Treatment status and reasons for discontinuation
| Status . | Patients, n (%) . | |
|---|---|---|
| Dasatinib, 100 mg QD, N = 258 . | Imatinib, 400 mg QD, N = 258 . | |
| Received treatment | 258 (100) | 258 (100) |
| Still on treatment | 199 (77) | 194 (75) |
| Discontinued treatment | 59 (23) | 64 (25) |
| Progression* | 14 (5) | 17 (7) |
| Treatment failure† | 8 (3) | 11 (4) |
| Drug-related adverse event | 18 (7) | 12 (5) |
| Nonhematologic | 12 (5) | 8 (3) |
| Hematologic | 6 (2) | 4 (1) |
| Unrelated adverse event | 5 (2) | 1 (< 1) |
| Death‡ | 4 (2) | 1 (< 1) |
| Withdrew consent | 4 (2) | 3 (1) |
| Became pregnant | 2 (1) | 1 (< 1) |
| Did not adhere to therapy | 0 | 2 (1) |
| Lost to follow-up | 0 | 3 (1) |
| Requested to discontinue§ | 2 (1) | 3 (1) |
| Other reason | 2 (1) | 10 (4) |
| Status . | Patients, n (%) . | |
|---|---|---|
| Dasatinib, 100 mg QD, N = 258 . | Imatinib, 400 mg QD, N = 258 . | |
| Received treatment | 258 (100) | 258 (100) |
| Still on treatment | 199 (77) | 194 (75) |
| Discontinued treatment | 59 (23) | 64 (25) |
| Progression* | 14 (5) | 17 (7) |
| Treatment failure† | 8 (3) | 11 (4) |
| Drug-related adverse event | 18 (7) | 12 (5) |
| Nonhematologic | 12 (5) | 8 (3) |
| Hematologic | 6 (2) | 4 (1) |
| Unrelated adverse event | 5 (2) | 1 (< 1) |
| Death‡ | 4 (2) | 1 (< 1) |
| Withdrew consent | 4 (2) | 3 (1) |
| Became pregnant | 2 (1) | 1 (< 1) |
| Did not adhere to therapy | 0 | 2 (1) |
| Lost to follow-up | 0 | 3 (1) |
| Requested to discontinue§ | 2 (1) | 3 (1) |
| Other reason | 2 (1) | 10 (4) |
QD indicates once daily; and CHR, complete hematologic response.
Progression was defined per protocol as any of the following: doubling of white cell count to > 20 × 109/L in the absence of CHR, loss of CHR, increase in Philadelphia chromosome–positive BM metaphases to > 35%, transformation to accelerated/blast phase, or death from any cause.
Treatment failure was defined per protocol as no hematologic response by 3 months, no CHR or cytogenetic response by 6 months, no partial cytogenetic response by 12 months, or no complete cytogenetic response by 18 months.
Patients who discontinued due to death; total deaths and causes in patients on treatment or after discontinuation are shown in Table 6.
Patients who requested to discontinue but agreed to long-term follow-up.