Failure and reasons for treatment discontinuation
Variable . | IRIS study, no. (%) . | CML91 study, no. (%) . |
|---|---|---|
| No. assessable | 551 | 325 |
| No. crossovers | 14 | 0 |
| No. discontinuations | 130 (24) | 202 (62) |
| Unsatisfactory therapeutic effect | 46 (8) | 116 (36) |
| Adverse event(s) | 20 (4) | 51 (16) |
| Death | 8 (1) | 1 (1) |
| Toxicity and insufficient response | 0 | 32 (10) |
| No longer requires study drug | ||
| BMT | 16 (3) | 0 (0) |
| Complete response | NA | 2 (1) |
| Lost to follow-up | (4) (1) | 0 (0) |
| Other exit from protocol | 36 (7) | 0 (0) |
| BMT | 38 (7) | 33 (10) |
| Allogeneic | NA | 4 |
| Autograft | NA | 29 |
| Death | 47 (9) | 63 (19) |
| CML (acceleration and blast crisis) | 21 (45) | 45 (71) |
| BMT | 5 (11) | 10 (16) |
| Toxicity of treatment | 0 (0) | 1 (2) |
| Unrelated to CML disease or treatment | 20 (43) | 7 (11) |
| Unknown | 1 (2) | 0 (0) |
Variable . | IRIS study, no. (%) . | CML91 study, no. (%) . |
|---|---|---|
| No. assessable | 551 | 325 |
| No. crossovers | 14 | 0 |
| No. discontinuations | 130 (24) | 202 (62) |
| Unsatisfactory therapeutic effect | 46 (8) | 116 (36) |
| Adverse event(s) | 20 (4) | 51 (16) |
| Death | 8 (1) | 1 (1) |
| Toxicity and insufficient response | 0 | 32 (10) |
| No longer requires study drug | ||
| BMT | 16 (3) | 0 (0) |
| Complete response | NA | 2 (1) |
| Lost to follow-up | (4) (1) | 0 (0) |
| Other exit from protocol | 36 (7) | 0 (0) |
| BMT | 38 (7) | 33 (10) |
| Allogeneic | NA | 4 |
| Autograft | NA | 29 |
| Death | 47 (9) | 63 (19) |
| CML (acceleration and blast crisis) | 21 (45) | 45 (71) |
| BMT | 5 (11) | 10 (16) |
| Toxicity of treatment | 0 (0) | 1 (2) |
| Unrelated to CML disease or treatment | 20 (43) | 7 (11) |
| Unknown | 1 (2) | 0 (0) |
BMT indicates bone marrow transplantation; NA, not assessable