Serious Adverse Event

Extract

According to NIH’s Office of Biotechnology Activities, the definition of a serious adverse event follows the same guidelines as the definition of a serious adverse drug experience, which is given in Title 21 of the Code of Federal Regulations, Vol. 5, Sec. 312.32:

“Serious adverse drug experience: Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug 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 drug experience 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.”