disorder resulting from an adverse event process 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 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. ICH Topic E 2 A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting adverse event process