TEAEs by preferred term in at least 20% of patients by dose level
| . | Dose level 1 (n = 4) . | Dose level 2 (n = 7) . | Dose level 1b (n = 24) . | Overall (N = 35) . |
|---|---|---|---|---|
| Any TEAE,∗ n (%) | 4 (100.0) | 7 (100.0) | 24 (100.0) | 35 (100.0) |
| Nausea | 0 | 2 (28.6) | 13 (54.2) | 15 (42.9) |
| Thrombocytopenia | 2 (50.0) | 1 (14.3) | 11 (45.8) | 14 (40.0) |
| Febrile neutropenia | 1 (25.0) | 4 (57.1) | 8 (33.3) | 13 (37.1) |
| Neutropenia | 2 (50.0) | 3 (42.9) | 7 (29.2) | 12 (34.3) |
| Anemia | 1 (25.0) | 2 (28.6) | 8 (33.3) | 11 (31.4) |
| Peripheral edema | 3 (75.0) | 1 (14.3) | 7 (29.2) | 11 (31.4) |
| Constipation | 3 (75.0) | 2 (28.6) | 6 (25.0) | 11 (31.4) |
| Hypokalemia | 0 | 0 | 8 (33.3) | 8 (22.9) |
| Diarrhea | 2 (50.0) | 2 (28.6) | 4 (16.7) | 8 (22.9) |
| Dyspnea | 0 | 3 (42.9) | 5 (20.8) | 8 (22.9) |
| Headache | 0 | 1 (14.3) | 7 (29.2) | 8 (22.9) |
| Decreased appetite | 1 (25.0) | 1 (14.3) | 5 (20.8) | 7 (20.0) |
| Cough | 1 (25.0) | 1 (14.3) | 5 (20.8) | 7 (20.0) |
| Epistaxis | 1 (25.0) | 0 | 6 (25.0) | 7 (20.0) |
| . | Dose level 1 (n = 4) . | Dose level 2 (n = 7) . | Dose level 1b (n = 24) . | Overall (N = 35) . |
|---|---|---|---|---|
| Any TEAE,∗ n (%) | 4 (100.0) | 7 (100.0) | 24 (100.0) | 35 (100.0) |
| Nausea | 0 | 2 (28.6) | 13 (54.2) | 15 (42.9) |
| Thrombocytopenia | 2 (50.0) | 1 (14.3) | 11 (45.8) | 14 (40.0) |
| Febrile neutropenia | 1 (25.0) | 4 (57.1) | 8 (33.3) | 13 (37.1) |
| Neutropenia | 2 (50.0) | 3 (42.9) | 7 (29.2) | 12 (34.3) |
| Anemia | 1 (25.0) | 2 (28.6) | 8 (33.3) | 11 (31.4) |
| Peripheral edema | 3 (75.0) | 1 (14.3) | 7 (29.2) | 11 (31.4) |
| Constipation | 3 (75.0) | 2 (28.6) | 6 (25.0) | 11 (31.4) |
| Hypokalemia | 0 | 0 | 8 (33.3) | 8 (22.9) |
| Diarrhea | 2 (50.0) | 2 (28.6) | 4 (16.7) | 8 (22.9) |
| Dyspnea | 0 | 3 (42.9) | 5 (20.8) | 8 (22.9) |
| Headache | 0 | 1 (14.3) | 7 (29.2) | 8 (22.9) |
| Decreased appetite | 1 (25.0) | 1 (14.3) | 5 (20.8) | 7 (20.0) |
| Cough | 1 (25.0) | 1 (14.3) | 5 (20.8) | 7 (20.0) |
| Epistaxis | 1 (25.0) | 0 | 6 (25.0) | 7 (20.0) |
Dose level 1 included CPX-351, daunorubicin 8.8 mg/m2, and cytarabine 20 mg/m2 on days 1 and 3, plus venetoclax 400 mg on days 2 to 21. Dose level 2 included CPX-351, daunorubicin 17.6 mg/m2, and cytarabine 40 mg/m2 on days 1 and 3, plus venetoclax 400 mg on days 2 to 21. Dose level 1b included CPX-351, daunorubicin 13.2 mg/m2, and cytarabine 30 mg/m2 on days 1 and 3, plus venetoclax 400 mg on days 2 to 21.
Preferred terms are sorted in descending order of incidence in ≥20% of patients in the overall study population. Multiple entries for an individual patient under each preferred term were only counted once.