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Serious adverse event or serious suspected adverse reaction: Death. A life-threatening adverse event. Inpatient hospitalization, or prolonged of existing hospitalization. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.

From ICH E2A and E6, “investigational” term only in E6] • An adverse event is any untoward or unfavorable medical occurrence in a human. subject, including any abnormal sign (for example, abnormal physical exam or. laboratory finding), symptom, or disease, temporally associated with the subject's.

Adverse Event - An event in which care resulted in an undesirable clinical outcome-an outcome not caused by underlying disease-that prolonged the patient stay, caused permanent patient harm, required life-saving intervention, or contributed to death.

Adverse events (AE) frequently occur in any medical system, and at least one in ten patients are affected. [1] An AE is a harmful and negative outcome that happens when a patient has been provided with medical care. [2] Medical treatment may include a procedure, surgery, or medication.

Adverse Event: An incident that has resulted in harm to the patient as a result of the care provided in the OHP (also known as a “harmful incident”). For specific examples, please see the Advice to the Profession document.