Table 5:
Adverse reactions*‡ in ≥5% of pediatric and adult patients and rate per infusion (both studies)
| Preferred Term | Children (≥2 to <17 years) | Adults (≥ 17 years) | ||
|---|---|---|---|---|
| Number (%) of patients (N = 38) |
Number (rate†) of ARs (N = 3283 infusions) |
Number (%) of patients (N = 43) |
Number (rate†) of ARs (N = 3956 infusions) |
|
| Local reaction | 28 (73.7) | 442 (0.14) | 31 (72.1) | 648 (0.16) |
| Systemic ARs | ||||
| Asthma | 4 (10.5) | 7 (0.002) | – | – |
| Cough | 4 (10.5) | 5 (0.002) | – | – |
| Vomiting | 4 (10.5) | 5 (0.002) | – | – |
| Nasal congestion | 3 (7.9) | 4 (0.001) | – | – |
| Fever | 3 (7.9) | 4 (0.001) | 5 (11.6) | 5 (0.001) |
| Headache | 3 (7.9) | 3 (0.001) | 8 (18.6) | 10 (0.002) |
| ALT increased | 3 (7.9) | 3 (0.001) | – | – |
| Leukopenia | 3 (7.9) | 3 (0.001) | – | – |
| Neutropenia | 3 (7.9) | 3 (0.001) | – | – |
| Dermatitis | 2 (5.3) | 3 (0.001) | 5 (11.6) | 6 (0.001) |
| Oropharyngeal pain | 2 (5.3) | 3 (0.001) | – | – |
| Urticaria | 2 (5.3) | 2 (0.001) | – | – |
| AST increased | 2 (5.3) | 2 (0.001) | – | – |
| Abdominal pain | 2 (5.3) | 2 (0.001) | – | – |
| Ear pain | 2 (5.3) | 2 (0.001) | – | – |
| Diarrhea | – | – | 5 (11.6) | 7 (0.002) |
| Muscle spasms | – | – | 4 (9.3) | 5 (0.001) |
| Back pain | – | – | 4 (9.3) | 4 (0.001) |
*Excluding infections.
‡Adverse reactions were defined as adverse events occurring during or within 72 h of infusion or any adverse events otherwise causally related.
†Rate = total number of adverse reactions divided by total number of infusions.
ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; N, number of patients who experienced an AR that was experienced by ≥5% of the respective population.