Preferred Label : Other Medically Important Serious Event;
NCIt related terms : other serious (important medical events); SMIE;
NCIt definition : A serious adverse event that does not meet the criteria for being life threatening,
requiring inpatient hospitalization, or causing death, persistent or significant disability
or incapacity, cancer, or a congenital anomaly or birth defect, but may require medical
or surgical intervention to prevent one or more of those outcomes.;
Alternative definition : CDISC-GLOSS: A category of important medical events that may not be immediately life-threatening,
result in death, or hospitalization, but may jeopardize the patient or may require
intervention to prevent one of the outcomes criteria events requiring assessment for
potential regulatory reporting as a serious adverse event. Note: These Other serious
events require medical and scientific judgement in evaluating the need for reporting
as a serious adverse event. Examples include allergic bronchospasm (a serious problem
with breathing) requiring treatment in an emergency room, serious blood dyscrasias
(blood disorders) or seizures/convulsions that do not result in hospitalization. The
development of drug dependence or drug abuse would also be examples of important medical
events. [after FDA 310.305, ICH E2A] See also serious adverse event.;
Origin ID : C82521;
UMLS CUI : C2826256;
Semantic type(s)
- Event [UMLS semantic type]
- concept_is_in_subset
