9.1. Adverse Events A dverse event terms recorded on the eCRFs will be coded to PTs using version 11.0 or later of the M edical Dictionary for Regulatory A ctivities (MedDRA) . Toxicity grade will be defined according to the version 4.0 or later of the National Cancer Institute (NCI ) Common Terminology Criteria for Adverse Events (CTCAE ). A treatment emergent adverse event (TEAE) is defined as any AE with an onset date on or af ter date of first dose of study product, or any ongoing event on the date of first dose that increases in CTCAE grade after date of first dose. Only TEAEs with an onset date before date of last dose + 28 days will be tabulated in summary tables. Adverse events that begin prior to first dose will be captured in the medical history. Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential 19 Revised: June 2015 F urthermore each TEAE will be classified based on the period in which it started. Primary period TEAEs will be defined as TEAEs with onset date on or after the date of the first dose of study product and before the date of the second dose of study product. Booster period TEAEs will be defined as TEAEs with onset date on or after the date of the second dose of study product. F or the purpose of calculating treatment emergence, period, and inclusion in summary tables, incomplete onset dates will be imputed as detailed in Appendix C of this document. 9.1.1. Incidence of Adverse Events T he frequency and percentage of subjects with TE AEs wil l be tabulated for overall incidence by system organ class (SOC) and PT for primary period TEAEs, booster period TEAEs and overall. T EAEs will also be summarized by treatment arm and overall for the highest CTCAE grade and highest relationship to study treatment within each subject. Related TEAEs, serious TEAEs, related serious TEAEs, and TEAEs resulting in study product discontinuation will be similarly summarized. Additionally, the incidence of TEAEs and related TEAEs will be summarized by PT in desc ending order of total frequency. The incidence of TEAEs coded as injection site reactions will be summarized by type of injection (primary or booster) and by arm. A t each level of summarization, a subject will be counted only once for each AE he/she expe riences within that level. Data l isting s of all AEs and SAEs will be provided. Adverse events presented in the listings will be those recorded from the first dose date through the end of follow-up. 9.1.2. Survival Status and Death S ubject survival status will be summarized in a table using the FAS. Furthermore, all subject deaths during this study will be presented in a listing. The listing will provide all relevant eCRF data pertaining to each subject death.