Safety assessments
diarrhea, stomatitis, toxicity, hematologic or non-hematologic toxicity, alopecia, nausea, vomiting
ALOPECIA, STOMATITIS
Clinical history, vital signs, and physical exam were performed weekly for the initial 8 weeks and then monthly. Complete blood counts and serum chemistries were performed weekly, and lipid profile and urinalysis were done monthly. Electrocardiogram was done at baseline, prior to the 1st and 2nd infusion and then every 4 weeks. Any hematologic or non-hematologic toxicity excluding alopecia that was ≥ grade 3 and suspected to be related to the investigational drug was considered a DLT. In addition, grade 3 nausea, vomiting, diarrhea or stomatitis of less than 5 day duration was not considered a DLT. A CNS toxicity ≥ grade 2 was considered a DLT.