What are adverse events?

Adverse event (AE) refers to any adverse event that may occur to the subject in the clinical trial and may be related to the trial treatment and trial treatment.

Medical events related or not necessarily related to the tested drugs. Therefore, an adverse event can be any adverse or unexpected signs (including abnormal laboratory test results), symptoms or a kind of signs that may or may not be related to the test drug-a temporary disease that may be related to the use of drugs. The recording of adverse events is an important means to evaluate the safety of drugs used in trials. Therefore, at each follow-up visit, the investigator should ask the subject about any adverse events in detail. Although some adverse events were spontaneously reported by the subjects to the researchers, most trials still required the researchers to collect the occurrence of adverse events from the subjects through non inductive questions, such as "is there any discomfort after taking medicine?". In case of any adverse event, including the known adverse reaction of the trial drug, whether related to the trial drug or not, the investigator shall record it in detail in the case report form according to the requirements of the trial protocol.