Definition of SAEs Sample Clauses

Definition of SAEs. A SAE is defined as an adverse event that meets at least 1 of the following serious criteria: • Fatal • Life-threatening (places the subject at immediate risk of death) • Requires in-patient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity • Congenital anomaly/birth defect • Other medically important serious event An AE would meet the criterion of “requires hospitalization” if the event necessitated an admission to a healthcare facility (eg, overnight stay). Events that require an escalation of care when the subject is already hospitalized should be recorded as an SAE. Examples of such events include movement from routine care in the hospital to the intensive care unit (ICU) or if that event resulted in a prolongation of the existing planned hospitalization. If an investigator considers an event to be clinically important, but it does not meet any of the serious criteria, the event could be classified as an SAE with the criterion of “other medically important serious event.” The terms “severe” and “serious” are not synonymous. Severity refers to the intensity of an adverse event according to NCI CTCAE criteria; the event itself may be of relatively minor medical significance and, therefore, may not meet the seriousness criteria. Severity (ie, grade) and seriousness need to be independently assessed for each adverse event recorded on the eCRF.