9. Definition and management of adverse events 9.1 Definition of adverse events: adverse events are defined as those occur after a patient or a subject in a clinical study receives a tested product, the event does not necessarily have a causal relationship with the test products. Adverse events are the diseases or signs or symptoms that occur during the course of the study (including abnormal laboratory findings). Adverse events can be serious or not serious, may or may not cause the subjects to withdraw from the study. All adverse events must be recorded, and the relationship between the product and the product is evaluated.