Patients should be monitored for AEs consistent with the current Investigator’s Brochure for PolyPEPI 1018. 6.7.2 Urgent Safety Measures An urgent safety measure is an immediate action taken, which is not defined by the protocol, to protect subjects participating in a clinical trial from immediate harm. Urgent safety measures may be taken by the by the investigator or the safety review team , and may include any of the following: 1. Immediate change in study design or study procedures 2. Temporary or permanent halt of a given clinical trial or trials 3. Any other immediate action taken to protect clinical trial participants from immediate hazard to their health and safety The investigator or the safety review team may take appropriate urgent safety measures to protect subjects against any immediate hazard to their health or safety. The measures sho uld be taken immediately and may be taken without prior authorization from the sponsor. In the event(s) of an apparent immediate hazard to the subje ct, the investigator will notify the medical monitor immediately by phone and confirm notification to the safety review team in writing as soon as possible, but within 1 calendar day after the change is implemented. The sponsor will also ensure the respons ible ethics committee(s) and relevant competent authority(s) are notified of the urgent safety measures taken in such cases according to local regulations. 6.7.3 Untoward Medical Occurrences Untoward medical occurrences occurring before the first exposure to IP are not considered AEs (according to the definition of AE, see Section 8). However, each serious untoward medical occurrence experienced before the IP exposure (i.e., from the time of signed Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 51 of 81 CONFIDENTIAL informed consent up to but not including the IP exposure) will be described on the AE CRF and on the SAE Report Form. These events will not be considered as SAEs and will not be included in the analysis of SAEs. For the purposes of this study, each non- serious untoward medical occurrence experienced by a subject undergoing study- related procedure(s) before the IP exposure will be recorded on the AE CRF; these events will not be considered as AEs and will not be included in the analysis of AEs. 6.7.4 Non-Medical Complaints A non-medical complaint (NMC) is any alleged product deficiency that relates to identity, quality, durability, reliability, safety, and performance of the product but did not result in an AE. NMCs incl ude but are not limited to the following: 1. A failure of a product to exhibit its expected pharmacological activity and/or design function, e.g. reconstitution difficulty 2. Missing components 3. Damage to the product or unit carton 4. A mislabeled product (e.g., potential counterfeiting/tampering) 5. A bacteriological, chemical, or physical change or deterioration of the product causing it to malfunction or to present a hazard or fail to meet label claims Any NMCs of the product will be documented on an NMC form and reported to the sponsor within 1 business day. If requested, defective product(s) will be returned to the sponsor for inspection and analysis according to procedures. 6.7.5 Medical, Medication, and Non -Drug Therapy History At Screening, the subject’s medical his tory will be described for the following body systems including severity (defined in Section 8.2.1) or surgery and start and end dates, if known: eyes, ears, nose, and throat; respiratory; cardiovascular; gastrointestinal; musculoskeletal; neurological; endocrine; hematopoietic/lymphatic; dermatological; and genitourinary. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 52 of 81 CONFIDENTIAL All medications taken and non-drug therapies received from 3 months prior to enrollment until completion/termination will be rec orded on the concomitant medications and non- drug therapies CRFs. 6.7.6 Physical Examinations Complete and targeted physical examinations will be performed as summarized in Appendix A .