96 7.2.1. Serum for Assessment of Tremelimumab Pharmacokinetics ..................... 96 PF-06936308 C3621001Final Protocol Amendment 2, 22 Dec 2020 PFIZER CONFIDENTIAL Page 97.2.2. Serum for Assessment of Sasanlimab Pharmacokinetics ...........................97 7.4. Tumor Response Assessments ..............................................................................100 7.5. Tremelimumab and Sasanlimab Immunogenicity Assessments ...........................101 7.7. Other Assessments ................................................................................................103 7.7.1. Tumor and Medical History......................................................................103 8. ADVERSE EVENT REPORTING....................................................................................103 8.1. Requirements.........................................................................................................103 8.1.1. Additional Details On Recording Adverse Events on the CRF................1058.1.2. Eliciting Adverse Event Information........................................................1058.1.3. Withdrawal From the Study Due to Adverse Events (see also the Participant Withdrawal Section)....................................................................105 8.1.4. Time Period for Collecting AE/SAE Information....................................105 8.1.4.1. Reporting SAEs to Pfizer Safety.............................................1058.1.4.2. Recording Non-serious AEs and SAEs on the CRF ...............106 8.1.5. Causality Assessment ...............................................................................1068.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities ................106 8.2. Definitions.............................................................................................................10 7 8.2.1. Adverse Events .........................................................................................1078.2.2. Abnormal Test Findings ...........................................................................1088.2.3. Serious Adverse Events ............................................................................1088.2.4. Hospitalization..........................................................................................109 8.3. Severity Assessment..............................................................................................1118.4.