Safety assessment
Cancer
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, CANCER
Safety assessments included AEs, treatment-emergent AEs (TEAEs), serious adverse events (SAEs), clinical laboratory parameters (hematology, blood chemistry, and urinalysis), vital signs, electrocardiogram parameters, and physical examinations.Adverse events and SAEs were collected from the date of informed consent until 30 days after the completion of the study. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities version 20.1. The severity of AEs was graded based on the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.All laboratory tests used for statistical analyses were performed by a designated central laboratory to ensure consistent measurements throughout the study duration.Immunogenicity was also evaluated.