Summary of occurrence of events of severe IDIN in patients treated with deferiprone
| . | Severe IDIN . | |||||
|---|---|---|---|---|---|---|
| ANC thresholds, ×109/L . | ANC groups, ×109/L . | |||||
| <0.5 . | <0.2 . | <0.1 . | Group 1, 0.2-0.5 . | Group 2, 0.1-0.199 . | Group 3, <0.1 . | |
| Cumulative deferiprone exposure in clinical trials∗ = 1990.26 patient-y | ||||||
| Events, n (rate/100 patient-y) | 22 (1.11) | 13 (0.65) | 10 (0.50) | 9 (0.45) | 3† (0.15) | 10† (0.50) |
| Cumulative deferiprone exposure in the postmarketing setting = 111 570.24 patient-y | ||||||
| Events‡, n (rate/100 patient-y) | 176 (0.16) | 111 (0.10) | 91 (0.08) | 65 (0.06) | 20 (0.02) | 91 (0.08) |
| . | Severe IDIN . | |||||
|---|---|---|---|---|---|---|
| ANC thresholds, ×109/L . | ANC groups, ×109/L . | |||||
| <0.5 . | <0.2 . | <0.1 . | Group 1, 0.2-0.5 . | Group 2, 0.1-0.199 . | Group 3, <0.1 . | |
| Cumulative deferiprone exposure in clinical trials∗ = 1990.26 patient-y | ||||||
| Events, n (rate/100 patient-y) | 22 (1.11) | 13 (0.65) | 10 (0.50) | 9 (0.45) | 3† (0.15) | 10† (0.50) |
| Cumulative deferiprone exposure in the postmarketing setting = 111 570.24 patient-y | ||||||
| Events‡, n (rate/100 patient-y) | 176 (0.16) | 111 (0.10) | 91 (0.08) | 65 (0.06) | 20 (0.02) | 91 (0.08) |
ADR, adverse drug reaction.
Total of 977 patients with systemic iron overload were treated with deferiprone in clinical trials.
One patient had 2 events of severe IDIN, the event with ANC 0.18 × 109/L was counted in group 2, and the event with ANC 0 × 109/L was counted in group 3.
Events of severe IDIN in the postmarketing setting are defined as adverse drug reactions coded to agranulocytosis that had at least 1 ANC value.