14.2 NIH RAC Appendix B (excerpt) Appendix B - Table 1. Basis for the Classification of Biohazardous Agents by Risk Group (RG) Risk Group 1 (RG1) Agents that are not associated with disease in healthy adult humans Risk Group 2 (RG2) Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available Risk Group 3 (RG3) Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk) Risk Group 4 (RG4) Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk) Appendix B -I. Risk Group 1 (RG1) Agents RG1 agents are not associated with disease in healthy adult humans. Appendix B -II. Risk Group 2 (RG2) Agents RG2 agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available. Those agents not listed in Risk Groups (RGs) 3 and 4 are not automatically or implicitly classified in RG1 or 2; a risk assessment must be conducted based on the known and potential properties of the agents and their relationship to agents that are listed. Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 83 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.3 Criteria of Progression for Trial Eligibili ty by PCWG2 (2007) Variable PCWG2 (2007) PSA Obtain sequence of rising values at a minimum of 1 -week intervals 2.0 ng/mL minimum starting value Estimate pretherapy PSA -DT if 3 or more values available 4 or more weeks apart Scher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for patient with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J clin Oncol 2008;26:1148- 59. Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 84 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.4 ECOG Performance Status Criteria These scales and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. They are included here for health care professionals to access. ECOG PERFORMANCE STATUS* Grade ECOG 0 Fully active, able to carry on all pre -disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3 Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5 Dead * As published in Am. J.