Summary of AEs regardless of relationship to study drug in patients treated with DFX-DFO in combination followed by DFX monotherapy over 24 months
| AE . | All patients, n = 60, 24 mo, n (%) . |
|---|---|
| Patients with any AE(s) | 54 (90.0) |
| Discontinued as a result of AEs | 5 (8.3) |
| Abdominal pain | 2 (3.3) |
| Arthritis | 1 (1.7) |
| DRESS* | 1 (1.7) |
| Pruritus | 1 (1.7) |
| AEs leading to dose adjustment or interruption (≥5% of patients) | 29 (48.3) |
| UPCR increase | 6 (10.0) |
| Abdominal pain | 5 (8.3) |
| Diarrhea | 5 (8.3) |
| Pyrexia | 4 (6.7) |
| Nausea | 3 (5.0) |
| Influenza | 3 (5.0) |
| Blood creatinine increase | 3 (5.0) |
| AE . | All patients, n = 60, 24 mo, n (%) . |
|---|---|
| Patients with any AE(s) | 54 (90.0) |
| Discontinued as a result of AEs | 5 (8.3) |
| Abdominal pain | 2 (3.3) |
| Arthritis | 1 (1.7) |
| DRESS* | 1 (1.7) |
| Pruritus | 1 (1.7) |
| AEs leading to dose adjustment or interruption (≥5% of patients) | 29 (48.3) |
| UPCR increase | 6 (10.0) |
| Abdominal pain | 5 (8.3) |
| Diarrhea | 5 (8.3) |
| Pyrexia | 4 (6.7) |
| Nausea | 3 (5.0) |
| Influenza | 3 (5.0) |
| Blood creatinine increase | 3 (5.0) |
AE, adverse event; DFO, deferoxamine; DFX, deferasirox; DRESS, drug rash with eosinophilia and systemic symptoms; UPCR, urinary protein/creatinine ratio.
Suspected by the investigator. This case has been further evaluated by independent experts with no consensus for the diagnosis of DRESS syndrome.