Moderate Adverse Event

Definition 1

An experience that is alleviated with simple therapeutic treatments. The event impacts usual daily activities. Includes laboratory test alterations indicating injury, but without long-term risk. See NCI Common Terminology Criteria for Adverse Events. (NCI Thesaurus)

Definition 2

A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. (NCI Thesaurus/CDISC)

Definition 3

An adverse event for which only minimal, local, or noninvasive intervention (e.g. packing, cautery) is indicated; or that limits instrumental activities of daily living (ADLs, e.g., shopping, laundry, transportation, or ability to conduct finances). (NCI Thesaurus)

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