Table 2.
Patient Disposition and Discontinuation Reasons
| Variable | Patients by Imatinib Dose |
|||
|---|---|---|---|---|
| 400 mg (n = 157) |
800 mg (n = 319) |
|||
| No. | % | No. | % | |
| Treatment disposition | ||||
| Continued initial treatment | 132 | 84.1 | 256 | 80.3 |
| Discontinued initial treatment | 25 | 15.9 | 63 | 19.7 |
| Reason for discontinuation | ||||
| Adverse events | 6 | 3.8 | 30 | 9.4 |
| Abnormal laboratory value(s) | 1 | 0.6 | 2 | 0.6 |
| Unsatisfactory therapeutic effect | 10 | 6.4 | 20 | 6.3 |
| Patient withdrew consent | 2 | 1.3 | 4 | 1.3 |
| Protocol violation | 3 | 1.9 | 1 | 0.3 |
| Administrative problems | 2 | 1.3 | 2 | 0.6 |
| No longer required study drug | 1 | 0.6 | 1 | 0.3 |
| Lost to follow-up | 0 | 2 | 0.6 | |
| Death | 0 | 1 | 0.3 | |
| Most frequent adverse events leading to discontinuation* | ||||
| Rash | 1 | 0.6 | 5 | 1.6 |
| Neutropenia | 1 | 0.6 | 4 | 1.3 |
| Nausea | 1 | 0.6 | 3 | 0.9 |
| Dyspnea | 0 | 3 | 0.9 | |
| Thrombocytopenia | 2 | 1.3 | 1 | 0.3 |
NOTE. Disposition in the intent-to-treat population as of December 31, 2007 (ie, data cutoff).
Safety population.