Baseline demographics and characteristics (TP53WT ITT population)
| Characteristic . | Idasa-C . | Placebo-C . |
|---|---|---|
| n = 232 . | n = 123 . | |
| Age, median (range), y | 63.0 (21-79) | 62.0 (27-77) |
| Male, n (%) | 121 (52.2) | 67 (54.5) |
| White, n (%) | 169 (72.8) | 92 (74.8) |
| Age group, n (%) | ||
| <60 y | 95 (40.9) | 44 (35.8) |
| ≥60 y | 137 (59.1) | 79 (64.2) |
| n = 231 | n = 123 | |
| ECOG PS, n (%) | ||
| 0 | 107 (46.3) | 61 (49.6) |
| 1 | 116 (50.2) | 60 (48.8) |
| 2 | 8 (3.5) | 2 (1.6) |
| n = 228 | n = 121 | |
| ELN 2010 classification, n (%) | ||
| Adverse | 47 (20.6) | 25 (20.7) |
| Favorable or intermediate | 181 (79.4) | 96 (79.3) |
| n = 232 | n = 123 | |
| Duration of initial response, n (%) | ||
| CR >1 y | 55 (23.7) | 30 (24.4) |
| CR ≥90 d but ≤1 y | 94 (40.5) | 46 (37.4) |
| Refractory <90 d | 83 (35.8) | 47 (38.2) |
| Prior HSCT, n (%) | 48 (20.7) | 23 (18.7) |
| Time from initial diagnosis to randomization, median (range), mo | 10.1 (0.7-89.0) | 9.5 (1.1-133.4) |
| n = 231 | n = 123 | |
| AML disease status at screening, n (%) | ||
| Refractory to first induction | 68 (29.4) | 35 (28.5) |
| Refractory to second induction | 33 (14.3) | 15 (12.2) |
| First relapse | 115 (49.8) | 65 (52.8) |
| Second relapse | 15 (6.5) | 8 (6.5) |
| Highest prior cytarabine dose, n (%)* | ||
| High | 97 (42.0) | 51 (41.5) |
| Intermediate | 34 (14.7) | 15 (12.2) |
| Conventional | 97 (42.0) | 57 (46.3) |
| Low | 3 (1.3) | 0 |
| Characteristic . | Idasa-C . | Placebo-C . |
|---|---|---|
| n = 232 . | n = 123 . | |
| Age, median (range), y | 63.0 (21-79) | 62.0 (27-77) |
| Male, n (%) | 121 (52.2) | 67 (54.5) |
| White, n (%) | 169 (72.8) | 92 (74.8) |
| Age group, n (%) | ||
| <60 y | 95 (40.9) | 44 (35.8) |
| ≥60 y | 137 (59.1) | 79 (64.2) |
| n = 231 | n = 123 | |
| ECOG PS, n (%) | ||
| 0 | 107 (46.3) | 61 (49.6) |
| 1 | 116 (50.2) | 60 (48.8) |
| 2 | 8 (3.5) | 2 (1.6) |
| n = 228 | n = 121 | |
| ELN 2010 classification, n (%) | ||
| Adverse | 47 (20.6) | 25 (20.7) |
| Favorable or intermediate | 181 (79.4) | 96 (79.3) |
| n = 232 | n = 123 | |
| Duration of initial response, n (%) | ||
| CR >1 y | 55 (23.7) | 30 (24.4) |
| CR ≥90 d but ≤1 y | 94 (40.5) | 46 (37.4) |
| Refractory <90 d | 83 (35.8) | 47 (38.2) |
| Prior HSCT, n (%) | 48 (20.7) | 23 (18.7) |
| Time from initial diagnosis to randomization, median (range), mo | 10.1 (0.7-89.0) | 9.5 (1.1-133.4) |
| n = 231 | n = 123 | |
| AML disease status at screening, n (%) | ||
| Refractory to first induction | 68 (29.4) | 35 (28.5) |
| Refractory to second induction | 33 (14.3) | 15 (12.2) |
| First relapse | 115 (49.8) | 65 (52.8) |
| Second relapse | 15 (6.5) | 8 (6.5) |
| Highest prior cytarabine dose, n (%)* | ||
| High | 97 (42.0) | 51 (41.5) |
| Intermediate | 34 (14.7) | 15 (12.2) |
| Conventional | 97 (42.0) | 57 (46.3) |
| Low | 3 (1.3) | 0 |
ECOG PS, Eastern Cooperative Oncology Group performance status.
High dose = ≥2 g/m2; intermediate dose = 0.5 to <2.0 g/m2; conventional dose = 0.1 to <0.5 g/m2; and low dose = <0.1 g/m2.