Efficacy and early safety outcomes by treatment group
| . | Total (N = 100) . | VenAza (n = 44) . | ICH (n = 56) . | P value . |
|---|---|---|---|---|
| Efficacy outcomes | .01 | |||
| Response (ORR) (n = 76), n (%) | 52 (68.4) | 22 (59.5) | 30 (76.9) | .1 |
| Composite CR/CRh/CRi (n = 76), n (%) | 47 (61.8) | 17 (45.9) | 30 (76.9) | .005 |
| Composite CR/CRh/CRi/MLFS | 51 (67.1) | 21 (56.8) | 30 (76.9) | .06 |
| ELN response category (n = 76), n (%) | .01 | |||
| CR | 40 (52.6) | 12 (32.4) | 28 (71.8) | |
| CRh | 2 (2.6) | 2 (5.4) | 0 (0) | |
| CRi | 5 (6.6) | 3 (8.1) | 2 (5.1) | |
| MLFS | 4 (5.3) | 4 (10.8) | 0 (0) | |
| Partial response | 1 (1.3) | 1 (2.7) | 0 (0) | |
| No response | 24 (31.6) | 15 (40.5) | 9 (23.1) | |
| MRD status n (%) | .16 | |||
| Negative MRD | 24 (70.6) | 13 (61.9) | 11 (84.6) | |
| Positive MRD | 10 (29.4) | 8 (38.1) | 2 (15.4) | |
| Safety and early outcomes | ||||
| Hospitalization, n (%) | .0001 | |||
| Ambulatory | 23 (23) | 22 (50) | 1 (1.8) | |
| Hospitalization | 77 (77) | 22 (50) | 55 (98.2) | |
| Hospitalization, median (range), d | 25 (3-86) | 14 (5-65) | 28 (3-86) | .0001 |
| Complications (n = 98), n (%) | 77 (78.6) | 24 (54.5) | 53 (98.1) | .0001 |
| Neutropenic fever (n = 97), n (%) | 70 (72.2) | 22 (50) | 48 (90.6) | .0001 |
| Sepsis n (%) | 41 (41) | 17 (38.6) | 24 (42.9) | .67 |
| Bleeding (n = 97), n (%) | 8 (8.2) | 4 (9.1) | 4 (7.5) | .78 |
| . | Total (N = 100) . | VenAza (n = 44) . | ICH (n = 56) . | P value . |
|---|---|---|---|---|
| Efficacy outcomes | .01 | |||
| Response (ORR) (n = 76), n (%) | 52 (68.4) | 22 (59.5) | 30 (76.9) | .1 |
| Composite CR/CRh/CRi (n = 76), n (%) | 47 (61.8) | 17 (45.9) | 30 (76.9) | .005 |
| Composite CR/CRh/CRi/MLFS | 51 (67.1) | 21 (56.8) | 30 (76.9) | .06 |
| ELN response category (n = 76), n (%) | .01 | |||
| CR | 40 (52.6) | 12 (32.4) | 28 (71.8) | |
| CRh | 2 (2.6) | 2 (5.4) | 0 (0) | |
| CRi | 5 (6.6) | 3 (8.1) | 2 (5.1) | |
| MLFS | 4 (5.3) | 4 (10.8) | 0 (0) | |
| Partial response | 1 (1.3) | 1 (2.7) | 0 (0) | |
| No response | 24 (31.6) | 15 (40.5) | 9 (23.1) | |
| MRD status n (%) | .16 | |||
| Negative MRD | 24 (70.6) | 13 (61.9) | 11 (84.6) | |
| Positive MRD | 10 (29.4) | 8 (38.1) | 2 (15.4) | |
| Safety and early outcomes | ||||
| Hospitalization, n (%) | .0001 | |||
| Ambulatory | 23 (23) | 22 (50) | 1 (1.8) | |
| Hospitalization | 77 (77) | 22 (50) | 55 (98.2) | |
| Hospitalization, median (range), d | 25 (3-86) | 14 (5-65) | 28 (3-86) | .0001 |
| Complications (n = 98), n (%) | 77 (78.6) | 24 (54.5) | 53 (98.1) | .0001 |
| Neutropenic fever (n = 97), n (%) | 70 (72.2) | 22 (50) | 48 (90.6) | .0001 |
| Sepsis n (%) | 41 (41) | 17 (38.6) | 24 (42.9) | .67 |
| Bleeding (n = 97), n (%) | 8 (8.2) | 4 (9.1) | 4 (7.5) | .78 |
CRh, CR with partial hematologic recovery; MLFS, morphologic leukemia-free state.