Table 4. International Conference on Harmonization (ICH) Good Clinical Practice (GCP) definitions.

Table	Definition
Adverse event (AE)	Any untoward medical occurrence in a participant or clinical trial subject to whom an investigational medicinal product has been administered including occurrences that are not necessarily caused by or related to that product.
Adverse reaction (AR)	Any untoward and unintended response to an investigational medicinal product related to any dose administered.
Unexpected adverse reaction (UAR)	An AR, the nature or severity of which is not consistent with the information about the investigational medicinal product in question set out in the Summary of Product Characteristics (SPC) for that product.
Serious adverse event (SAE) or serious adverse reaction (SAR) or suspected unexpected serious adverse reaction (SUSAR)	Respectively any AE, AR or UAR that: Results in death Is life-threatening * Requires hospitalisation or prolongation of existing hospitalisation ** Results in persistent or significant disability or incapacity Consists of a congenital anomaly or birth defect Is another important medical condition ***

^* The term life-threatening in the definition of a serious event refers to an event in which the participant is at risk of death at the time of the event; it does not refer to an event that hypothetically might cause death if it were more severe, for example, a silent myocardial infarction.

^** Hospitalisation is defined as an inparticipant admission, regardless of length of stay, even if the hospitalisation is a precautionary measure for continued observation. Hospitalisations for a pre-existing condition (including elective procedures that have not worsened) do not constitute an SAE.

^*** Medical judgement should be exercised in deciding whether an AE or AR is serious in other situations. The following should also be considered serious: important AEs or ARs that are not immediately life-threatening or do not result in death or hospitalisation but may jeopardise the subject or may require intervention to prevent one of the other outcomes listed in the definition above.