Table 2.
Adverse events reported in ≥20% of patients in either arm
| Venetoclax-azacitidine (n = 24) | Placebo-azacitidine (n = 13) | |||
|---|---|---|---|---|
| AE, n (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| Any | 24 (100) | 24 (100) | 13 (100) | 12 (92.3) |
| Hematologic events | 23 (95.8) | 23 (95.8) | 11 (84.6) | 11 (84.6) |
| Thrombocytopenia | 13 (54.2) | 12 (50.0) | 10 (76.9) | 10 (76.9) |
| Neutropenia | 9 (37.5) | 9 (37.5) | 3 (23.1) | 3 (23.1) |
| Febrile neutropenia | 19 (79.2) | 19 (79.2) | 5 (38.5) | 5 (38.5) |
| Grade 3 | 18 (75.0) | 5 (38.5) | ||
| Grade 4 | 1 (4.2) | 0 | ||
| Anemia | 5 (20.8) | 5 (20.8) | 3 (23.1) | 2 (15.4) |
| Leukopenia | 8 (33.3) | 8 (33.3) | 4 (30.8) | 4 (30.8) |
| Disseminated intravascular coagulation | 1 (4.2) | 1 (4.2) | 3 (23.1) | 0 |
| Nonhematologic events | ||||
| Pneumonia | 6 (25.0) | 5 (20.8) | 2 (15.4) | 2 (15.4) |
| Nausea | 9 (37.5) | 1 (4.2) | 4 (30.8) | 0 |
| Constipation | 13 (54.2) | 0 | 7 (53.8) | 0 |
| Diarrhea | 11 (45.8) | 1 (4.2) | 6 (46.2) | 1 (7.7) |
| Vomiting | 10 (41.7) | 0 | 3 (23.1) | 0 |
| Stomatitis | 10 (41.7) | 0 | 2 (15.4) | 0 |
| Decreased weight | 6 (25.0) | 1 (4.2) | 1 (7.7) | 0 |
| Increased alanine aminotransferase | 5 (20.8) | 2 (8.3) | 1 (7.7) | 1 (7.7) |
| Hypokalemia | 6 (25.0) | 4 (16.7) | 4 (30.8) | 3 (23.1) |
| Pyrexia | 7 (29.2) | 0 | 4 (30.8) | 0 |
| Fatigue | 1 (4.2) | 0 | 1 (7.7) | 1 (7.7) |
| Decreased appetite | 13 (54.2) | 1 (4.2) | 4 (30.8) | 1 (7.7) |
| Insomnia | 6 (25.0) | 0 | 1 (7.7) | 0 |
| Malaise | 8 (33.3) | 0 | 1 (7.7) | 0 |
Abbreviation: AE, adverse event.