Table 4.
Adverse Events on Dasatinib, Regardless of Causality, Present in at Least 5% of Patients or With at Least One Grade ≥ 3 Event
Adverse Event | All Patients (N = 62) |
Once-Daily Schedule |
Twice-Daily Schedule |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Any Grade |
Grade 3 or 4 |
Any Grade |
Grade 3 or 4 |
Any Grade |
Grade 3 or 4 |
|||||||
No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | |
Nonhematologic | ||||||||||||
Pain (joint, muscle) | 46 | 74 | 4 | 6 | 24 | 39 | 2 | 3 | 22 | 35 | 2 | 3 |
Fatigue | 45 | 73 | 4 | 6 | 22 | 35 | 4 | 6 | 23 | 37 | 0 | 0 |
Dyspnea | 28 | 45 | 3 | 5 | 12 | 19 | 2 | 3 | 16 | 26 | 1 | 2 |
Neuropathy | 19 | 31 | 3 | 5 | 10 | 16 | 1 | 2 | 9 | 15 | 2 | 3 |
Memory impairment | 12 | 19 | 3 | 5 | 9 | 15 | 2 | 3 | 3 | 5 | 1 | 2 |
Headache | 35 | 56 | 2 | 3 | 19 | 31 | 2 | 3 | 16 | 26 | 0 | 0 |
Cardiac | 13 | 21 | 2 | 3 | 3 | 5 | 2 | 3 | 10 | 16 | 0 | 0 |
Skin toxicity | 36 | 58 | 1 | 2 | 20 | 32 | 0 | 0 | 16 | 26 | 1 | 2 |
Diarrhea | 33 | 53 | 1 | 2 | 15 | 24 | 1 | 2 | 18 | 29 | 0 | 0 |
Ocular/vision | 20 | 32 | 1 | 2 | 13 | 21 | 1 | 2 | 7 | 11 | 0 | 0 |
Hyperglycemia | 15 | 24 | 1 | 2 | 9 | 15 | 1 | 2 | 6 | 10 | 0 | 0 |
Mood alteration | 15 | 24 | 1 | 2 | 11 | 18 | 0 | 0 | 5 | 8 | 1 | 2 |
Pleural effusion | 8 | 13 | 1 | 2 | 2 | 3 | 1 | 2 | 6 | 10 | 0 | 0 |
Pruritus | 5 | 8 | 1 | 2 | 3 | 5 | 0 | 0 | 2 | 3 | 1 | 2 |
Renal, genitourinary | 5 | 8 | 1 | 2 | 3 | 5 | 1 | 2 | 2 | 3 | 0 | 0 |
Weight gain | 4 | 6 | 1 | 2 | 1 | 2 | 0 | 0 | 3 | 5 | 1 | 2 |
Hypophosphatemia | 4 | 6 | 1 | 2 | 2 | 3 | 0 | 0 | 2 | 3 | 1 | 2 |
Hyponatremia | 3 | 5 | 1 | 2 | 1 | 2 | 0 | 0 | 2 | 3 | 1 | 2 |
Nausea | 28 | 45 | 0 | 0 | 12 | 19 | 0 | 0 | 16 | 26 | 0 | 0 |
GI | 23 | 37 | 0 | 0 | 10 | 16 | 0 | 0 | 13 | 21 | 0 | 0 |
Dizziness | 22 | 35 | 0 | 0 | 11 | 18 | 0 | 0 | 11 | 18 | 0 | 0 |
Edema | 20 | 32 | 0 | 0 | 11 | 18 | 0 | 0 | 9 | 15 | 0 | 0 |
Cough | 16 | 26 | 0 | 0 | 8 | 13 | 0 | 0 | 8 | 13 | 0 | 0 |
Vomiting | 13 | 21 | 0 | 0 | 7 | 11 | 0 | 0 | 6 | 10 | 0 | 0 |
Insomnia | 13 | 21 | 0 | 0 | 9 | 15 | 0 | 0 | 4 | 6 | 0 | 0 |
Elevated ALT | 10 | 16 | 0 | 0 | 4 | 6 | 0 | 0 | 6 | 10 | 0 | 0 |
Elevated AST | 9 | 15 | 0 | 0 | 6 | 10 | 0 | 0 | 3 | 5 | 0 | 0 |
Alopecia | 9 | 15 | 0 | 0 | 3 | 5 | 0 | 0 | 6 | 10 | 0 | 0 |
Allergy | 8 | 13 | 0 | 0 | 6 | 10 | 0 | 0 | 2 | 3 | 0 | 0 |
Chills/rigors | 7 | 11 | 0 | 0 | 3 | 5 | 0 | 0 | 4 | 6 | 0 | 0 |
Sweating | 7 | 11 | 0 | 0 | 4 | 6 | 0 | 0 | 3 | 5 | 0 | 0 |
Hemorrhage | 6 | 10 | 0 | 0 | 2 | 3 | 0 | 0 | 4 | 6 | 0 | 0 |
Hematologic | ||||||||||||
Neutropenia | 39 | 63 | 13 | 21 | 19 | 31 | 8 | 13 | 20 | 32 | 5 | 8 |
Anemia | 50 | 81 | 4 | 6 | 24 | 39 | 1 | 2 | 26 | 42 | 3 | 5 |
Thrombocytopenia | 43 | 69 | 6 | 10 | 20 | 32 | 2 | 3 | 23 | 37 | 4 | 6 |