Do not make unauthorized copies. If the study agent is completed or discontinued before disease recurrence the subject will be followed for recurrence on the following schedule. Radiological assessment of disease status until disease recurrence (i.e., chest X -ray, (chest CT or MRI is acceptable), pelvic/abdominal CT or MRI) performed quarterly (every 3 months ±7 days). The methods used for prestudy assessments (e.g., CT or MRI) should be used throughout the study and if possible, the same equipment should be used each time. Radiology tumor assessment will be summarized with descriptive statistics in a summary table. A detailed listing will be provided. SAFETY The safety population will be used for all the analyses of safety data. Exposure to Study Drug Study treatment dosing compliance will be summarized with descriptive statistics by treatment group. All exposure and compliance data will be provided in data listings. Adverse Events All reported terms (investigator descriptions) for AEs will be coded using the most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) and summarized with frequencies and percentages by treatment group, system organ classification, and preferred term. A treatment- emergent adverse event (TEAE) is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. The following summaries will be presented with frequencies and percentage by treatment group, system organ classification, and preferred term: • All AEs • All TEAEs • TEAEs leading to discontinuation from the study • TEAEs by relation to study treatment • TEAEs by CTCAE severity • All serious TEAEs • Serious TEAEs by relation to study drug • TEAEs with fatal outcome Statistical Analysis Plan IND 014205 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide CL-SAP-00001 Version: 03 Page 18 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.