Statistical Analysis
DLTs
Patient baseline characteristics and AEs were summarized, and the number of patients treated at each dose level and their DLTs were tabulated. AEs were tabulated by type and grade. The best objective response and time to progression were plotted for individual patients. Kaplan–Meier curves were plotted for progression-free survival and OS. A pairwise Wilcoxon signed-rank test was used for FACT-G QoL.