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.