Safety and tolerability assessments
Cancer
ADVERSE REACTIONS, ADVERSE EVENT, CANCER
Safety was assessed in all enrolled participants. Measures of safety included the assessment of the occurrence of treatment-emergent AEs (TEAEs) and serious AEs, as well as noting clinically significant changes from baseline in vital signs (blood pressure, pulse rate, body temperature, and respiratory rate), physical examinations, electrocardiograms, and laboratory assessments (hematology panel, chemistry panel, urinalysis, coagulation panel, pregnancy test, drug screen). Infusion-related reactions were characterized as adverse reactions that were judged by the investigator to be in response to the infusion. All clinically significant laboratory value abnormalities were recorded as AEs, and any abnormal values that persisted were followed up on where directed by the investigator. Whenever possible, the severity of AEs was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.