Table 1.
Baseline Demographic and Clinical Characteristics
| Characteristic | Patients by Imatinib Dose |
|||||
|---|---|---|---|---|---|---|
| 400 mg (n = 157) |
800 mg (n = 319) |
All (N = 476) |
||||
| No. | % | No. | % | No. | % | |
| Age, years | ||||||
| Median | 45 | 48 | 47 | |||
| Range | 18-75 | 18-75 | 18-75 | |||
| Male sex | 84 | 53.5 | 183 | 57.4 | 267 | 56.1 |
| ECOG performance status | ||||||
| 0 | 124 | 79.0 | 244 | 76.5 | 368 | 77.3 |
| 1 | 28 | 17.8 | 64 | 20.1 | 92 | 19.3 |
| 2 | 2 | 1.3 | 5 | 1.6 | 7 | 1.5 |
| Ethnicity | ||||||
| Asian | 22 | 14.0 | 42 | 13.2 | 64 | 13.4 |
| Black | 12 | 7.6 | 17 | 5.3 | 29 | 6.1 |
| White | 109 | 69.4 | 241 | 75.5 | 350 | 73.5 |
| Other | 14 | 8.9 | 19 | 6.0 | 33 | 6.9 |
| Time since diagnosis, days | ||||||
| Median | 28 | 28 | 28 | |||
| Range | −6 to 193* | 1 to 217 | −6 to 217* | |||
| Sokal risk group | ||||||
| Low | 62 | 39.5 | 135 | 42.3 | 197 | 41.4 |
| Intermediate | 53 | 33.8 | 111 | 34.8 | 164 | 34.5 |
| High | 42 | 26.8 | 73 | 22.9 | 115 | 24.2 |
| Prior treatment | ||||||
| Hydroxyurea | 109 | 69.4 | 227 | 71.2 | 336 | 70.6 |
| Anagrelide | 1 | 0.6 | 5 | 1.6 | 6 | 1.3 |
| Imatinib | 3 | 1.9 | 13 | 4.1 | 16 | 3.4 |
Abbreviation: ECOG, Eastern Cooperative Oncology Group.
*
One patient was enrolled on the basis of first results received, and final cytogenetic confirmation was 6 days after random assignment.