
|
34 Lesions
|
99 Lesions
|
|
Post-Contrast Lesions by Location and by Age Group
Vessel
|
0 Lesions
|
0 Lesions
|
2 Lesions
|
2 Lesions
|
|
Post-Contrast Lesions by Location and by Age Group
Spine
|
7 Lesions
|
2 Lesions
|
1 Lesions
|
10 Lesions
|
SECONDARY outcome
Timeframe: up to 1 hour after Gadobutrol injectionPopulation: FAS
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).
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Pre-Contrast Delineation of Lesion/Vessel Border by Age Group
no
|
3 Lesions
|
0 Lesions
|
1 Lesions
|
4 Lesions
|
|
Pre-Contrast Delineation of Lesion/Vessel Border by Age Group
moderate
|
5 Lesions
|
0 Lesions
|
5 Lesions
|
10 Lesions
|
|
Pre-Contrast Delineation of Lesion/Vessel Border by Age Group
good
|
20 Lesions
|
20 Lesions
|
15 Lesions
|
55 Lesions
|
|
Pre-Contrast Delineation of Lesion/Vessel Border by Age Group
excellent
|
18 Lesions
|
14 Lesions
|
18 Lesions
|
50 Lesions
|
|
Pre-Contrast Delineation of Lesion/Vessel Border by Age Group
not assessable
|
0 Lesions
|
0 Lesions
|
0 Lesions
|
0 Lesions
|
SECONDARY outcome
Timeframe: up to 1 hour after Gadobutrol injectionPopulation: FAS
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).
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Post-Contrast Delineation of Lesion/Vessel Border by Age Group
no
|
0 Lesions
|
0 Lesions
|
5 Lesions
|
5 Lesions
|
|
Post-Contrast Delineation of Lesion/Vessel Border by Age Group
moderate
|
0 Lesions
|
4 Lesions
|
7 Lesions
|
11 Lesions
|
|
Post-Contrast Delineation of Lesion/Vessel Border by Age Group
good
|
14 Lesions
|
10 Lesions
|
10 Lesions
|
34 Lesions
|
|
Post-Contrast Delineation of Lesion/Vessel Border by Age Group
excellent
|
30 Lesions
|
20 Lesions
|
19 Lesions
|
69 Lesions
|
|
Post-Contrast Delineation of Lesion/Vessel Border by Age Group
not assessable
|
2 Lesions
|
0 Lesions
|
1 Lesions
|
3 Lesions
|
SECONDARY outcome
Timeframe: up to 1 hour after Gadobutrol injectionPopulation: FAS
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).
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Pre-Contrast Lesion Characterization by Age Group
poor
|
3 Lesions
|
1 Lesions
|
2 Lesions
|
6 Lesions
|
|
Pre-Contrast Lesion Characterization by Age Group
moderate
|
6 Lesions
|
6 Lesions
|
6 Lesions
|
18 Lesions
|
|
Pre-Contrast Lesion Characterization by Age Group
good
|
36 Lesions
|
27 Lesions
|
30 Lesions
|
93 Lesions
|
|
Pre-Contrast Lesion Characterization by Age Group
not applicable
|
1 Lesions
|
0 Lesions
|
1 Lesions
|
2 Lesions
|
SECONDARY outcome
Timeframe: up to 1 hour after Gadobutrol injectionPopulation: FAS
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).
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Post-Contrast Lesion Characterization by Age Group
poor
|
1 Lesions
|
0 Lesions
|
6 Lesions
|
7 Lesions
|
|
Post-Contrast Lesion Characterization by Age Group
moderate
|
2 Lesions
|
3 Lesions
|
6 Lesions
|
11 Lesions
|
|
Post-Contrast Lesion Characterization by Age Group
good
|
42 Lesions
|
31 Lesions
|
25 Lesions
|
98 Lesions
|
|
Post-Contrast Lesion Characterization by Age Group
not applicable
|
1 Lesions
|
0 Lesions
|
5 Lesions
|
6 Lesions
|
SECONDARY outcome
Timeframe: up to 1 hour after Gadobutrol injectionPopulation: FAS
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).
