Tolerability and safety parameters, stratified by dose
. | . | Initial deferasirox dose, mg/kg/d . | . | . | . | |||
|---|---|---|---|---|---|---|---|---|
. | Total . | 5 . | 10 . | 20 . | 30 . | |||
| Total no. of patients | 296 | 15 | 78 | 84 | 119 | |||
| Mean dose ± SD, mg/kg/d | 19.9 ± 8.3 | 6.2 ± 1.6 | 10.2 ± 1.2 | 19.4 ± 1.7 | 28.2 ± 3.5 | |||
| Dose adjustments, no. of patients (%) | 109 (36.8) | 8 (53.3) | 24 (30.8) | 28 (33.3) | 49 (41.2) | |||
| Discontinuations, no. of patients (%) | 17 (5.7) | 0 (0) | 8 (10.3) | 3 (3.6) | 6 (5.0) | |||
| GI events, no. of patients (%)* | 45 (15.2) | 1 (6.7) | 9 (11.5) | 12 (14.3) | 23 (19.3) | |||
| Skin rash, no. of patients (%)† | 32 (10.8) | 0 (0) | 8 (10.3) | 7 (8.3) | 17 (14.3) | |||
| Nonprogressive creatinine increases, no. of patients (%)† | 113 (38.3) | 1 (6.7) | 15 (19.2) | 33 (39.3) | 64 (53.8) | |||
| Increases above ULN, no. of patients (%) | 7 (2.4) | 0 (0) | 0 (0) | 3 (3.6) | 4 (3.4) | |||
. | . | Initial deferasirox dose, mg/kg/d . | . | . | . | |||
|---|---|---|---|---|---|---|---|---|
. | Total . | 5 . | 10 . | 20 . | 30 . | |||
| Total no. of patients | 296 | 15 | 78 | 84 | 119 | |||
| Mean dose ± SD, mg/kg/d | 19.9 ± 8.3 | 6.2 ± 1.6 | 10.2 ± 1.2 | 19.4 ± 1.7 | 28.2 ± 3.5 | |||
| Dose adjustments, no. of patients (%) | 109 (36.8) | 8 (53.3) | 24 (30.8) | 28 (33.3) | 49 (41.2) | |||
| Discontinuations, no. of patients (%) | 17 (5.7) | 0 (0) | 8 (10.3) | 3 (3.6) | 6 (5.0) | |||
| GI events, no. of patients (%)* | 45 (15.2) | 1 (6.7) | 9 (11.5) | 12 (14.3) | 23 (19.3) | |||
| Skin rash, no. of patients (%)† | 32 (10.8) | 0 (0) | 8 (10.3) | 7 (8.3) | 17 (14.3) | |||
| Nonprogressive creatinine increases, no. of patients (%)† | 113 (38.3) | 1 (6.7) | 15 (19.2) | 33 (39.3) | 64 (53.8) | |||
| Increases above ULN, no. of patients (%) | 7 (2.4) | 0 (0) | 0 (0) | 3 (3.6) | 4 (3.4) | |||