Adverse Event Expected Indicator

**Semantic type:** Qualitative Concept

**Definition:** Specifies whether the nature, frequency, or severity of an adverse event is consistent with the applicable study documentation (e.g., investigator's brochure, protocol document, or consent document) or product labeling (package insert).

**Synonyms:** - AE_EXPECTED - AdverseEvent.expectedIndicator - AdverseEvent.expectedIndicator