Clinical response∗
| . | Guadecitabine (n = 408) . | TC (n = 407) . | Difference: guadecitabine vs TC (95% CI) . |
|---|---|---|---|
| CR, n (%) | 79 (19) | 71 (17) | 1.92 (−3.67 to 7.50) |
| P value† | .48 | ||
| CRc (CR + CRp and/or CRi) | 93 (23) | 91 (22) | 0.39 (−5.34 to 6.13) |
| Median duration of CR, mo (95% CI) | 7.2 (5.8-8.7) | 7.7 (6.0-9.6) | |
| Median time to best response, mo (range)‡ | 4.2 (1.4-12.4) | 3.9 (1.7-17.0) |
| . | Guadecitabine (n = 408) . | TC (n = 407) . | Difference: guadecitabine vs TC (95% CI) . |
|---|---|---|---|
| CR, n (%) | 79 (19) | 71 (17) | 1.92 (−3.67 to 7.50) |
| P value† | .48 | ||
| CRc (CR + CRp and/or CRi) | 93 (23) | 91 (22) | 0.39 (−5.34 to 6.13) |
| Median duration of CR, mo (95% CI) | 7.2 (5.8-8.7) | 7.7 (6.0-9.6) | |
| Median time to best response, mo (range)‡ | 4.2 (1.4-12.4) | 3.9 (1.7-17.0) |
IWG, International Working Group.
Response assessed based on IWG response criteria for AML by independent pathologist blinded to treatment assignment, with CRp and CRi reported separately
Cochran Mantel-Haenszel method adjusting for stratification factors used at randomization.
Best of CR, CRp, or CRi.