Summary of response rates and efficacy end points
| End point . | % (95% CI) . | P . | |
|---|---|---|---|
| Placebo + LDAC (n = 68) . | Venetoclax + LDAC (n = 143) . | ||
| Remission rate | |||
| CR* | 7 (2-16) | 27 (20-35) | <.001 |
| CR/CRi† | 13 (6-24) | 48 (39-56) | <.001 |
| By initiation of cycle 2 | 3 (0-10) | 34 (27-43) | <.001 |
| CR/CRh‡ | 15 (7-25) | 47 (39-55) | <.001 |
| By initiation of cycle 2 | 4 (1-12) | 31 (23-39) | <.001 |
| Other | |||
| EFS, mo | .002 | ||
| Median | 2.0 | 4.7§ | |
| 95% CI | 1.6-3.1 | 3.7-6.4 | |
| Transfusion independence | |||
| Red blood cells | 18 (10-29) | 41 (32-49) | .001 |
| Platelets | 32 (22-45) | 48 (39-56) | .040 |
| Both | 16 (8-27) | 37 (29-46) | .002 |
| End point . | % (95% CI) . | P . | |
|---|---|---|---|
| Placebo + LDAC (n = 68) . | Venetoclax + LDAC (n = 143) . | ||
| Remission rate | |||
| CR* | 7 (2-16) | 27 (20-35) | <.001 |
| CR/CRi† | 13 (6-24) | 48 (39-56) | <.001 |
| By initiation of cycle 2 | 3 (0-10) | 34 (27-43) | <.001 |
| CR/CRh‡ | 15 (7-25) | 47 (39-55) | <.001 |
| By initiation of cycle 2 | 4 (1-12) | 31 (23-39) | <.001 |
| Other | |||
| EFS, mo | .002 | ||
| Median | 2.0 | 4.7§ | |
| 95% CI | 1.6-3.1 | 3.7-6.4 | |
| Transfusion independence | |||
| Red blood cells | 18 (10-29) | 41 (32-49) | .001 |
| Platelets | 32 (22-45) | 48 (39-56) | .040 |
| Both | 16 (8-27) | 37 (29-46) | .002 |
Bone marrow with <5% blasts, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count ≥103/μL, platelets ≥100 × 109/L, and red cell transfusion independence.
All criteria for CR except absolute neutrophil count <103/μL or platelets <100 × 109/L ± red cell transfusion independence.
‡Bone marrow with <5% blasts, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >0.5 × 103/μL, and platelets >50 × 109/L.
HR, 0.58 (95% CI, 0.42-0.82).