Introduction
Materials and methods
Ethical approval
Participants
Country | Total number of pediatric patients (n, % by region) |
---|---|
Asia
|
425 (37.2) |
China | 156 (36.7) |
Kazakhstan & Kyrgyzstan | 144 (33.9) |
Korea | 108 (25.4) |
Taiwan | 16 (3.8) |
Thailand | 1 (0.2) |
Europe
|
650 (56.9) |
Bosnia & Herzegovina | 28 (4.3) |
Czech Republic | 6 (0.9) |
France | 9 (1.4) |
Germany | 465 (71.5) |
Greece | 8 (1.2) |
Hungary | 2 (0.3) |
Italy | 17 (2.6) |
Russia | 101 (15.5) |
Spain | 14 (2.2) |
Other regions
|
67 (5.9) |
Canada | 63 (94.0) |
South Africa | 4 (6.0) |
Outcome measures
Statistical analyses
Results
Baseline demographics
Demographic data |
N (%) pediatric patients/median values | |
---|---|---|
Total patients | 1,142 | |
Gender (n, %) | Male | 604 (52.9) |
Female | 538 (47.1) | |
Age groups (n [%], years) | <18 years (total) | 1,142 (100) |
<2 years | 4 (0.4) | |
2 – <7 years | 168 (14.7) | |
7 – <18 years | 970 (84.9) | |
Body weight (median, kg) | <18 years (total) | 45.0 |
<2 years | 9.5 | |
2 – <7 years | 18.5 | |
7 – <18 years | 50.0 | |
BMI (median, kg/m2) | <18 years (total) | 19.0 |
<2 years | 19.1 | |
2 – <7 years | 15.7 | |
7 – <18 years | 19.7 | |
At least 1 contrast medium risk factor (n [% of age subgroup]) | <18 years (total) | 95 (8.3) |
<2 years | 0 | |
2 – <7 years | 12 (7.1) | |
7 – <18 years | 83 (8.6) | |
Types of risk for contrast medium reaction (n, %) | Allergy | 81 (7.1) |
Bronchial/asthma | 25 (2.2) | |
Previous contrast medium reaction | 1 (0.1) |
Gadobutrol dose details
Dose group (mmol/kg body weight) | <2 years, n (%) | 2 – <7 years, n (%) | 7 – <18 years, n (%) | Total, N (%) |
---|---|---|---|---|
≤0.1 | 0 | 88 (52.4) | 422 (43.5) | 510 (44.7) |
>0.1 – 0.2 | 3 (75.0) | 64 (38.1) | 484 (49.9) | 551 (48.3) |
>0.2 – 0.3 | 0 | 10 (6.0) | 57 (5.9) | 67 (5.9) |
>0.3a
| 1 (25.0) | 6 (3.6) | 7 (0.7) | 14 (1.2) |
Total | 4 (100) | 168 (100) | 970 (100) | 1,142 (100) |
Adverse events (primary endpoint)
Patient (gender/age [years]) | AE/ADR | Dose (mmol gadolinium/kg body weight) | Relationship with drug | Severity |
---|---|---|---|---|
Female/17 | Nausea and vomiting | 0.11 | Yes | Mild |
Male/6 | Vomiting | 0.13 | Yes | Moderate |
Male/13 | Nausea | 0.11 | Yes | Mild |
Female/15 | Eyelid edema | 0.10 | Yes | Moderate |
Female/5 | Urticaria | 0.11 | Yes | Moderate |
Female/14 | Injection-site reaction | 0.11 | Yes | Mild |
Female/5 | Vomiting after 15 min | 0.10 | No | Mild |
Male/13 | Dyspnea after 24 h | 0.10 | No | Mild |