Statistical methods
MIN
ADENOVIRUS, ADVERSE EVENT
Adverse events, graded using CTCAE v4.03, were collected through day 30 (day 1 being the day of the adenovirus injection). The effect of oncolytic adenovirus-mediated cytotoxic and IL-12 gene therapy on serum PSA levels was evaluated by estimating PSA doubling time (PSADT). PSADT was estimated for each patient pre-injection and post-injection. A single model of log (PSA) on time was built for each patient, and the PSA doubling time was calculated for each patient for pre-injection PSADT. For post-injection PSADT estimation, PSA doubling time from nadir was estimated using all PSA values. Minimum (MIN), Median and Mean values were estimated for pre- and post- injection PSADT. Additionally, post-injected PSADT for cohorts 1–3 and 4–5 were pooled.PSADT was calculated assuming first-order kinetics using the following equation:
