adverse event

An adverse event is an undesirable, unfavorable and unintended medical occurrence presenting in a predetermined time frame following administration of a compound or usage of a device

obo:AERO_0000009

http://purl.obolibrary.org/obo/AERO_0000009

I initialy made adverse event a defined class: is_a sign and preceded by administration. However, by doing so, and as the range of preceded by is processual entities, I was implicitely making adverse event a subclass of processual entity, therfore making adverse event rash (a continuant) inconsistent.

An adverse event is an undesirable, unfavorable and unintended medical occurrence presenting in a predetermined time frame following administration of a compound or usage of a device

ICH Topic E 2 A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

adverse event