Table 2.
Summary of treatment-emergent AEs by frequency across all patients
| AE | n (%) | |
|---|---|---|
| Placebo + LDAC (n = 68) | Venetoclax + LDAC (n = 142) | |
| Hematologic (grade ≥3)* | ||
| Thrombocytopenia | 25 (37) | 64 (45) |
| Neutropenia | 11 (16) | 66 (46) |
| Febrile neutropenia | 20 (29) | 45 (32) |
| Anemia | 15 (22) | 36 (25) |
| Nonhematologic (any grade)* | ||
| Nausea | 21 (31) | 60 (42) |
| Hypokalemia | 15 (22) | 40 (28) |
| Diarrhea | 11 (16) | 40 (28) |
| Constipation | 21 (31) | 26 (18) |
| Vomiting | 9 (13) | 36 (25) |
| Pneumonia | 11 (16) | 29 (20) |
| Edema peripheral | 14 (21) | 19 (13) |
| Selected key AML serious AEs | ||
| Febrile neutropenia | 12 (18) | 23 (16) |
| Pneumonia | 7 (10) | 18 (13) |
| Sepsis | 4 (6) | 8 (6) |
| Thrombocytopenia | 2 (3) | 7 (5) |
| Anemia | 0 | 4 (3) |
| Neutropenia | 0 | 4 (3) |
*
AEs shown were reported in ≥20% of patients in either treatment arm.