Do not make unauthorized copies. For all AE summaries, events will be counted only once for a given subject by primary SOC and preferred term. When an adverse event occurs more than once for a subject, the maximum severity and causality will be used. All AEs will be included in comprehensive data listings. A separate listing will be included for AEs leading to discontinuation from study and AEs with fatal outcome. Serious Adverse Events and Death Separate data listings and summaries will be presented for all SAEs and deaths. Laboratory Evaluations Laboratory assessments and change from baseline will be summarized with descriptive statistics by panel, test, treatment group, and time point. Additionally, abnormal results will be summarized with frequencies and percentages by clinical significance, panel, test, treatment group, and time point. A data listing will display all laboratory test results and findings. Vital Signs The results of change from baseline of vital signs will be summarized with descriptive statistics by treatment group and time point. A data listing of all data will also be included. Physical Examinations The results of physical examinations will be summarized with frequencies and percentages by category, treatment group, and time point. A data listing of all results will also be included. Statistical Analysis Plan IND 014205 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide CL-SAP-00001 Version: 03 Page 19 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.