6.2. Medical History 6.2.1. General Medical History Med ical history will be presented as a data listing. 6.2.2. Prostate Cancer History P rostate cancer history and curative intent treatment for prostate cancer will be summarized by treatment arm and overall for the FAS. Y ears since initial diagnosis, Gleason sum at initial diagnosis and days since recurrence after curative intent treatment will be summarized using descriptive statistics. TNM status at initial diagnosis will be summarized using frequency counts and percentages. Bavarian Nordic, Inc. Statistical Analysis Plan Amendment 1 Protocol: BNIT -PRV -301 Date Issued: 29 June 2015 C onfidential 10 Revised: June 2015 Years since initial diagnosis is d efined as the integer part of (date of first dose – date of initial diagnosis + 1)/365.25. D ays since recurrence after curative intent treatment is defined as date of first dose – date of f irst increased PSA value since curative intent treatment + 1. I ncomplete dates will be imputed as follows: •If day is missing, then the day will be set to the 15th of the month.