Preferred Label : Expected Adverse Event;
NCIt synonyms : EAE; Anticipated Adverse Event;
NCIt related terms : Expected;
NCIt definition : Any adverse event associated with a medical product or procedure, whose nature and
severity have been previously observed, identified in nature, severity, or frequency,
and documented in the investigator brochure, investigational plan, protocol, current
consent form, scientific publication, or in other relevant and reliable document.
The old term Side Effect is retired and should not be used.;
Alternative definition : CDISC-GLOSS: Other adverse events that are not study endpoints and are not expected
(i.e., because they are not in the investigator's brochure) that can be anticipated
to occur with some frequency during the course of the trial, regardless of drug exposure,
depending on the patient population and disease under study. NOTE: Examples of such
anticipated events include known consequences of the underlying disease or condition
under investigation, events anticipated from any background regimen, or re-emergence
or worsening of a condition relative to pretreatment baseline. [after FDA, Guidance
for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies];
Origin ID : C41333;
UMLS CUI : C1517002;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
