Table 2. Percentage of common nonhematologic AEs (all grades and grade 3/4) and hematologic abnormalities (grade 3/4) at 8 months with dasatinib in patients intolerant/resistant to imatinib19, 20, 35.
Chronic-phase CML20 (n=186) | Accelerated-phase CML19(n=107) | Myeloid blast crisis35(n=74) | Lymphoid blast crisis35 (n=42) | |||||
---|---|---|---|---|---|---|---|---|
|
All gradesa |
Grade 3/4 |
All gradesa |
Grade 3/4 |
All gradesa |
Grade 3/4 |
All gradesa |
Grade 3/4 |
Nonhematologic | ||||||||
Abdominal pain | NR | NR | 11 | 0 | NR | NR | NR | NR |
Anorexia | NR | NR | 13 | 1 | 11 | 1 | 5 | 5 |
Arthralgia | NR | NR | 10 | 0 | 11 | 3 | 5 | 0 |
Asthenia | 20 | 2 | 19 | 4 | 15 | 3 | 10 | 2 |
Diarrhea | 30 | 2 | 50 | 6 | 36 | 8 | 31 | 0 |
Dizziness | NR | NR | 11 | 0 | NR | NR | NR | NR |
Dyspnea | 27 | 3 | 16 | 4 | 18 | 7 | 12 | 0 |
Epistaxis | NR | NR | 11 | 0 | 12 | 1 | 2 | 0 |
Fatigue | 28 | 1 | 23 | 4 | 12 | 1 | 29 | 5 |
Febrile neutropenia | NR | NR | NR | NR | 4 | 4 | 14 | 12 |
Gastrointestinal hemorrhage | NR | NR | 11 | 7 | 12 | 8 | 0 | 0 |
Headache | 34 | 1 | 28 | 1 | 8 | 0 | 14 | 2 |
Myalgia | NR | NR | 10 | 1 | NR | NR | NR | NR |
Nausea | 19 | 1 | 22 | 0 | 16 | 4 | 24 | 0 |
Pain in extremity | NR | NR | 14 | 0 | NR | NR | NR | NR |
Peripheral edema | 18 | 0 | 22 | 0 | 19 | 0 | 12 | 0 |
Pleural effusion | 19 | 3 | 23 | 3 | 28 | 14 | 14 | 2 |
Pyrexia | NR | NR | 23 | 4 | 16 | 5 | 19 | 2 |
Rash | 22 | <1 | 15 | 1 | 12 | 0 | 17 | 5 |
Vomiting | NR | NR | 11 | 0 | 16 | 1 | 10 | 2 |
Hematologic | ||||||||
Leukocytopenia | NR | 25 | NR | 61 | NR | 64 | NR | 69 |
Neutropenia | NR | 49 | NR | 82 | NR | 82 | NR | 79 |
Thrombocytopenia | NR | 47 | NR | 76 | NR | 84 | NR | 88 |
Anemia | NR | 22 | NR | 69 | NR | 68 | NR | 52 |
Abbreviations: AE, adverse event; CML, chronic myeloid leukemia; NR, not reported.
All-grade AEs reported when frequency was >10% for any AE.