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 using 50% of all available laboratory measurements.
MINOR
*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.Excluding 75% of urine M protein measurements, 50% of serum M protein, and 50% of FLC records per patient also resulted in a minor reduction in the algorithm’s accuracy in assessing the number of patients with ≥PR when compared with IRC assessment, with 265/291 assignments in agreement (Cohen’s Kappa 0.75; 