• . 8.2 A SSESSMENT OF SAFETY EVENTS AE information collected will include event description, date of onset, assessment of severity and relationship to study product and alternate etiology (if not related to study product) , date of resolution of the event, seriousness and outcome. The assessment of severity and relationship to the study product will be done only by those with the training and authority to make a diagnosis and listed on the Form FDA 1572 as the site principal investigator or sub- investigator. AEs occurring during the collection and reporting period will be documented appropriately regardless of relationship. AEs will be followed through resolution. SAEs will be: 72 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 • Assessed for severity and relationship to study product and alternate etiology (if not related to study product) by a licensed study physician listed on the Form FDA 1572 as the site principal investigator or sub-investigator. • Recorded on the appropriate SAE report form , the medical record and captured in the clinical database.