Statistical analyses
toxicity, PD
REGRESSION
Bayesian logistic regression model based on dose-limiting toxicity was used to provide initial guidance for dose recommendations in the dose-escalation phase. The final decision was reached by considering the totality of safety, PK, and PD data. For binary efficacy endpoints, two-sided 95% Clopper–Pearson exact confidence intervals were provided. For time-to-event endpoints (PFS and OS), the median and 95% CI were estimated using the Kaplan–Meier method.