Success rates in the primary analysis population
. | Deferasirox . | Deferoxamine . |
|---|---|---|
| All LIC values | ||
| No. patients | 276 | 277 |
| Success rate, no. (%) | 146 (52.9) | 184 (66.4) |
| 95% CI | 47.0, 58.8 | 60.9, 72.0 |
| LIC below 7 mg Fe/g dw | ||
| No. patients | 85 | 87 |
| Success rate, no. (%) | 34 (40.0) | 72 (82.8) |
| 95% CI | 29.6, 50.4 | 74.8, 90.7 |
| LIC at least 7 mg Fe/g dw | ||
| No. patients | 191 | 190 |
| Success rate, no. (%) | 112 (58.6) | 112 (58.9) |
| 95% CI | 51.7, 65.6 | 52.0, 65.9 |
. | Deferasirox . | Deferoxamine . |
|---|---|---|
| All LIC values | ||
| No. patients | 276 | 277 |
| Success rate, no. (%) | 146 (52.9) | 184 (66.4) |
| 95% CI | 47.0, 58.8 | 60.9, 72.0 |
| LIC below 7 mg Fe/g dw | ||
| No. patients | 85 | 87 |
| Success rate, no. (%) | 34 (40.0) | 72 (82.8) |
| 95% CI | 29.6, 50.4 | 74.8, 90.7 |
| LIC at least 7 mg Fe/g dw | ||
| No. patients | 191 | 190 |
| Success rate, no. (%) | 112 (58.6) | 112 (58.9) |
| 95% CI | 51.7, 65.6 | 52.0, 65.9 |
For all LIC values, the difference and 95% CI were -13.5 (-21.6, -5.4); for LIC values less than 7 mg Fe/g dw, they were -42.8 (-55.9, -29.7); and for LIC values of at least 7 mg Fe/g dw, they were -0.3 (-10.2, 9.6). The prespecified boundary for noninferiority in the entire population was met in population of patients with LIC of at least 7 mg Fe/g dw who received 20 and 30 mg/kg doses of deferasirox. If patients in this group with biopsy only are included, the success rate for deferasirox (n = 176) was 59.7% and that with deferoxamine (n = 179) was 58.7%. The difference and 95% CI were 1.0 (-9.2, 11.2).