Data Set EHR4CR2ELGA - Concept Seriousness of Adverse Event

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Name	ID[‑]	Datatype[‑]	Property[‑]	Example[‑]	Codes[‑]	Description[‑]	Source[‑]	Rationale[‑]	Operationalizations[‑]	Comment[‑]	Status[‑]	Terminology[‑]	Value Set[‑]	Type[‑]	Parent concept[‑]	Inherit from[‑]
Seriousness of Adverse Event	ehr4cr2elga-dataelement-203	String				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.					draft			Item		ehr4cr-dataelement-230