(1) results in death;
(2) is life-threatening (places the subject at immediate risk of death
from the event as it occurred);
(3) results in inpatient hospitalization or prolongation of existing
hospitalization;
(4) results in a persistent or significant disability/incapacity;
(5) results in a congenital anomaly/birth defect; or
(6) based upon appropriate medical judgment, may jeopardize the subject's
health and may require medical or surgical intervention to prevent one
of the other outcomes listed in this definition (examples of such events
include allergic bronchospasm requiring intensive treatment in the emergency
room or at home, blood dyscrasias or convulsions that do not result
in inpatient hospitalization, or the development of drug dependency
or drug abuse).
(Modified from the definition of serious adverse drug experience in
FDA regulations at 21 CFR 312.32(a).)