Otherwis e, ass ign end of study d ate. 11.2 Safety Data Handling Adver se event toxicity grade w ill be cla ssified using NCI-CTCAE Version 4.03 cr iteria (Grade 1 – Grade 5). If a subject has multiple occurre nces of the same system organ class (SOC) or Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 20 of 27 preferred term, then only the most sever e event will be summar ized in the tables for that SO C and preferred term. Ad verse events of ≥ Grade 3 w ill also be summ arized. A missing toxicity grade will not be impute d. The AE analysis w ill be repeated for SA Es and A Es leading to dose re duction or discontinua tion. 11.3 Coding Dictionaries Medi cal history, A Es, and concurrent procedure s will be coded using Medi cal Dic tionary f or Regula tory Activities (MedDRA V2 0). Prior and conco mitant medi cations w ill be coded using the Wor ld Health Organiza tion Drug Dic tionary (WhoDrugDDEB2_201703). 11.4 Pooling of Centers in Multi- Center Trials There will be no pooling of centers. 11.5 Multiple Comparisons/Multiplicity No adjustments for multiple comparisons or multiplicity will be made. 11.6 Examination of Subgroups No subgroup analysis will be performed in this study. 11.7 Interim Analysis and Data Monitoring Interim Safety R eviews w ill be pe rformed to assess DL Ts in the dose ev aluation cohorts for determinat ion of RC D. Interim an alyses may be performed to anal yze the 8- and 24- week endpoin ts. 12.0 QUALITY CONTROL All data displays and analyses will adhere to the International Conference on Harmonisation (ICH) Harmonized Tripartite Guideline: Structure and Content of Clinical Study Reports (ICH Topic E3). The clinical monitor will verify that the clinical study is conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCPs, and any applicable regulatory requirements. Ludwig Institute for Cancer Research (LICR) or their designee will review all tables, listings, and figures prior to final database lock. Final SAS datasets, programs and outputs will be transferred to LICR at project completion. Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 21 of 27 13.0 TABLES AND LISTING CONVENTIONS Mock -ups for statistical tables and listings will be provided. Final formats for the statistical tables and listings may deviate from these mock -ups upon agreement with LICR . Footnotes will be used as needed to clarify the information that is presented in the tables and listings. Unless otherwise requested by LICR , the term ‘subject’ wi ll be used in all tables and listings, in accordance with CDISC standards. The numbering of tables, figures and listings will be in the following order: Table 14.x.y.z, Figures 15.x.y.z, Listings 16.x.y.z. The general layout of tables and listings will be as follows: All tables and listings will use landscape orientation. Margins will be at least 2.0 cm at the top and bottom and at least 0.8 cm on the left and right, excluding headers and footers, in accordance Ludwig Institute for Cancer Research . Page x of y Protocol: LUD2014-012-VAC Run Date: DDMMMYY - HH:MM Clinical Study Report Listing 16.2_x (or Table 14.x_x) <Title> <Population> Col 1 Col 2 Col 3 etc. ____________________________________________________________________________ _____________ __________________________________________________________________________________________ _ <Any footnotes> File Name: <pathname for SAS program> Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 22 of 27 with electronic Common Technical Document ( eCTD) guidelines. Font will be Courier New, unless otherwise specified, with an 8-point font size in most cases.