Safety and tolerability assessments
toxicity, Toxicity
ADVERSE EVENT, ADVERSE EVENT
Adverse events (AEs; i.e., toxicity) were carefully monitored during the course of the study by the physician‐investigators. The assessment of safety and tolerability was based on the observed toxicity according to type and grade. Toxicity assessments were made every 6 weeks at the timepoint of beginning the alternate drug treatment within a cycle. Rates of serious grade 3 or worse toxicity were computed as defined by the NCI's Common Terminology Criteria for Adverse Events Version 4.0.