A listing of deaths including the patient number, site, treatment group, date and study day of death, and cause of death will be provided. 8.4 Clinical Laboratory Evaluations Hematology Results The hematology values to be measured include hemoglobin, hematocrit, platelet counts, red blood cell (RBC) count, lymphocyte count, neutrophil count, and white blood cell (WBC) count. Where applicable, Laboratory results for hemoglobin, platelet count, lymphocyte counts, neutrophil counts, and WBC counts will be classified according to the NCI CTCAE version 4.03, and shift tables of baseline grades vs worst post-baseline grades for these parameters will be presented. For other parameters, shift tables of low/normal/high at baseline vs post-baseline may be presented where appropriate. Laboratory values and change from baseline for selected parameters may also be summarised by visit. Serum Chemistry Results The serum chemistry values to be measured include sodium, calcium, total protein, albumin, creatinine, blood urea nitrogen, total bilirubin, alkaline phosphatase, AST, ALT, potassium, chloride, bicarbonate, lactate dehydrogenase, and glucose. Where applicable, laboratory results will be classified according to the NCI CTCAE version 4.03, and shift tables of baseline grades vs worst post-baseline grades for these parameters will be presented. For other parameters, shift tables of low/normal/high at baseline vs post-baseline may be presented where appropriate. Laboratory values and change from baseline for selected parameters may also be summarised by visit. Heat Biologics, Inc. Protocol HS410-101 HS410-101 SAP version 1.0 Page 23 of 25 8.5 Other Safety Measures Urinalysis Patients will have urine samples collected for routine urinalysis. The urinalysis will include colour, appearance, and dipstick for specific gravity, protein, white blood cell-esterase, glucose, ketones, urobilinogen, nitrite, WBC, RBC, and pH. Shift table of baseline vs post-baseline, or summary statistics of actual values and change from baseline values at each visit, will be presented accordingly. ECG The following parameters from 12-lead electrocardiograms will be evaluated: heart rate, PR interval, QRS duration, QT interval, and QTcF interval. Descriptive statistics for these parameters will be summarised at baseline. The values and change from baseline will be summarised at weeks 7, 14 and 29 in phase I, and at week 56 for phase II. The following changes will be flagged in listings:  Absolute QTc interval prolongation: - QTc interval > 450 - QTc interval > 480 - QTc interval > 500  Change from baseline in QTc interval: - QTc interval increases from baseline >30 - QTc interval increases from baseline >60 Injection Site Reactions Injection site reactions will be summarized by the type of reaction (Pain, erythema, edema, pruritus, warmth, hematoma, induration, other) and by grade. Incidence of injection site reactions leading to dose interruption and to drug discontinuation will be summarized, where appropriate. Time to first onset of injection site reaction (i.e. the number of vesigenurtacel administered by the onset of the first injection site reaction) will be calculated using Kaplan-Meier methodology. Number of patients with more than one injection site reactions will also be presented. Vital Signs Vital sign measurements collected include blood pressure, heart rate, respirations, and body temperature. Body temperature will be collected in °F or °C, but reported in °C. Data will be converted to °C for summarization purposes using the following formula: °C = 5/9 (°F-32). Vital signs and change from baseline in vital signs will be summarized by descriptive statistics (n, mean, standard deviation, median, minimum, and maximum) at each scheduled visit. Appendix 1: List of Planned Figures and Tables Heat Biologics, Inc. Protocol HS410-101 HS410-101 SAP version 1.0 Page 24 of 25 Heat Biologics, Inc. Protocol HS410-101 HS410-101 SAP version 1.0 Page 25 of 25 9 References 1. American Cancer Society.