Table 2.
Most frequently reported AEs (in 20% of patients or more) by preferred term occurring in arm A or arm B
| AE | Arm A CPX-351 plus venetoclax (N = 27) |
Arm B CPX-351 plus midostaurin (N = 23) |
|---|---|---|
| Patients with any AE (all grades), n (%) | 27 (100) | 23 (100) |
| Patients with any hematologic AE (all grades), n (%) | ||
| Febrile neutropenia | 18 (67) | 18 (78) |
| Thrombocytopenia | 12 (44) | 16 (70) |
| Leukopenia | 11 (41) | 14 (61) |
| Neutropenia | 10 (37) | 9 (39) |
| Anemia | 7 (26) | 8 (35) |
| Patients with any nonhematologic AE (all grades), n (%) | ||
| Constipation | 14 (52) | 4 (17) |
| Nausea | 10 (37) | 15 (65) |
| Fatigue | 10 (37) | 6 (26) |
| Hypokalemia | 9 (33) | 8 (35) |
| Peripheral edema | 9 (33) | 7 (30) |
| Diarrhea | 8 (30) | 8 (35) |
| Maculopapular rash | 8 (30) | 5 (22) |
| Headache | 7 (26) | 10 (43) |
| Pyrexia | 7 (26) | 5 (22) |
| Hypocalcemia | 6 (22) | 4 (17) |
| Blood alkaline phosphatase increased | 5 (19) | 7 (30) |
| AST increased | 4 (15) | 8 (35) |
| Hyperphosphatemia | 4 (15) | 5 (22) |
| Vomiting | 4 (15) | 5 (22) |
| ALT increased | 3 (11) | 12 (52) |
| Cough | 3 (11) | 5 (22) |
| Hypoalbuminemia | 3 (11) | 8 (35) |
| Hyponatremia | 3 (11) | 10 (43) |
| Blood bilirubin increased | 2 (7) | 5 (22) |
| Hyperglycemia | 2 (7) | 6 (26) |
All AEs were coded using Medical Dictionary for Regulatory Activities, version 21.1. Multiple entries for an individual patient under each preferred term were only counted once.
ALT, alanine aminotransferase; AST, aspartate aminotransferase.