SAE/SADR definition
SAE/SADR means Serious Adverse Event/Serious Adverse Drug Reaction, an adverse drug experience/event/reaction occurring at any dose which
a) results in death,
b) is life-threatening, *Life-threatening refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if more severe.
c) requires inpatient hospitalisation or prolongation of existing hospitalisation;
d) results in persistent or significant disability/incapacity;
e) is a congenital anomaly/birth defect;
f) an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalisation but, based on appropriate medical and scientific judgment, may jeopardise the patient/subject or may require intervention (e.g.. medical and/or surgical) to prevent one of the other outcomes listed in the definition above.) Examples of such include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias; or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse. Any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction. A common Medically Important List will be adopted by both companies for medical events which should be considered as serious.