definiens: means, any adverse drug event occurring at any dose that results in any of the following outcomes : Dea th, a life - threatening adverse drug event, inpatient hospitali zation or prolongation of existing hospitalization, a persistent or significant disability / incapacity, or a congenit al anomaly / birth defect . Important medical events t hat may not result in death, be life - threatening, or require ho spitalization may be considered a serious adverse d rug event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may requ ire medical or surgical intervention to prevent one of the outcomes listed in this definition . Examples of such medical events include allergic bronchospasm requir ing 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 . means, any adverse drug event that is not listed in the cu rrent labeling for the Product . This includes events that may be symptomatically and pathophysiologically re lated to an event listed in the labelling, but differ 14 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT O F A CONFIDENTIAL TREATMENT REQUEST . REDACTED MATERIAL IS MARKED WITH [ * * * ] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE C OMMISSION