Demographics, disease history, and characteristics of patients at baseline
| Characteristics . | Patients with confirmed diagnosis . | All enrolled patients . | ||
|---|---|---|---|---|
| All doses n = 181 . | 400-mg dose group n = 62 . | 600-mg dose group n = 119 . | All doses n = 235 . | |
| Age (y) | ||||
| Median (range) | 57 (22-86) | 56 (25-86) | 58 (22-80) | 56 (22-86) |
| Sex, n (%) | ||||
| Male | 92 (51) | 34 (55) | 58 (49) | 118 (50) |
| Female | 89 (49) | 28 (45) | 61 (51) | 117 (50) |
| ECOG score, n (%) | ||||
| Grade 0-1 | 143 (79) | 46 (74) | 97 (82) | 180 (77) |
| Grade 2 | 30 (17) | 15 (24) | 15 (13) | 41 (17) |
| Grade 3 | 0 | 0 | 0 | 2 (1) |
| Splenomegaly, n (%) | ||||
| Any splenomegaly | 104 (57) | 39 (63) | 65 (55) | 127 (54) |
| At least 10 cm | 48 (27) | 21 (34) | 27 (23) | 62 (26) |
| Prior therapy for accelerated phase, n (%) | 119 (66) | 41 (66) | 78 (66) | 157 (67) |
| WBC (× 109/L) | ||||
| Median | 25 | 21 | 25 | 21 |
| Range | 1-330 | 1-184 | 1-330 | 1-330 |
| At least 20 × 109/L, n (%) | 102 (56) | 31 (50) | 71 (60) | 124 (53) |
| Blasts in peripheral blood (%) | ||||
| Median | 4 | 4 | 5 | 4 |
| Range | 0-29 | 0-29 | 0-27 | 0-71 |
| At least 15% blasts, n (%) | 36 (20) | 10 (16) | 26 (22) | 54 (23) |
| Blasts in bone marrow (%) | ||||
| Median | 15 | 16 | 15 | 15 |
| Range | 0-29 | 0-27 | 0-29 | 0-77 |
| At least 15% blasts, n (%) | 94 (52) | 33 (53) | 61 (51) | 118 (50) |
| Basophils in peripheral blood | ||||
| At least 20%, n (%) | 24 (13) | 8 (13) | 16 (13) | 24 (10) |
| Hemoglobin (g/L) | ||||
| Median | 101 | 104 | 99 | 103 |
| Range | 62-163 | 70-148 | 62-163 | 62-163 |
| Platelets (× 109/L) | ||||
| Median | 241 | 211 | 267 | 263 |
| Range | 6-3067 | 12-2130 | 6-3067 | 6-3067 |
| Less than 100 × 1009/L, n (%) | 63 (35) | 23 (37) | 40 (34) | 73 (31) |
| Characteristics . | Patients with confirmed diagnosis . | All enrolled patients . | ||
|---|---|---|---|---|
| All doses n = 181 . | 400-mg dose group n = 62 . | 600-mg dose group n = 119 . | All doses n = 235 . | |
| Age (y) | ||||
| Median (range) | 57 (22-86) | 56 (25-86) | 58 (22-80) | 56 (22-86) |
| Sex, n (%) | ||||
| Male | 92 (51) | 34 (55) | 58 (49) | 118 (50) |
| Female | 89 (49) | 28 (45) | 61 (51) | 117 (50) |
| ECOG score, n (%) | ||||
| Grade 0-1 | 143 (79) | 46 (74) | 97 (82) | 180 (77) |
| Grade 2 | 30 (17) | 15 (24) | 15 (13) | 41 (17) |
| Grade 3 | 0 | 0 | 0 | 2 (1) |
| Splenomegaly, n (%) | ||||
| Any splenomegaly | 104 (57) | 39 (63) | 65 (55) | 127 (54) |
| At least 10 cm | 48 (27) | 21 (34) | 27 (23) | 62 (26) |
| Prior therapy for accelerated phase, n (%) | 119 (66) | 41 (66) | 78 (66) | 157 (67) |
| WBC (× 109/L) | ||||
| Median | 25 | 21 | 25 | 21 |
| Range | 1-330 | 1-184 | 1-330 | 1-330 |
| At least 20 × 109/L, n (%) | 102 (56) | 31 (50) | 71 (60) | 124 (53) |
| Blasts in peripheral blood (%) | ||||
| Median | 4 | 4 | 5 | 4 |
| Range | 0-29 | 0-29 | 0-27 | 0-71 |
| At least 15% blasts, n (%) | 36 (20) | 10 (16) | 26 (22) | 54 (23) |
| Blasts in bone marrow (%) | ||||
| Median | 15 | 16 | 15 | 15 |
| Range | 0-29 | 0-27 | 0-29 | 0-77 |
| At least 15% blasts, n (%) | 94 (52) | 33 (53) | 61 (51) | 118 (50) |
| Basophils in peripheral blood | ||||
| At least 20%, n (%) | 24 (13) | 8 (13) | 16 (13) | 24 (10) |
| Hemoglobin (g/L) | ||||
| Median | 101 | 104 | 99 | 103 |
| Range | 62-163 | 70-148 | 62-163 | 62-163 |
| Platelets (× 109/L) | ||||
| Median | 241 | 211 | 267 | 263 |
| Range | 6-3067 | 12-2130 | 6-3067 | 6-3067 |
| Less than 100 × 1009/L, n (%) | 63 (35) | 23 (37) | 40 (34) | 73 (31) |