Preferred Label : Signal of a Serious Risk;
Alternative definition : CDISC-GLOSS: Information related to a serious adverse drug experience associated with
use of a drug and derived from-(a) a clinical trial; (b) adverse event reports; (c)
a post-approval study; (d) peer-reviewed biomedical literature; (e) data derived from
the post-market REMs. [505-1(b) of FD&C Act (21 USC. 355-1(b)];
NCI Metathesaurus CUI : CL540601;
Origin ID : C142688;
UMLS CUI : C4684774;
Semantic type(s)
- concept_is_in_subset
