definiens: shall mean, with respect to the Product, any serious adverse event occurring during clinical trials of thedrug 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 acongenital anomaly / birth defect . Important medical events that may not result in death, be life - threatening or requirehospitalization may be considered a serious adverse drug experience when, based upon appropriate medicaljudgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent oneof the outcomes listed in this definition . Examples of such medical events include allergic bronchospasm requiringintensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in patienthospitalization, or the development of drug dependency or drug abuse