Tertiary Objectives ............................................................................................................. 16 8.5.1. HLA-A2 Status ....................................................................................................... 17 8.5.2. Absence of Progression at 12 Months .................................................................... 17 8.5.3. Post-Progression Anti- Cancer Therapies ................................................................ 17 8.5.4. Immune Responses ................................................................................................. 18 8.5.5. Circulating Tumor Cells ......................................................................................... 18 8.5.6. Tumor Regression and Growth Rate....................................................................... 18 8.5.7. Overall Prognostic Model ....................................................................................... 18 9. Safety Analysis ................................ ..................................................................................... 18 9.1. Adverse Events .................................................................................................................. 18 9.1.1. Incidence of Adverse Events .................................................................................. 19 9.1.2. Survival Status and Death ....................................................................................... 19 9.2. Clinical Laboratory Evaluations ........................................................................................ 19 9.3. Cardiac Markers ................................................................................................................. 20 9.4. Vital Sign Measurements ................................................................................................... 20 9.5. Physical Examination......................................................................................................... 20 9.6. Electrocardiogram .............................................................................................................. 20 Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential iv Revised: June 2015 9.7. Immune Monitoring ...........................................................................................................