Statistical analysis
death, Tumor
ADVERSE EVENT, TUMOR
The maximum tolerated dose was defined as the highest DL among those tested where at most 1 out of 6 patients developed a DLT, and the next highest DL was such that 2 of the 3 to 6 patients treated at this DL developed a DLT. Adverse events were summarized in frequency tables. Tumor responses were summarized by simple descriptive summary statistics. OS was defined as the time from registration to death due to any cause and was estimated with Kaplan-Meier (KM) curves.