Preferred Label : Unexpected Adverse Drug Reaction;
NCIt definition : An adverse drug reaction, whose nature, severity, specificity, or outcome is not consistent
with the term or description used in the applicable product information (e.g., IB
for an unapproved investigational product or PI/summary of product characteristics
for an approved product, and/or scientific literature). (ICH);
Alternative definition : CDISC-GLOSS: An adverse drug reaction, whose nature, severity, specificity, or outcome
is not consistent with the term or description used in the applicable product information
(e.g., IB for an unapproved investigational product or PI/summary of product characteristics
for an approved product, and/or scientific literature). [After ICH E6 (R2)];
NCI Metathesaurus CUI : CL540656;
Origin ID : C142744;
UMLS CUI : C4553915;
Semantic type(s)
- concept_is_in_subset
