Safety and tolerability assessment
’ intolerance
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, ADVERSE EVENT
The safety and tolerability of AD16 were evaluated by recording the incidence and severity of adverse events during the clinical study, the incidence of serious adverse events (SAE), changes in clinical laboratory results (routine blood, biochemistry, coagulation, and urine routine), clinical symptoms, vital sign measurements, 12-lead electrocardiogram (ECG), and physical examination. Adverse events were coded using the Chinese version of MedDRA 23.0. The severity of adverse events was determined according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). The associations between adverse events and drugs were expressed in five categories: definitely, probably, possibly, unlikely related, and unrelated. During the dose escalation phase, the subjects’ intolerance was considered if more than half of the participants experienced a grade II or higher drug-related adverse event, or more than a quarter of participants suffered from grade III-IV drug-related adverse events, or upon occurrence of one drug-related SAE.