Table 4 Safety reporting definitions

Adverse event (AE)^a

Any untoward medical occurrence in a patient or clinical trial subject 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 adverse reaction (UAR)

An adverse reaction, the nature or severity of which is not consistent with the information about the medicinal product in question set out in the Summary of Product Characteristics (SPC) or Investigator Brochure (IB) for that product

Serious adverse event (SAE) or serious adverse reaction (SAR) or suspected unexpected serious adverse reaction (SUSAR)

Respectively, any adverse event, adverse reaction or unexpected adverse reaction 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