Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 17 of 27 • Abnormal laboratory values with their clinical significance status will be presented in a listing. • Urinalysis data, differentials (%), and RDW will be presented in listings only • Magnesium, MCV, MCH, MCHC, MPV, differentials (absolute count), aPTT, PT, and INR will be presented in listings and summary tables but NOT in shift tables. • The remaining analytes will be presented i n listings, summary tables and shift tables The following summaries will be presented: • Overall values by time point utilizing continuous descriptive statistics for each arm and cohort. • For categorical parameters, the n and percentage will be displayed for each arm and cohort. • Frequencies and percentages for the shifts in these categories (i.e., low to normal, low to high, high to low, etc.) from baseline to each post- treatment assessment time point. For each continuous laboratory parameter, r esults will be categorized as low, normal, or high based on the laboratory normal ranges. Frequencies and percentages will be presented by Arm A and Arm B and overall Safety population for the shifts in these categories from baseline to selected post -treatment assessment time points (e.g., low to normal, low to high, high to low). Percentages for the shift tables will be calculated based on the number of subjects who had results for both baseline and the corresponding post- treatment assessment time point. • For continuous parameters, descriptive statistics will be presented for the changes from baseline to each selected post -treatment assessment time point. 9.3 Vital Signs and Weight Subjects will be monitored before, duri ng and aft er tremelimum ab and durval umab infusi on w ith assessment of vital signs as presented in section 6.5 of the protocol. • Descri ptive stat istics will be presented each timepoint. • Descriptive statistics will also be presented fo r the changes in vi tal signs from bas eline to each post-tr eatment asse ssment time point. 9.4 Electrocardiograms 12-Lead ECG will be completed at screening/baseline visit, Day 1 of cycles 1, 2, 4, 6, 8, 10 and 12 and the +28 day post last treatment visit. • Baseline and post -baseline assessments will be classified as normal, abnormal – not clinically significant, or abnormal – clinically significant. The baseline value will be the pre-dose assessment for each formulation, and the post -baseline value will be t he worst post-baseline assessment for each formulation. Sponsor: Ludwig Institute for Cancer Research.