An ‘adverse event’ (AE) is any untoward (i.e. unfavourable and unintended) medical occurrence in a research subject.
It may or may not be caused by any research procedures or interventions, but is nonetheless given importance because its timing of occurrence corresponded with the study.
Medical occurrences that constitute an AE can be any symptoms, signs, abnormal investigation findings, diseases, injuries, health conditions, or worsening of pre-existing health conditions.
A ‘serious adverse event’ (SAE) is an adverse event that: (1)
Figure 1 Serious adverse events (SAE) (Source: ICH, 1994) (CC BY-SA)
The importance of recognising AEs and SAEs (1) →
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting: ICH E2A [Internet]. [cited 2019 Jan 22]. Available from: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-safety-data-management-definitions-and-standards-for-expedited-reporting.html