•Diarrhea was the primary DLT and was reversible via dose holding,dose-reduction,and non-mandatory anti-diarrhea medications including loperamide in early stage and pivotal clinical trials.
•Diarrhea was the primary DLT and was reversible via dose holding,dose-reduction,and non-mandatory anti-diarrhea medications including loperamide in early stage and pivotal clinical trials.