Any adverse experience associated with the study article that results in any of the following outcomes: death, a life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Any adverse event (AE) that is fatal, life-threatening, or permanently disabling, or that results in new or prolonged hospitalization
A SAE is defined as death; a life threatening experience; hospitalization (for a person not already hospitalized); prolongation of hospitalization (for a patient already hospitalized); persistent or significant disability or incapacity; congenital anomaly and/or birth defects; or an event that jeopardizes the subject and may require medical or surgical treatment to prevent one of the preceding outcomes.
Any adverse event (AE) that is fatal, life-threatening, permanently disabling, or which results in hospitalization, initial or prolonged.
or serious adverse drug reaction (serious ADR) Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (ICH)
A serious adverse event (SAE) is a reaction to a treatment that results in death, a life-threatening situation, a need for admittance to a hospital, or having to stay in a hospital longer than if the treatment had not been administered. It also refers to a temporary or permanent disability or a birth defect in a study participant's child.