Primary and secondary efficacy outcomes
| Variable . | Arm A, n (%) . | Arm B, n (%) . | Absolute difference (95% CI) . | P value . |
|---|---|---|---|---|
| Patients, N | 76 | 79 | ||
| Primary outcome | ||||
| MMR rate at TP4 | 54 (71.1) | 61 (77.2) | 6.1 (−7.7 to 19.96) | .0016 |
| Secondary outcomes | ||||
| CR after 1 cycle | 71 (93.4) | 75 (94.9) | 1.5 (−6.69 to 10.15) | .74 |
| Arm A, n (%) | Arm B, n (%) | Hazard ratio (95% CI) | Pvalue | |
| Relapse | 11 | 24 | 2.38 (1.17 to 4.86) | .017 |
| Treatment-related death | 8 | 9 | 1.05 (0.39 to 2.79) | .93 |
| Event (either relapse or death free of relapse) | 19 | 32 | 1.81 (1.03 to 3.20) | .040 |
| Death | 15 | 20 | 1.37 (0.70 to 2.69) | .35 |
| Variable . | Arm A, n (%) . | Arm B, n (%) . | Absolute difference (95% CI) . | P value . |
|---|---|---|---|---|
| Patients, N | 76 | 79 | ||
| Primary outcome | ||||
| MMR rate at TP4 | 54 (71.1) | 61 (77.2) | 6.1 (−7.7 to 19.96) | .0016 |
| Secondary outcomes | ||||
| CR after 1 cycle | 71 (93.4) | 75 (94.9) | 1.5 (−6.69 to 10.15) | .74 |
| Arm A, n (%) | Arm B, n (%) | Hazard ratio (95% CI) | Pvalue | |
| Relapse | 11 | 24 | 2.38 (1.17 to 4.86) | .017 |
| Treatment-related death | 8 | 9 | 1.05 (0.39 to 2.79) | .93 |
| Event (either relapse or death free of relapse) | 19 | 32 | 1.81 (1.03 to 3.20) | .040 |
| Death | 15 | 20 | 1.37 (0.70 to 2.69) | .35 |
CR, complete remission; MMR, major molecular response rate; TP, time point.