Baseline demographic and disease characteristics in the ITT population
| Characteristics . | Nilotinib (n = 227) . | Dasatinib (n = 227) . | P value∗ . |
|---|---|---|---|
| Age, y | |||
| Median (range) | 53 (19-85) | 53 (17-90) | .70 |
| Sex, n (%) | |||
| Male | 142 (62.6) | 149 (65.6) | .56 |
| Female | 85 (37.4) | 78 (34.4) | |
| ECOG performance status, n (%) | |||
| 0 | 204 (89.9) | 199 (87.7) | .66 |
| 1 | 22 (9.70) | 26 (11.5) | |
| 2 | 1 (0.40) | 2 (0.90) | |
| Sokal risk group, n (%) | |||
| Low risk | 100 (44.1) | 101 (44.5) | 1.00 |
| Intermediate risk | 84 (37.0) | 84 (37.0) | |
| High risk | 43 (18.9) | 42 (18.5) | |
| EUTOS risk group, n (%) | |||
| Low risk | 196 (86.3) | 196 (86.3) | 1.00 |
| High risk | 31 (13.7) | 31 (13.7) | |
| Complications, n (%) | |||
| Yes | 67 (29.5) | 53 (23.3) | .17 |
| No | 158 (69.6) | 172 (75.8) | |
| Missing | 2 (0.90) | 2 (0.90) | |
| Medical history, n (%) | |||
| Yes | 73 (32.2) | 66 (29.1) | .67 |
| No | 147 (64.8) | 155 (68.3) | |
| Unknown | 3 (1.30) | 2 (0.90) | |
| Missing | 4 (1.80) | 4 (1.80) | |
| Additional chromosomal changes | |||
| Yes | 33 (14.5) | 29 (12.8) | .59 |
| No | 191 (84.1) | 196 (86.3) | |
| Missing | 3 (1.30) | 2 (0.90) | |
| Blood cell counts at diagnosis | |||
| WBC (per μL), median (range) | 35 230 (102.5-557 300) | 39 400 (49.8-586 500) | .38 |
| Hb (g/dL), median (range) | 12.9 (6.7-18.2) | 13.1 (6.6-19) | .67 |
| PLT (×104/μL), median (range) | 48 (10.2-282) | 48.1 (10.4-338) | .32 |
| Characteristics . | Nilotinib (n = 227) . | Dasatinib (n = 227) . | P value∗ . |
|---|---|---|---|
| Age, y | |||
| Median (range) | 53 (19-85) | 53 (17-90) | .70 |
| Sex, n (%) | |||
| Male | 142 (62.6) | 149 (65.6) | .56 |
| Female | 85 (37.4) | 78 (34.4) | |
| ECOG performance status, n (%) | |||
| 0 | 204 (89.9) | 199 (87.7) | .66 |
| 1 | 22 (9.70) | 26 (11.5) | |
| 2 | 1 (0.40) | 2 (0.90) | |
| Sokal risk group, n (%) | |||
| Low risk | 100 (44.1) | 101 (44.5) | 1.00 |
| Intermediate risk | 84 (37.0) | 84 (37.0) | |
| High risk | 43 (18.9) | 42 (18.5) | |
| EUTOS risk group, n (%) | |||
| Low risk | 196 (86.3) | 196 (86.3) | 1.00 |
| High risk | 31 (13.7) | 31 (13.7) | |
| Complications, n (%) | |||
| Yes | 67 (29.5) | 53 (23.3) | .17 |
| No | 158 (69.6) | 172 (75.8) | |
| Missing | 2 (0.90) | 2 (0.90) | |
| Medical history, n (%) | |||
| Yes | 73 (32.2) | 66 (29.1) | .67 |
| No | 147 (64.8) | 155 (68.3) | |
| Unknown | 3 (1.30) | 2 (0.90) | |
| Missing | 4 (1.80) | 4 (1.80) | |
| Additional chromosomal changes | |||
| Yes | 33 (14.5) | 29 (12.8) | .59 |
| No | 191 (84.1) | 196 (86.3) | |
| Missing | 3 (1.30) | 2 (0.90) | |
| Blood cell counts at diagnosis | |||
| WBC (per μL), median (range) | 35 230 (102.5-557 300) | 39 400 (49.8-586 500) | .38 |
| Hb (g/dL), median (range) | 12.9 (6.7-18.2) | 13.1 (6.6-19) | .67 |
| PLT (×104/μL), median (range) | 48 (10.2-282) | 48.1 (10.4-338) | .32 |
ECOG, Eastern Cooperative Oncology Group; Hb, hemoglobin; PLT, platelet; WBC, white blood cell.
Fisher exact test