Statistical analyses
A Bayesian optimal interval design guided dose‐escalation. The safety and efficacy analyses were performed on patients who received at least one dose of venetoclax. Demographics were analyzed using descriptive statistics. DoR, OS, EFS, and TTNT were analyzed using the Kaplan–Meier methodology. Median estimates and corresponding 95% confidence intervals (CIs) were calculated.For PK, plasma concentrations of venetoclax and azacitidine were calculated for each cohort and dose level, and summary statistics were computed for each parameter.PROs were analyzed by cycle for proportions of patients whose change in scores (for EORTC‐QLQ‐C30 scales and PROMIS F) indicated meaningful improvement, deterioration, or stability. Differences in proportions were analyzed using the chi‐square test. Due to small sample sizes, data reported here are restricted to the first three post‐baseline cycles (cycles 3, 5, and 7). For the EORTC‐QLQ‐C30 scales, a threshold of five points was used, based upon the lower limit of meaningful change in scores.