Clin. Oncol.: Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T., Carbone, P.P.: Toxicity And Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649- 655, 1982. The ECOG Performance Status is in the public domain therefore available for public use. To duplicate the scale, please cite the reference above and credit the Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair. Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 85 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.5 NYHA Classification – The Stages of Heart Failure In order to determine the best course of therapy, physicians often assess the stage of heart failure according to the New York Heart Association (NYHA) functional classification system. This system relates symptoms to everyday activities and the patient's quality of life. Class Patient Symptoms Class I (Mild) No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild) Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III (Moderate) Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe) Unable to carry out any phy sical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 86 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.6 NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v 4.0) A copy of the CTCAE version 4.0 can be downloaded from the CTEP website at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. A hard copy of the CTCAE version 4.0 can be found in the Study Instruction Manual. Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 87 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.7 FACT -P Quality of Life Questionnaire Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 88 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 89 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 90 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.8 BPI-SF Quality of Life Questionnaire Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 91 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 92 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.9 EQ-5D-3L Quality of Life Questionnaire Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 93 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. Protocol BNIT -PRV - 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 94 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.10 Vial and Carton Labels Labels are provided as reference only and are provided as examples. Specific label text and language may vary depending on country. Labeling for Phase III PROSTVAC -V Outer carton label (Vaccinia) Labeling for Phase III PROSTVAC -V and placebo vials: Vial label: (All vial numbers shown are for demonstration purposes only) Protocol BNIT -PRV - 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 95 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. Labeling for Phase III PROSTVAC -F Outer carton label (Fowlpox) Labeling for Phase III PROSTVAC -F and placebo vials: Vial label: (All vial numbers shown are for demonstration purposes only) Protocol BNIT -PRV - 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 96 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. Labeling for Phase III GM - CSF Outer carton label Bacteriostatic 0.9% Sodium Chloride for Injection, USP, Secondary Package Label (for tray containing 25 vials, booklet label text) Protocol BNIT -PRV - 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 97 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc.