Table 3.
Treatment-related adverse events (≥ 10%, all grade)
| Total | Chronic phase CML | Accelerated phase CML | ||||
|---|---|---|---|---|---|---|
| Patient number | 165 | 127 | 38 | |||
| Event, n (%) | Any grades | G 3/4 | Any grades | G 3/4 | Any grades | G 3/4 |
| Treatment-related adverse events | 165 (100.0) | 131 (79.4) | 127 (100.0) | 97 (76.4) | 38 (100.0) | 34 (89.5) |
| Nonhematologic | 165 (100.0) | 81 (49.1) | 127 (100.0) | 61 (48.0) | 38 (100.0) | 20 (52.6) |
| Skin pigmentation | 139 (84.2) | 0 | 108 (85.0) | 0 | 31 (81.6) | 0 |
| Hypertriglyceridemia | 95 (57.6) | 12 (7.3) | 72 (56.7) | 11 (8.7) | 23 (60.5) | 1 (2.6) |
| Proteinuria | 84 (50.9) | 6 (3.6) | 65 (51.2) | 5 (3.9) | 19 (50.0) | 1 (2.6) |
| Hyperbilirubinemia | 69 (41.8) | 4 (2.4) | 56 (44.1) | 3 (2.4) | 13 (34.2) | 1 (2.6) |
| Hypocalcemia | 64 (38.8) | 0 | 45 (35.4) | 0 | 19 (50.0) | 0 |
| Increased alanine aminotransferase | 59 (35.8) | 4 (2.4) | 50 (39.4) | 3 (2.4) | 9 (23.7) | 1 (2.6) |
| Increased aspartate aminotransferase | 59 (35.8) | 4 (2.4) | 49 (38.6) | 2 (1.6) | 10 (26.3) | 2 (5.3) |
| Increased creatine phosphokinase | 48 (29.1) | 11 (6.7) | 43 (33.9) | 10 (7.9) | 5 (13.2) | 1 (2.6) |
| Increased γ-glutamyl transferase | 47 (28.5) | 5 (3.0) | 38 (29.9) | 5 (3.9) | 9 (23.7) | 0 |
| Hyperglycemia | 43 (26.1) | 1 (0.6) | 33 (26.0) | 1 (0.8) | 10 (26.3) | 0 |
| Hypokalemia | 42 (25.5) | 2 (1.2) | 32 (25.2) | 1 (0.8) | 10 (26.3) | 1 (2.6) |
| Hyponatremia | 38 (23.0) | 1 (0.6) | 28 (22.0) | 1 (0.8) | 10 (26.3) | 0 |
| Myalgia | 31 (18.8) | 0 | 23 (18.1) | 0 | 8 (21.1) | 0 |
| Pyrexia | 30 (18.2) | 9 (5.5) | 21 (16.5) | 5 (3.9) | 9 (23.7) | 4 (10.5) |
| Sinus tachycardia | 30 (18.2) | 0 | 23 (18.1) | 0 | 7 (18.4) | 0 |
| Rash | 27 (16.4) | 1 (0.6) | 19 (15.0) | 1 (0.8) | 8 (21.1) | 0 |
| Hypoalbuminemia | 26 (15.8) | 0 | 20 (15.7) | 0 | 6 (15.8) | 0 |
| Hyperphosphatemia | 22 (13.3) | 0 | 11 (8.7) | 0 | 11 (28.9) | 0 |
| Hypertension | 22 (13.3) | 9 (5.5) | 19 (15.0) | 7 (5.5) | 3 (7.9) | 2 (5.3) |
| Increased lipase | 22 (13.3) | 5 (3.0) | 16 (12.6) | 5 (3.9) | 6 (15.8) | 0 |
| Increased alkaline phosphatase | 21 (12.7) | 1 (0.6) | 16 (12.6) | 1 (0.8) | 5 (13.2) | 0 |
| Pain in extremity | 21 (12.7) | 2 (1.2) | 14 (11.0) | 1 (0.8) | 7 (18.4) | 1 (2.6) |
| Arthralgia | 19 (11.5) | 1 (0.6) | 11 (8.7) | 0 | 8 (21.1) | 1 (2.6) |
| Asthenia | 18 (10.9) | 0 | 12 (9.4) | 0 | 6 (15.8) | 0 |
| Hematologic | 138 (83.6) | 93 (56.4) | 102 (80.3) | 67 (52.8) | 36 (94.7) | 26 (68.4) |
| Thrombocytopenia | 126 (76.4) | 85 (51.5) | 93 (73.2) | 62 (48.8) | 33 (86.8) | 23 (60.5) |
| Anemia | 90 (54.5) | 38 (23.0) | 66 (52.0) | 26 (20.5) | 24 (63.2) | 12 (31.6) |
| Leukopenia | 56 (33.9) | 34 (20.6) | 37 (29.1) | 21 (16.5) | 19 (50.0) | 13 (34.2) |
| Neutropenia | 26 (15.8) | 19 (11.5) | 18 (14.2) | 11 (8.7) | 8 (21.1) | 8 (21.1) |