Safety monitoring
ADVERSE EVENTS, EVENTS, EVENT, ADVERSE EVENT
In this study, we will assess and gather adverse event data according to NCI-CTCAE version 5.0 and then perform a causality assessment. Severe adverse events will be reported to the principal investigator within 24 h after primary recognition of the event by the researcher. Likewise, severe adverse events will also be reported to the IRB within the time frame designated by the IRB guidelines. Medical issues directly related to the events that may occur during this clinical trial will be compensated for in accordance with the clinical research agreement and insurance.