Most common (≥ 3 patients in total) investigator-assessed drug-related AEs
| AE, n (%) . | Deferasirox 5 mg/kg/d (n = 55) . | Placebo 5 mg/kg/d (n = 28) . | Deferasirox 10 mg/kg/d (n = 55) . | Placebo 10 mg/kg/d (n = 28) . | Total (n = 166) . |
|---|---|---|---|---|---|
| Nausea | 3 (5.5) | 1 (3.6) | 4 (7.3) | 3 (10.7) | 11 (6.6) |
| Skin rash | 2 (3.6) | 0 | 5 (9.1) | 1 (3.6) | 8 (4.8) |
| Diarrhea | 0 | 0 | 5 (9.1) | 1 (3.6) | 6 (3.6) |
| Headache | 2 (3.6) | 0 | 1 (1.8) | 2 (7.1) | 5 (3.0) |
| Upper abdominal pain | 2 (3.6) | 0 | 1 (1.8) | 0 | 3 (1.8) |
| Abdominal pain | 1 (1.8) | 1 (3.6) | 1 (1.8) | 0 | 3 (1.8) |
| AE, n (%) . | Deferasirox 5 mg/kg/d (n = 55) . | Placebo 5 mg/kg/d (n = 28) . | Deferasirox 10 mg/kg/d (n = 55) . | Placebo 10 mg/kg/d (n = 28) . | Total (n = 166) . |
|---|---|---|---|---|---|
| Nausea | 3 (5.5) | 1 (3.6) | 4 (7.3) | 3 (10.7) | 11 (6.6) |
| Skin rash | 2 (3.6) | 0 | 5 (9.1) | 1 (3.6) | 8 (4.8) |
| Diarrhea | 0 | 0 | 5 (9.1) | 1 (3.6) | 6 (3.6) |
| Headache | 2 (3.6) | 0 | 1 (1.8) | 2 (7.1) | 5 (3.0) |
| Upper abdominal pain | 2 (3.6) | 0 | 1 (1.8) | 0 | 3 (1.8) |
| Abdominal pain | 1 (1.8) | 1 (3.6) | 1 (1.8) | 0 | 3 (1.8) |