Table 1.
Patient demographics and clinical characteristics
| Characteristic | n/N (%) | |
|---|---|---|
| Placebo + LDAC (n = 68) | Venetoclax + LDAC (n = 143) | |
| Age, y | ||
| Median | 76 | 76 |
| Range | 41-88 | 36-93 |
| ≥75 | 40 (59) | 82 (57) |
| Male sex | 39 (57) | 78 (55) |
| AML type | ||
| De novo | 45 (66) | 85 (59) |
| Secondary | 23 (34) | 58 (41) |
| Secondary AML type | ||
| Therapy related | 4/23 (17) | 6/58 (10) |
| Prior hematologic disorder | 19/23 (83) | 52/58 (90) |
| ECOG performance status | ||
| 0 | 11 (16) | 22 (15) |
| 1 | 23 (34) | 52 (36) |
| 2 | 25 (37) | 63 (44) |
| 3 | 9 (13) | 6 (4) |
| Bone marrow blast count, % | ||
| <30 | 18 (27) | 42 (29) |
| ≥30 to <50 | 22 (32) | 36 (25) |
| ≥50 | 28 (41) | 65 (46) |
| Antecedent hematologic disorder | 17 (25) | 47 (33) |
| Prior HMA treatment | 14 (21) | 28 (20) |
| Cytogenetic risk category | ||
| Favorable | 3 (4) | 1 (1) |
| Intermediate | 43 (63) | 90 (63) |
| Poor | 20 (29) | 47 (33) |
| No mitosis/missing | 2 (3) | 5 (3) |
| Somatic mutation* | ||
| TP53 | 9 (17) | 22 (20) |
| FLT3 | 9 (17) | 20 (18) |
| IDH1/2 | 12 (23) | 21 (19) |
| NPM1 | 7 (14) | 18 (16) |
| Transfusion dependent at baseline† | ||
| Red blood cells | 53 (78) | 104 (73) |
| Platelets | 24 (35) | 53 (37) |
*
Mutation data missing for 16 and 31 patients in placebo and venetoclax arms, respectively; percentage calculated based on n of patients with data.
†
Underwent transfusion within 8 wk before first dose of study drug.