Assessment of adverse reactions and drug tolerability
toxicity
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE REACTIONS, ADVERSE EVENT
To examine possible adverse events (AEs) and adverse reactions (an adverse event is definitely, probably, or possibly related to the drug) in this study, the recruited patients underwent regular clinical laboratory testing, 12-lead electrocardiograms, examination of vital signs, abdominal ultrasound, and regular physical examinations, using the baseline data as a control. The severity of AEs and laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, which defines toxicity criteria. The AEs were coded using the Medical Dictionary for Regulatory Activities, version 24.1 (McLean, VA, USA).