Do not make unauthorized copies. Medical and Surgery History Medical history will be summarized with descriptive statistics by medical history code and treatment group. A comprehensive data listing will also be included. Inclusion/Exclusion Criteria Inclusion and exclusion criteria failures will be included in a data listing. Protocol Violations/Deviations Protocol violations will be summarized with descriptive statistics by category. A listing of all events will also be included. Major protocol deviations include, but are not limited to the following: • Non-fulfillment of all inclusion criteria or fulfillment of at least one exclusion criteria; • No consent form found; • Other relevant deviations, to be judged on an individual basis. Minor protocol deviations include, but are not limited to: • Measurements obtained outside the visit window to a limited degree; • Other deviations will be judged on an individual basis. EFFICACY ANALYSIS Tumor Assessment Disease recurrence will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Eisenhauer, Therasse et al. 009). RECIST response will be summarized with descriptive statistics. Local and central radiology tumor assessment will be performed in this study, summary of the tumor assessment will be presented. 12.1.1 Radiology Tumor Assessment Radiology tumor assessment will be performed within 4 weeks of the registration. Statistical Analysis Plan IND 014205 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide CL-SAP-00001 Version: 03 Page 17 of 19 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document.