Preferred Name

adverse event

Synonyms

adverse reaction

AE

Definitions

The OAE official website is: http://www.oae-ontology.org/. a pathological bodily process that occurs after a medical intervention. An adverse event is likely caused by the medical intervention; however, such a causal association is not required to be an adverse event.

ID

http://purl.obolibrary.org/obo/OAE_0000001

comment

The OAE official website is: http://www.oae-ontology.org/.

alternative term

adverse reaction

AE

definition editor

Yongqun He

definition source

WEB: http://en.wikipedia.org/wiki/Adverse_event

WEB: http://www.ncbi.nlm.nih.gov/pubmed/25093068

WEB: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm

editor note

YH: There has been discussion regarding whether the term 'side effect' is an alternative term for 'adverse event'. In AERO, the term 'AERO:adverse event' represents a subset of those adverse events for which causality has been established. In OAE, an adverse event for which causality has been established is called 'causal adverse event'.

YH: An adverse event is a process that has specified output of some adverse medical outcome (e.g., symptom, sign or accident) after a medical intervention (or process) (e.g., administration of drug or vaccine). The medical intervention can be an administration of a drug, a vaccine (i.e., vaccination), or a special nutritional product (for example, dietary supplement, infant formula, medical food), surgery, or usage of a medical device.

YH: The main scope of OAE includes: (1) represent terms and relations in the area of adverse events, (2) assess possible associations between an adverse event and a medical intervention, particularly, identify any causal effect of a medical intervention to an adverse event; and (2) understand the mechanism (including molecular mechanisms) of causal adverse events.

YH: An adverse event is possibly induced by the medical intervention. It can be caused by the medical intervention, or may not be caused by the medical intervention. One ultimate goal (or the goal in clinics) of study adverse events is to assess if the adverse event outcome is due to the medical intervention.

Melanie Courtot and YH: More work is needed on how to restrict the scope of a term to be an 'adverse event', notably regarding temporal association. When is an appropirate time interval between a medical intervention and an adverse event observed? One week, one month, one year, or a lifetime? For some well-studied medical interventions (e.g., administration of many vaccines or drugs), we probably have a general idea. For many new interventions, we don't know much. In OAE, this issue is associated with defining the 'adverse event incubation time'.

imported from

http://purl.obolibrary.org/obo/oae.owl

label

adverse event

preceded_by

http://purl.obolibrary.org/obo/OAE_0000002

prefixIRI

OAE:0000001

prefLabel

adverse event

textual definition

a pathological bodily process that occurs after a medical intervention. An adverse event is likely caused by the medical intervention; however, such a causal association is not required to be an adverse event.

subClassOf

http://purl.obolibrary.org/obo/OGMS_0000061

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