Adverse reactions occurring in at least 15% of patients less than 18 years of age enrolled in aHUS study C09-001R
| <2 years (n=5) | 2 to <12 years (n=10) | 12 to <18 years (n=4) | Total (n=19) | |
|---|---|---|---|---|
| Fever | 4 (80) | 4 (60) | 1 (25) | 9 (47) |
| Diarrhoea | 1 (20) | 4 (40) | 1 (25) | 6 (32) |
| Vomiting | 2 (40) | 1 (10) | 1 (25) | 4 (21) |
| Upper respiratory tract infection* | 2 (40) | 3 (30) | 1 (25) | 6 (32) |
| Cough | 3 (60) | 2 (20) | 0 (0) | 5 (26) |
| Nasal congestion | 2 (40) | 2 (20) | 0 (0) | 4 (21) |
| Tachycardia | 2 (40) | 2 (20) | 0 (0) | 4 (21) |
*Includes the preferred terms upper respiratory tract infection and nasopharyngitis.
Source: US FDA.34
aHUS, atypical haemolytic uraemic syndrome; FDA, Food and Drug Administration.