definiens: shall mean, with respect to the Produ ct, any serious adverse event occurring during clin ical trials of the drug at any dose that results in any of the following outcomes : death, a life - threatening adver se drug experience, inpatient hospitalization or prolongati on of existing hospitalization, a persistent or sig nificant disability / incapacity, or a congenital anomaly / birt h defect . Important medical events that may not res ult in death, be life - threatening or require hospitalization may be considered a serious adverse drug experience whe n, based upon appropriate medical judgment, they may jeopard ize the patient or subject and may require medical or surgical intervention to prevent one of the outcome s listed in this definition . Examples of such medic al events include allergic bronchospasm requiring intensive t reatment in an emergency room or at home, blood dys crasias or convulsions that do not result in patient hospit alization, or the development of drug dependency or drug abuse