Definition of Serious Adverse Events. A SAE is defined as an AE 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 ⎯ 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. • Results in persistent or significant disability/incapacity • Congenital anomaly/birth defect • Other medically important serious event ⎯ 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 and seriousness need to be independently assessed for each adverse event recorded on the CRF. • Progression of the malignancy during the study should not be reported as a AE. However, signs and sympotms of disease progression may be recorded as AEs or SAEs and indicated as being due to disease progression in the CRF. If the malignancy has a fatal outcome before the end of the SAE reporting period, the the event leading to the death must be recorded as an SAE with the outcome of being fatal.
Definition of Serious Adverse Events. A serious adverse event (SAE) is defined as an AE that meets at least one of the following serious criteria: • Results in death; • Is life-threatening; • Requires in-participant hospitalization or prolongation of existing hospitalization; • Results in persistent or significant disability / incapacity; • Is a congenital anomaly / birth defect; • Is an important medical event. Death is an outcome of a SAE, and not a SAE in itself. All deaths must be reported for participants on study and for deaths occurring within 30 days of last study drug(s) administration or within 30 days of last study evaluation, whichever is longer, to ensure immediate reporting to all appropriate regulatory bodies within the required timelines as applicable. The Investigator should provide any additional requested information as available (e.g. autopsy reports and terminal medical reports). The term “life-threatening” in the definition of “serious” refers to an event in which the participant was at immediate risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more serious. Hospitalization is defined as the participant being hospitalized overnight, or the participant’s hospital stay being prolonged for at least an additional overnight stay. Hospital admissions for a pre-existing condition or for normal disease management procedures (e.g. chemotherapy) will not be considered a SAE. Complications that occur during hospitalizations, prolonging hospitalization by ≥ 24 hrs are an SAE. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be SAEs when, based upon appropriate medical judgment, they may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias, or convulsions, or the development of drug dependency or drug abuse.
