Seriousness of Adverse Event

**Semantic type:** Qualitative Concept

**Definition:** Clinical significance of adverse event defined based on the patient and event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning. Seriousness of adverse event serves as a primary guide for defining regulatory reporting obligations and changes in medicinal product development and usage.

**Synonyms:** - AESER - AdverseEventSeriousness - AdverseEventSeriousness