Do not make unauthorized copies. Treatment-emergent events will be considered as any event occurring after the first dose of treatment drug and prior to a subject’s termination, withdrawal or completion of the study. Prior medications will be those ended before the first study treatment. Concomitant medications are those used on or after the date of first study treatment. STUDY POPULATION Unless otherwise stated, all study population analyses will be performed on the Safety Population. Subject Disposition Subject disposition will be presented for all subjects. The composition of the analysis populations and those who enrolled, completed or discontinued from the study will be summarized by dose cohort and overall with descriptive statistics. Reasons for early discontinuation will be presented with frequencies and percentages for all categories. Demographic and Baseline Characteristics Demographics and baseline characteristics listing will include date of birth, age, gender, ethnicity, race, and height and weight and BMI at screening. Each of these variables except date of birth will also be summarized with descriptive statistics. Prior Disease medications/therapy and Concomitant Medications Concomitant medications will be coded with the World Health Organization (WHO) drug dictionary. Concomitant medications will be summarized with descriptive statistics by drug Anatomical Therapeutic Chemical (ATC) Classification System (level one), generic name, and cohort. A data listing will be included that shows all medications by generic name and verbatim name. Prior medications/therapy will be excluded from the summary but be included in the listing. Concomitant procedures Concomitant procedures will be summarized by indication type, treatment arm, and time point and also will be included in the listing. Statistical Analysis Plan IND 014205 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide CL-SAP-00001 Version: 03 Page 16 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.