TABLE 3.
Nonhematologic Adverse Events (≥5%)a
| CIA N = 106 |
FIA N = 76 |
|||
|---|---|---|---|---|
| Nonhematologic Adverse Event | All Grades No. (%) |
Grade ≥3 No. (%) |
All Grades No. (%) |
Grade ≥3 No. (%) |
| Anorexia | 14 (13) | 3 (3) | 4 (5) | 1 (1) |
| Diarrhea | 18 (17) | 1 (1) | 9 (12) | 0 |
| Elevated ALT/AST | 31 (29) | 14 (13) | 3 (4) | 3 (4) |
| Elevated bilirubin | 28 (26) | 4 (4) | 7 (9) | 2 (3) |
| Fatigue | 17 (16) | 0 | 5 (7) | 1 (1) |
| Febrile neutropenia | 74 (70) | 74 (70) | 49 (64) | 49 (64) |
| Hemorrhage | 8 (8) | 3 (3) | 10 (13) | 3 (4) |
| Infection | 33 (31) | 32 (30) | 24 (32) | 22 (29) |
| Mucositis/stomatitis | 13 (12) | 1 (1) | 5 (7) | 2 (3) |
| Nausea/vomiting | 26 (25) | 2 (2) | 14 (18) | 2 (3) |
| Pain | 30 (28) | 10 (9) | 12 (16) | 4 (5) |
| Rash | 31 (29) | 4 (4) | 9 (12) | 2 (3) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CIA, clofarabine, idarubicin, and cytarabine; FIA, fludarabine, idarubicin, and cytarabine.
a
Adverse events were graded according to European LeukemiaNet (ELN) criteria.