A Serious Adverse Event (SAE) is an AE, occurring at any dose that fulfils one or more of the following: • results in death • is immediately life-threatening • requires in-patient hospitalisation or prolongation of existing hospitalisation • results in persistent or significant disability or incapacity • is a congenital abnormality/birth defect • is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above
Adverse Event (AE)
An Adverse Event (AE) is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, electrocardiogram).
