Table 3.

Maximum %LINE-1 demethylation by treatment cycle

Phase 2 overall stage cyclePatients, nTreatmentMean baseline*Maximum %LINE-1 demethylation change from baselineDifference (oral–IV) in mean maximum %LINE-1 demethylation
LSM95% CIEstimate95% CI
40 Oral C/D 79.349 10.726 9.161-12.291 −1.079 −3.320 to 1.163 
 38 IV decitabine 79.119 11.805 10.200-13.410   
31 Oral C/D 77.626 9.340 7.387-11.292 −0.017 −2.736 to 2.701 
 33 IV decitabine 77.298 9.357 7.465-11.249   
Phase 2 overall stage cyclePatients, nTreatmentMean baseline*Maximum %LINE-1 demethylation change from baselineDifference (oral–IV) in mean maximum %LINE-1 demethylation
LSM95% CIEstimate95% CI
40 Oral C/D 79.349 10.726 9.161-12.291 −1.079 −3.320 to 1.163 
 38 IV decitabine 79.119 11.805 10.200-13.410   
31 Oral C/D 77.626 9.340 7.387-11.292 −0.017 −2.736 to 2.701 
 33 IV decitabine 77.298 9.357 7.465-11.249   

C/D, cedazuridine/decitabine.

*

Baseline for cycle 1 was last available value on or before day 1 of cycle 1; baseline for cycle 2 was value on day 1 of cycle 2.

Generated using ANOVA model separately for cycles 1 and 2.

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