If a subject terminates participation in the study and does not return for the Visit 16 assessments, their last recorded assessments shall remain recorded with their last visit. The reason for discontinuation will be recorded, and the data collected up to the time of discontinuation will be used in the analysis and included in the clinical study report. If additional assessments are required, the assessments shall be recorded separately. In the event of subject discontinuation due to an AE, clinical and/or laboratory investigations that are beyond the scope of the required study observations/assessments may be performed as part of the evaluation of the event. These investigations will take place under the direction of the investigator in consultation with the sponsor, and the details of the outcome may be reported to the appropriate regulatory authoritie s by the sponsor. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 58 of 81 CONFIDENTIAL 8 ADVERSE EVENTS AND SERIOUS ADVERSE EVENT S Timely collection and assessment of SAE reports are critical for protecting the safety of patients. SAE reporting is a regulatory responsibility of the Sponsor under the Code of Federal Regulations (Title 21, Sub-Part B, section 312.32). 8.1 Definitions 8.1.1 Adverse Event An AE is defined as any untoward medical occurrence in a subject administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether considered causally related to the I P. A treatment -emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. 8.1.2 Serious Adverse Event An SAE is defined as an untoward medical occurrence that at any dose meets 1 or more of the following criteria: 1. Outcome is fatal/results in death (including fetal death) .