2. Unlikely related (either 1 or both circumstances are met) o Has little or no temporal relationsh ip to the IP o A more likely alternative etiology exists 3. Possibly related (both circumstances must be met) o Follows a reasonable temporal relationship to the administration of IP o An alternative etiology is equally or less likely compared to the potential relationship to the IP 4. Probably related (both circumstances must be met) o Follows a strong temporal relationship to the administration of IP, which may include but is not limited to the following: – Reappearance of a similar reaction upon re-administration (pos itive rechallenge) – Positive results in a drug sensitivity test (skin test, etc.) – Toxic level of the IP as evidenced by measurement of the IP concentrations in the blood or other bodily fluid o Another etiology is unlikely or significantly less likely 5. Definitely related o There is clear evidence to suggest a causal relationship and other possible contributing factors can be ruled out. These causality definitions will also be used to assess the rel ationship of an AE with a study-related procedure(s), if necessary . Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 63 of 81 CONFIDENTIAL 9 STATISTICS 9.1 Analysis Populations The Safety Analysis Set (SAS) will include all subjects who receive at least 1 dose of the IP . This population will be the primary analysis set for safety outcomes.