9.3. ADVERSE EVENTS An adverse event (AE) is defined as any untoward medical occurrence in a patient enrolled in this study regardless of its causal relationship to study treatment. Disease progression in the medical opinion of the physician and/or disease-related morbidity and mortality as a study endpoint will not be considered an AE or serious adverse event (SAE). An SAE is defined as any event that  Results in death  Is immediately life threatening DocuSign Envelope ID: B3F56764-C440-4885-BA44-7578C4A73DB3 Stemline Therapeutics, Inc. Protocol: STML- 701-0114 Version 3.0, 10-JUL-2015 (Amendment 2) Statistical Analysis Plan Page 37 of 63  Requires inpatient hospitalization or prolongation of existing hospitalization  Results in persistent or significant disability/incapacity  Is a congenital anomaly/birth defect A treatment-emergent adverse event (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. If an adverse event start date is partially or completely missing, then the following rules will be used to impute the start date for the purposes of determining treatment emergence only.