Table 3.

Definitions of adverse events (AE) and reactions

Term	Definition
AE	Any untoward medical occurrence in a patient or clinical trial participant to whom a 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 AR	An AR, the nature or severity of which is not consistent with the information about the medicinal product in question set out in approved Reference Safety Information for that product in the trial.
Serious AE (SAE) or serious AR or suspected unexpected serious AR	Any AE, AR or unexpected AR 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 patient 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 inpatient admission, regardless of length of stay, even if the hospitalisation is a precautionary measure for continued observation. Hospitalisations for a pre-existing condition, that has not worsened or for an elective procedure 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; for example, a secondary malignancy, an allergic bronchospasm requiring intensive emergency treatment, seizures or blood dyscrasias that do not result in hospitalisation or development of drug dependency.