Analysis of the differences in overall response rate, ≥VGPR and ≥CR in the intervention and placebo arms of the BELLINI trial by IRC and the dR algorithm.
*Nominal p-values without multiple hypotheses correction are shown for completeness and serve to compare the estimated treatment effect between dR and IRC.CI, confidence interval; CMH, Cochran-Mantel-Haenszel; CR, complete response; dR, derived response; IRC, independent review committee; ORR, overall response rate; VGPR, very good partial response.We then tested if the algorithm could be reliably used in the evaluation of other common endpoints such as ≥VGPR and ≥CR. Characterization of ≥VGPR by the algorithm was consistent with the IRC’s assessment (≥VGPR in intervention vs. placebo arms by IRC: 59% [114/194] vs. 36% [35/97], OR 2.48; by dR: 60% [116/194] vs. 37% [36/97], OR 2.49; 