Preferred Label : Unexpected Serious Risk;
NCIt definition : A serious adverse drug experience that is not listed in the labeling of a drug, or
that may be symptomatically or pathophysiologically related to an adverse drug experience
identified in the labeling, but differs because of greater severity, specificity,
or prevalence. [505-1(b) of FD&C Act (21 USC. 355-1(b);
Alternative definition : CDISC-GLOSS: A serious adverse drug experience that is not listed in the labeling
of a drug, or that may be symptomatically or pathophysiologically related to an adverse
drug experience identified in the labeling, but differs because of greater severity,
specificity, or prevalence. [505-1(b) of FD&C Act (21 USC. 355-1(b)];
NCI Metathesaurus CUI : CL540655;
Origin ID : C142745;
UMLS CUI : C4684809;
Semantic type(s)
- concept_is_in_subset
