Mild (Grade 1) o Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated 2. Moderate (Grade 2) o Minimal, local or noninvasive intervention indicated; limiting age -appropriate instrumental activities of daily living (ADL) 3. Severe (Grade 3) o Severe or medically significant but not immediately life -threatening; hospitalization or prolongation of hospitalization indi cated; disabling; limiting self-care ADL 4. Life threatening (Grade 4) o Life-threatening consequences; urgent intervention indicated 5. Death related to AE (Grade 5) o Grade 5 is not appropriate for some AEs and therefore is not an option These severity definitions will also be used to assess the severity of an AE with a study-related procedure(s), if necessary. 8.2.2 Causality Causality is a determination of whether there is a reasonable possibility that the IP is etiologically related to/associated with the AE. Causality assessment includes, e .g., assessment of temporal relationships, dechallenge/rechallenge information, association (or lack of association) with underlying disease, presence (or absence) of a more likely cause, and physiological plausibility. For each AE, the safety review team will assess the causal Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 62 of 81 CONFIDENTIAL relationship between the IP and the AE using his/her clinical expertise and ju dgment according to the following most appropriate algorithm for the circumstances of the AE: 1. Not related (both circumstances must be met) o Is due to underlying or concurrent illness, complications, concurrent treatments, or effects of concurrent drugs o Is not associated with the IP (i.e., does not follow a reasonable temporal relationship to the administration of IP or has a much more likely alternative etiology).