Baseline patient characteristics
| . | Nilotinib, n = 134 . | Imatinib, n = 133 . |
|---|---|---|
| Median age (range), y | 41 (18-76) | 39 (19-74) |
| Median time since diagnosis (range), d | 39.5 (7-177) | 38.0 (5-194)* |
| Sex | ||
| Male | 91 (67.9) | 81 (60.9) |
| Female | 43 (32.1) | 52 (39.1) |
| Atypical transcripts | 1 (0.7) | 1 (0.8) |
| Sokal risk group† | ||
| Low | 69 (51.5) | 69 (51.9) |
| Intermediate | 44 (32.8) | 43 (32.3) |
| High | 21 (15.7) | 21 (15.8) |
| Prior rIFNɑ therapy | ||
| Yes | 11 (8.2) | 11 (8.3) |
| No | 123 (91.8) | 122 (91.7) |
| Other prior therapy | ||
| Hydroxyurea | 129 (96.3) | 126 (94.7) |
| Imatinib‡ | 6 (4.5) | 7 (5.3) |
| Cardiovascular risk factors at baseline§ | ||
| Hypertension | 9 (6.8) | 10 (7.6) |
| Hyperlipidemia | 1 (0.8) | 2 (1.5) |
| Diabetes mellitus | 4 (3.0) | 5 (3.8) |
| Prior cardiovascular event | 3 (2.3) | 0 |
| . | Nilotinib, n = 134 . | Imatinib, n = 133 . |
|---|---|---|
| Median age (range), y | 41 (18-76) | 39 (19-74) |
| Median time since diagnosis (range), d | 39.5 (7-177) | 38.0 (5-194)* |
| Sex | ||
| Male | 91 (67.9) | 81 (60.9) |
| Female | 43 (32.1) | 52 (39.1) |
| Atypical transcripts | 1 (0.7) | 1 (0.8) |
| Sokal risk group† | ||
| Low | 69 (51.5) | 69 (51.9) |
| Intermediate | 44 (32.8) | 43 (32.3) |
| High | 21 (15.7) | 21 (15.8) |
| Prior rIFNɑ therapy | ||
| Yes | 11 (8.2) | 11 (8.3) |
| No | 123 (91.8) | 122 (91.7) |
| Other prior therapy | ||
| Hydroxyurea | 129 (96.3) | 126 (94.7) |
| Imatinib‡ | 6 (4.5) | 7 (5.3) |
| Cardiovascular risk factors at baseline§ | ||
| Hypertension | 9 (6.8) | 10 (7.6) |
| Hyperlipidemia | 1 (0.8) | 2 (1.5) |
| Diabetes mellitus | 4 (3.0) | 5 (3.8) |
| Prior cardiovascular event | 3 (2.3) | 0 |
Values are n (%) unless otherwise indicated.
Two patients in the imatinib arm were enrolled >6 months after initial diagnosis.
Sokal risk scores calculated per evaluations performed at diagnosis (prior to receipt of any CML treatment).
No patient was previously treated with imatinib for >2 weeks.
In the safety population (nilotinib, n = 133; imatinib, n = 132).