Table 1.
Treatment-Emergent AEs and On-Treatment Laboratory Abnormalities
| Toxicity, n (%) | Bosutinib (n=248) |
Imatinib (n=251) |
||
|---|---|---|---|---|
| All Grades | Grade 3/4 | All Grades | Grade 3/4 | |
| Treatment-emergent AEs reported for ≥10% (all grades) of patients | ||||
| Hematologic | ||||
| Thrombocytopenia | 69 (28) | 31 (13) | 70 (28) | 34 (14) |
| Neutropenia | 33 (13) | 20 (8) | 75 (30) | 41 (16) |
| Anemia | 61 (25) | 21 (9) | 58 (23) | 14 (6) |
| Leukopenia | 23 (9) | 6 (2) | 54 (22) | 14 (6) |
| Nonhematologic | ||||
| Diarrhea | 173 (70) | 29 (12) | 65 (26) | 2 (1) |
| Vomiting | 82 (33) | 8 (3) | 41 (16) | 1 (<1) |
| Increased ALT | 81 (33) | 46 (19) | 23 (9) | 8 (3) |
| Nausea | 80 (32) | 2 (1) | 91 (36) | 1 (<1) |
| Increased AST | 69 (28) | 20 (8) | 24 (10) | 8 (3) |
| Rash | 61 (25) | 4 (2) | 49 (20) | 2 (1) |
| Pyrexia | 46 (19) | 3 (1) | 30 (12) | 3 (1) |
| Increased lipase | 36 (15) | 21 (9) | 28 (11) | 15 (6) |
| Upper abdominal pain | 36 (15) | 0 | 19 (8) | 0 |
| Abdominal pain | 34 (14) | 3 (1) | 19 (8) | 1 (<1) |
| Fatigue | 32 (13) | 3 (1) | 34 (14) | 2 (1) |
| Headache | 32 (13) | 1 (<1) | 30 (12) | 0 |
| Upper respiratory tract infection | 30 (12) | 0 | 21 (8) | 0 |
| Cough | 23 (9) | 0 | 27 (11) | 0 |
| Hypophosphatemia | 20 (8) | 3 (1) | 49 (20) | 25 (10) |
| Increased creatine phosphokinase | 20 (8) | 2 (1) | 51 (20) | 12 (5) |
| Arthralgia | 19 (8) | 0 | 32 (13) | 1 (<1) |
| Myalgia | 13 (5) | 0 | 30 (12) | 2 (1) |
| Muscle cramps | 12 (5) | 0 | 56 (22) | 0 |
| Peripheral edema | 12 (5) | 0 | 30 (12) | 0 |
| Bone pain | 9 (4) | 0 | 27 (11) | 2 (1) |
| Periorbital edema | 4 (2) | 0 | 36 (14) | 0 |
| Laboratory abnormalities reported for ≥30% (all grades) of patients | ||||
| Hematologic | ||||
| Anemia | 207 (84) | 20 (8) | 223 (89) | 19 (8) |
| Thrombocytopenia | 165 (67) | 34 (14) | 160 (64) | 37 (15) |
| Leukopenia | 115 (46) | 10 (4) | 179 (71) | 24 (10) |
| Neutropenia | 103 (42) | 25 (10) | 156 (62) | 54 (22) |
| Lymphopenia | 90 (36) | 0 | 103 (41) | 0 |
| Nonhematologic | ||||
| Increased ALT | 173 (70) | 57 (23) | 94 (38) | 11 (4) |
| Increased AST | 148 (60) | 29 (12) | 94 (38) | 11 (4) |
| Hypophosphatemia | 124 (50) | 17 (7) | 172 (69) | 55 (22) |
| Hypocalcemia | 119 (48) | 11 (4) | 138 (55) | 6 (2) |
| Increased lipase | 113 (46) | 29 (12) | 97 (39) | 16 (6) |
| Increased alkaline phosphatase | 112 (45) | 1 (<1) | 98 (39) | 1 (<1) |
| Hyperglycemia | 93 (38) | 6 (2) | 99 (39) | 4 (2) |
| Decreased bicarbonate | 88 (36) | 1 (<1) | 82 (33) | 1 (<1) |
| Increased creatine kinase | 83 (34) | 1 (<1) | 186 (74) | 17 (7) |
| Hypokalemia | 45 (18) | 4 (2) | 92 (37) | 15 (6) |
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.