What's clinical adverse event and it's classification？
Clinical adverse events (AEs) are defined as any unfavorable or unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medical product, whether related to or not related to such product.
AEs can be classified by severity into five categories:
1) Mild AEs: No intervention is required; no discomfort; no incapacity; no inconvenience; no hospitalization.
2) Moderate AEs: Intervention needed for recovery/relief; some limitation on daily activities; some incapacity; some inconvenience; possible hospitalization.
3) Severe AEs: Inpatient treatment; life-threatening; prolonged or permanent incapacity; prolonged or permanent incapacity; hospitalization for observation.
4) Life-threatening AEs: Events that result in death.
5) Death: AEs related death.
