Preferred Label : Unexpected Adverse Event;
NCIt synonyms : UAE;
NCIt related terms : unexpected adverse drug reaction; Unexpected; Unanticipated Adverse Event;
NCIt definition : Any adverse event associated with a medical product or procedure that has not been
previously observed, whether or not the event was anticipated because of the pharmacologic
properties of the study agent or the nature of the medical procedure. This includes
events that are more serious than expected or occur more frequently than expected,
particularly, any adverse experience, the nature, severity or frequency of which is
not consistent with the product label, or with the current investigator brochure for
investigational agent; or with the risk information described in the investigational
plan or protocol or consent form.;
Alternative definition : CDISC: An adverse reaction, whose nature, severity, specificity, or outcome is not
consistent with the term or description used in the applicable product information.
[ICH E2] See also adverse drug reaction.;
Origin ID : C41334;
UMLS CUI : C1519789;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
