Table 4.
Adverse events
| Number of patients with adverse events, irrespective of causality | Number of patients with adverse events possibly or probably related to study drug | |||
|---|---|---|---|---|
| Adverse event | European/Brazilian study (n = 16) | North American study (n = 6) | European/Brazilian study (n = 16) | North American study (n = 6) |
| Injection-site reaction | 15 | 6 | 15 | 6 |
| Upper respiratory infection | 10 | 4 | – | – |
| Rhinitis | 9 | 2 | – | – |
| Gastrointestinal disorder | 6 | 4 | – | 1 |
| Headache | 6 | 4 | – | 3 |
| Conjunctivitis | 6 | 3 | – | – |
| Fever | 6 | 3 | 1 | – |
| Infection | 5 | 3 | – | – |
| Bronchitis | 4 | 1 | – | – |
| Otitis media | 4 | 1 | – | – |
| Pharyngitis | 4 | 1 | – | – |
| Sinusitis | 2 | 3 | – | – |
| Accidental injury | 3 | – | – | – |
| Laryngitis | 3 | – | – | – |
| Leucopenia | 2 | – | – | – |
| Lymphadenopathy | 2 | – | – | – |
| Asthma | – | 2 | – | – |
| Nausea | – | 2 | – | 2 |
| Skin disorder | 2 | – | – | – |
Table summarizes adverse events occurring in two or more children in either study. In addition, the following possibly or probably related adverse events occurred in one subject each in the North American study: nervousness, rash, syncope and urine abnormality. n: number of patients treated with Vivaglobin.