Sensitivity analysis
MINOR
The summary of the laboratory assessment frequency upon simulation of missing data can be seen in S4 Table in The original laboratory data contained two consecutive measurements of the same type for 283/291 patients (data missing for eight patients who discontinued the trial early) and thus confirmed response criteria were met for these patients. In line with the BELLINI trial, the analysis of which is based on the intention-to-treat population, we also included all patients and assigned the patients with insufficient laboratory tests as non-responders. Exclusion of those patients from the analysis resulted in a minor reduction of the Cohen’s Kappa statistic from 0.83 to 0.81 in the comparison of responders and non-responders between the dR algorithm and the IRC assessment (from 0.56 to 0.55 in the case of multiple depths of response). Upon reduction of 50% or 75% of the laboratory measurements, 277/291 patients were eligible for confirmed response criteria evaluation, with the remainder (14/291) automatically assigned as non-responders.Randomly removing 50% of all laboratory measurements per patient resulted in a minor reduction in the algorithm’s accuracy in assessing the number of patients that exhibited partial response or better. In total 265 /291 assignments (54 non-responders and 211 responders) were in agreement with the IRC (Cohen’s Kappa 0.75; 