definiens: means the trademark [COMPANY] ®, the [COMPANY] corporate logo and any other related trademark or service mark ( whether registered or unregistered ) containing the word 1.21 shall mean any adverse drug experience occurring at any dose that results in any ofthe following outcomes : death, a life - threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, or a congenital anomaly / birth defect . Important medical events that may not result in death, be life - threatening, or require hospitalization may be considered a Serious Adverse Event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition . Examples of such medical events include allergic bronchospasm requiring intensive treatment in an 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 associated with the use of the Product in humans, whether or not considered drug - related