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)
good
|
3 Lesions
|
4 Lesions
|
2 Lesions
|
9 Lesions
|
|
Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)
excellent
|
20 Lesions
|
10 Lesions
|
16 Lesions
|
46 Lesions
|
|
Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)
not applicable
|
3 Lesions
|
0 Lesions
|
2 Lesions
|
5 Lesions
|
|
Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)
no
|
19 Lesions
|
19 Lesions
|
18 Lesions
|
56 Lesions
|
|
Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)
moderate
|
1 Lesions
|
1 Lesions
|
4 Lesions
|
6 Lesions
|
SECONDARY outcome
Timeframe: up to 1 hour after Gadobutrol injectionPopulation: FAS
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).
Outcome measures
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 Participants
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Number of Participants With Change in Diagnostic Confidence by Age Group
missing
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change in Diagnostic Confidence by Age Group
unchanged
|
3 Participants
|
3 Participants
|
5 Participants
|
11 Participants
|
|
Number of Participants With Change in Diagnostic Confidence by Age Group
worsened
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Diagnostic Confidence by Age Group
improved
|
43 Participants
|
41 Participants
|
42 Participants
|
126 Participants
|
Adverse Events
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 participants at risk
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 participants at risk
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 participants at risk
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 participants at risk
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Infections and infestations
Meningitis
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Infections and infestations
Pneumonia
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Investigations
Crystal urine
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
Other adverse events
| Measure |
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years
n=46 participants at risk
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years
n=44 participants at risk
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years
n=48 participants at risk
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years
n=138 participants at risk
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/46
|
0.00%
0/44
|
2.1%
1/48
|
0.72%
1/138
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/46
|
2.3%
1/44
|
2.1%
1/48
|
2.2%
3/138
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/46
|
0.00%
0/44
|
2.1%
1/48
|
0.72%
1/138
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/46
|
0.00%
0/44
|
4.2%
2/48
|
1.4%
2/138
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46
|
2.3%
1/44
|
6.2%
3/48
|
3.6%
5/138
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/46
|
0.00%
0/44
|
4.2%
2/48
|
1.4%
2/138
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
2/46
|
4.5%
2/44
|
2.1%
1/48
|
3.6%
5/138
|
|
General disorders
Chest pain
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
|
General disorders
Feeling hot
|
0.00%
0/46
|
0.00%
0/44
|
4.2%
2/48
|
1.4%
2/138
|
|
General disorders
Pyrexia
|
4.3%
2/46
|
4.5%
2/44
|
2.1%
1/48
|
3.6%
5/138
|
|
Infections and infestations
Bronchitis
|
0.00%
0/46
|
2.3%
1/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Infections and infestations
Gastroenteritis
|
4.3%
2/46
|
2.3%
1/44
|
0.00%
0/48
|
2.2%
3/138
|
|
Infections and infestations
Gastrointestinal infection
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/46
|
2.3%
1/44
|
2.1%
1/48
|
1.4%
2/138
|
|
Infections and infestations
Otitis media
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Infections and infestations
Rhinitis
|
0.00%
0/46
|
2.3%
1/44
|
2.1%
1/48
|
1.4%
2/138
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/46
|
2.3%
1/44
|
0.00%
0/48
|
1.4%
2/138
|
|
Infections and infestations
Central line infection
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Infections and infestations
Oral herpes
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Injury, poisoning and procedural complications
Head injury
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Investigations
Oxygen saturation decreased
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/46
|
4.5%
2/44
|
2.1%
1/48
|
2.2%
3/138
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/46
|
0.00%
0/44
|
2.1%
1/48
|
0.72%
1/138
|
|
Nervous system disorders
Dizziness
|
0.00%
0/46
|
0.00%
0/44
|
2.1%
1/48
|
0.72%
1/138
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/46
|
0.00%
0/44
|
4.2%
2/48
|
1.4%
2/138
|
|
Nervous system disorders
Headache
|
0.00%
0/46
|
4.5%
2/44
|
4.2%
2/48
|
2.9%
4/138
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/46
|
0.00%
0/44
|
2.1%
1/48
|
0.72%
1/138
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/46
|
0.00%
0/44
|
2.1%
1/48
|
0.72%
1/138
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/46
|
0.00%
0/44
|
2.1%
1/48
|
0.72%
1/138
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/46
|
0.00%
0/44
|
2.1%
1/48
|
0.72%
1/138
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
1/46
|
0.00%
0/44
|
0.00%
0/48
|
0.72%
1/138
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/46
|
0.00%
0/44
|
2.1%
1/48
|
0.72%
1/138
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/46
|
0.00%
0/44
|
2.1%
1/48
|
1.4%
2/138
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60