Table 5.
Any grade | Grade ≥ 3 | |||||
---|---|---|---|---|---|---|
Dasatinib (N = 87) | Nilotinib (N = 87) | P value | Dasatinib (N = 87) | Nilotinib (N = 87) | P value | |
Hematological abnormality | ||||||
Neutropenia | 7(8) | 8(9) | 0.5 | 4(5) | 3(3) | 0.5 |
Anemia | 32(37) | 7(8) | <0.001 | 1(1) | 0(0) | 0.5 |
Thrombocytopenia | 17(20) | 5(6) | 0.006 | 7(8) | 4(5) | 0.27 |
Biochemical abnormality | ||||||
Elevated Bilirubin | 3(3) | 59(68) | <0.001 | 0(0) | 7(8) | 0.007 |
Elevated ALT | 10(12) | 47(54) | <0.001 | 0(0) | 1(1) | 0.5 |
Elevated AST | 15(17) | 38(44) | <0.001 | 0(0) | 1(1) | 0.5 |
Elevated ALP | 1(1) | 3(3) | 0.31 | 0(0) | 0(0) | NA |
Hyperglycemia | 1(1) | 8(9) | 0.017 | 0(0) | 1(1) | 0.5 |
Non-hematological AE | ||||||
Fatigue | 63(72) | 38(44) | <0.001 | 11(13) | 1(1) | 0.002 |
Weight loss | 2(2) | 1(1) | 0.5 | 0(0) | 0(0) | NA |
Anorexia | 3(3) | 3(3) | 0.66 | 0(0) | 0(0) | NA |
Flu like | 4(5) | 1(1) | 0.18 | 0(0) | 0(0) | NA |
Headache | 42(48) | 18(21) | <0.001 | 4(5) | 0(0) | 0.06 |
Mucositis | 6(7) | 2(2) | 0.14 | 0(0) | 0(0) | NA |
Palpitations | 8(9) | 4(5) | 0.19 | 0(0) | 0(0) | NA |
Prolonged QTc | 1(1) | 2(2) | 0.5 | 1(1) | 0(0) | 0.5 |
Cough | 17(20) | 1(1) | <0.001 | 0(0) | 0(0) | NA |
Dyspnea | 49(56) | 5(6) | <0.001 | 8(9) | 0(0) | 0.003 |
Nausea | 42(48) | 20(23) | <0.001 | 1(1) | 1(1) | 0.751 |
Vomiting | 24(28) | 6(7) | <0.001 | 0(0) | 0(0) | NA |
Diarrhea | 51(59) | 8(9) | <0.001 | 4(5) | 0(0) | 0.06 |
Constipation | 28(32) | 8(9) | <0.001 | 0(0) | 0(0) | NA |
Pruritus | 8(9) | 22(25) | 0.005 | 0(0) | 0(0) | NA |
Acne | 12(14) | 2(2) | 0.005 | 0(0) | 0(0) | NA |
Erythema Multiforme | 4(5) | 1(1) | 0.18 | 0(0) | 0(0) | NA |
Dizziness | 38(44) | 4(5) | <0.001 | 2(2) | 0(0) | 0.25 |
Sensory neuropathy | 37(43) | 2(2) | <0.001 | 3(3) | 0(0) | 0.12 |
Memory impairment | 39(45) | 2(2) | <0.001 | 5(6) | 0(0) | 0.029 |
Edema | 37(43) | 1(1) | <0.001 | 0(0) | 0(0) | NA |
Myalgia | 39(45) | 8(9) | <0.001 | 7(8) | 0(0) | 0.007 |
Pleural effusion | 18(21) | 0(0) | <0.001 | 0(0) | 0(0) | NA |
Cardiovascular event | 0(0) | 2(2) | 0.25 | 0(0) | 1(1) | 0.5 |