serious adverse drug experience
(4) Serious adverse drug experience The term “serious adverse drug experience” is an adverse drug experience that— (A) results in— (i) death; (ii) an adverse drug experience that places the patient at immediate risk of death from the adverse drug experience as it occurred (not including an adverse drug experience that might have caused death had it occurred in a more severe form); (iii) inpatient hospitalization or prolongation of existing hospitalization; (iv) a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or (v) a congenital anomaly or birth defect; or (B) based on appropriate medical judgment, may jeopardize the patient and may require a medical or surgical intervention to prevent an outcome described under subparagraph (A).