Table 4.

Safety reporting definitions

Term	Definition
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

^aAEs will include; an exacerbation of a pre-existing illness, an increase in frequency or intensity of a pre-existing episodic event or condition, a condition (even though it may have been present prior to the start of the trial) detected after trial drug administration or continuous persistent disease (or a symptom present at baseline) that worsens following administration of the study treatment

Conditions exempted from AEs will include; medical or surgical procedures (the condition that leads to the procedure is the adverse event), pre-existing disease or a condition present before treatment that does not worsen, hospitalisations where no untoward or unintended response has occurred (e.g. elective cosmetic surgery, social admissions) or overdose of medication without signs or symptoms