definiens: means any adverse drug experience occurring at any dose that results in any of the following outcomes : death, a life - threatening adverse drug experience, inpatient hosp italization or prolongation of existing hospitaliza tion, a persistent or significant disability / incapacity, or a congenital anomaly / birth defect . Important medic al events that may not result in death, be life - threat ening, or require hospitalization may be considered a Serious Adverse Drug Experience when, based upon ap propriate medical judgment, they may jeopardize the patient or subject and may require medical or s urgical intervention to prevent one of the outcomes listed in this definition as more fully defined in Section 19 [ Note : Certain portions of this document have been marked or to indicate that confidentiality has been requested fo r this confidential information . The portions have been omitted and filed separately with the Securities an d Exchange Commission . ] 314.80 ( or Section 600.80, as applicable ) of Title 21 of the U.S. Code of Federal Regulations in the U .S