Is a medically important event – a medical event that may not be immediately life-threatening or result in death or require hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the definitions above. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 59 of 81 CONFIDENTIAL 8.1.3 Suspected Unexpected Serious Adverse Reaction (SUSAR) Any suspected adverse reaction to study treatment (i.e., including active comparators) that is both serious and unexpected. The event(s) must meet all the following: • Suspected adverse reaction • Serious • Unexpected • Assessed as related to study treatment Once determined to meet the criteria for a SUSAR, an SAE should be submitted to regulatory agencies expeditiously. 8.1.4 Non-Serious Adverse Event A non-serious AE is an AE that does not meet the criteria of an SAE. 8.1.5 Unexpected Adverse Events An unexpected adverse event is an AE whose nature, severity, specificity, or outcome is not consistent with the term, representation, or description used in the Reference Safety Information (RSI). “Unexpected” also refers to the AEs that are mentioned in the Investigator’s Brochure as occurring with a class of drugs or as anticipated from the pharmacological properties of the product, but are not specifically mentioned as occurring with the product under investigation. The expectednes s of AEs will be determined by the sponsor using the Investigator’s Brochure as the RSI. This determination will include considerations such as the number of AEs previously observed, but not on the basis of what might be anticipated form the pharmacologica l properties of a product. 8.1.6 Preexisting Diseases Preexisting diseases that are present before entry in to the study are described in the medical history, and those that manifest with the same severity, frequency, or duration after IP exposure, will not be recorded as AEs. However, when there is an increase in the severity, duration, or frequency of a preexisting disease, the event must be described on the AE CRF. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 60 of 81 CONFIDENTIAL 8.2 Assessment of Adverse Events Each AE from the IP exposure until study completion/discontinuation date will be described on the AE CRF using the medical diagnosis (preferred), or, if no diagnosis could be established at the time of reporting the AE, a symptom or sign, in standard medic al terminology to avoid the use of vague, ambiguous, or colloquial expressions (see definition in Section 8.1). Each AE will be evaluated by the safety review team for: 1.