Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms (CAA) in Kawasaki disease (KD): the KD CAA prevention (KD-CAAP) trial protocol

Table 7 Adverse events definitions

Term	Definition
Adverse event (AE)	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, as 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)	Any adverse event, adverse reaction or unexpected adverse reaction that: Results in death Is life-threatening^a Requires hospitalisation or prolongation of existing hospitalisation^b Results in persistent or significant disability or incapacity Consists of a congenital anomaly or birth defect Is another important medical condition^c

^a 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
^b Hospitalisation is defined as an inpatient admission, regardless of length of stay, even if the hospitalisation is a precautionary measure for continued observation
^c 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

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