definiens: means any adverse drug experience occurring 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 a congenital anomalylbirth defect . Important medical events that may not result in death, be life - threatening, or require hospitalization may be considered a Serious Adverse Drug Experience 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 as more fully defined in Section 314.80 ( or Section 600.80, as applicable ) of Title 21 of the U.S. Code of Federal Regulations in the U.S. means any unfavorable and unintended sign ( including an abnormal laboratory finding, for example ), symptom or disease associated with the use of Elestat, whether or not considered drug related . This includes without limitation the following : drug overdose whether accidental or intentional, drug abuse, drug withdrawal, or any failure of expected pharmacological action . includes without limitation the following : cancellation of import approval, discontinuation of marketing, recall order from the market, destruction order, instructions to revise or and any other information which influences the labeling or safety use of Elestat