Unless otherwise noted, safety variables will be tabulated by descriptive statistics (n, mean, median, SD, minimum, and maximum; or n and percent) using the Safety Population. When calculating the incidence of adverse events, or any sub-classification thereof by treatment, time period, severity, etc., each subject will only be counted once and any repetitions will be ignored; the denominator will be the total population (or treatment group, as applicable) size. A descriptive summary of all Treatment emergent adverse events (TEAEs) by system organ class and preferred term will be provided. 8.1 Extent of Exposure Treatment exposure will be summarized by treatment group, in the following ways: (1) Number of doses of vesigenurtacel in phase I and vesigenurtacel/placebo in each arm in phase II, overall and also separately for induction phase and for maintenance phase. (2) Cumulative doses of vesigenurtacel in phase I and vesigenurtacel/placebo in each arm in phase II, overall and also separately for induction phase and for maintenance phase. (3) Cumulative BCG dose in arms 1,2,3 in phase II, overall and also separately for induction phase and for maintenance phase. (4) Number of patients receiving the full dose vs partial dose of vesigenurtacel and BCG in induction and maintenance up to 12 months since the start of induction of BCG. The number of patients receiving additional maintenance (as per physician’s choice) beyond 12 months from the start of induction of BCG will also be summarised. (5) Number of dose reductions / dose delays in vesigenurtacel and BCG 8.2 Adverse Events Heat Biologics, Inc. Protocol HS410-101 HS410-101 SAP version 1.0 Page 22 of 25 TEAEs will be defined as events that occur on or after the first dose of study medication. The Medical Dictionary for Regulatory Activities (MedDRA) coding dictionary will be used for the coding of AEs (version 18.0 or higher). The severity of TEAEs will be graded on a scale of 1 to 5 according to the adult NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0) where higher grades indicate events of higher severity. Adverse events will be summarized by grade according to the worst grade experienced. TEAEs, serious or CTCAE grades -5 TEAEs, and TEAEs related to therapy will be summarized overall and by system organ class and preferred term by treatment group. A listing of AEs leading to treatment discontinuation including the patient number, site, treatment group, start date and study day of AE, severity, relationship to study regimen, action taken, and outcome of AE will be provided. Additional summary table summarizing preferred term may be provided if warranted. For summary purposes, AEs will be defined as all reported events with a start date on or after Study Day 1. All AEs are collected through 30 days post last dose (treatment-emergent AEs). All AEs will have their relationship to study drug (BCG or HS-410) assessed by the investigator as related or not related. Adverse events will be categorized and summarized according to their highest relationship to study drug. 8.3 Serious Adverse Events, Premature Treatment Discontinuation and Deaths A listing of SAEs including the patient number, site, treatment group, start date and study day of SAE, severity, relationship to study drug, action taken, and outcome of SAE will be provided. Additional summary table by preferred term may be provided if warranted.