The Regulatory Affairs Officer will then report the event to the Sponsor/Investigator. The IND Sponsor/Investigator or Sponsor/Investigator’s representative will report these to the FDA and Galena Biopharma. Serious criteria, definitions, and guidance for reporting follow. An adverse event (AE) is any untoward medical occurrence in a patient participating in an investigational study or protocol regardless of causality 37 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 assessment. An adverse event can be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, syndrome or disease associated with or occurring during the use of an investigational product whether or not considered related to the investigational product. Serious adverse events (SAE) are AEs occurring at any dose which meet one or more of the following serious criteria: • Results in death (i.e. the AE caused or led to death) • Is life-threatening (i.e. the AE placed the patient at immediate risk of death; it does not apply to an AE which hypothetically might have caused the death if it were more severe) • Requires or prolongs inpatient hospitalization (i.e. the patient was admitted to the hospital or extended hospitalization due to the event) • Is disabling (i.e. the AE resulted in a substantial disruption of the patient’s ability to carry out normal life functions) • Results in a congenital anomaly/birth defect (i.e., an adverse outcome in a child or fetus of a patient exposed to the study drug prior to conception or during pregnancy) • Does not meet any of the above serious criteria but may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed above Expected AEs are those AEs that are listed or characterized in the current Investigator Brochure. Unexpected AEs are those not listed in the current Investigator Brochure.