Seriousness as defined in Section 8.1.2 2. Severity as defined in Section 8.2.1 3. Causal relationship to IP exposure or study procedure as defined in Section 8.2.2 For each AE, the outcome (i.e., recovering/resolving, recovered/resolved, recovered/resolved with sequelae, not recovered/not resolved, fatal, unknown) and if applicable (e.g. for maintenance therapy drugs) action taken (i.e., dose increased, dose not changed, dose reduced, drug interrupted, drug withdrawn, not applicable, or unknown) will also be recorded on the AE CRF. AEs attribution must be clearly specified, whether it is attributed to the vaccine or to maintenance drugs or any other concomitant medication. Recovering/resolving AEs will be followed until resolution, medically stabilized, or 30 days after the study completion, whichever comes first). If the severity rating for an ongoing AE changes before the event resolves, the original AE report will be revised (i.e., the event will not be reported as separate AE). During the course of any AE, the highest severity rating will be reported. Deviations from the protocol-specified dosage (including overdosing, under dosing, abuse, and withdrawal), treatment errors (including incorrect route of administration, use of an incorrect product, and deviations from the protocol-defined dosing schedule), failures of expected pharmacological actions, and unexpected therapeutic or clinical benefits will be followed with regard to occurrence of AEs, lack of efficacy, and/or other observations because these events may be reportable to regulatory authorities. Any pregnancy that occurs after administration of IP to a female subject or to a male subject whose partner gets pregnant during the study period will be reported on a Pregnancy Re port Form and followed- up at estimated date of delivery. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 61 of 81 CONFIDENTIAL If an investigator becomes aware of an SAE occurring in a subject after study completion, the SAE must be reported on the provided SAE Report Form within 24 hours after awareness; no additional reporting on CRFs is necessary. 8.2.1 Severity The safety review team will assess the severity of each AE using his/her clinical expertise and judgment based on the most appropriate description below (according to CTCAE Version 4.0): 1.