Do not make unauthorized copies. CONSIDERATIONS FOR DATA ANALYSIS Programming Environment All analyses will be conducted using SAS® version 9. 0. Statistical Notation and Methodology Unless stated otherwise, the term “descriptive statistics” refers to the number of subjects (n), mean, median, standard deviation (STD), minimum (min), and maximum (max) for continuous data and frequencies and percentages for categorical data. Min and max values will be rounded to the precision of the original value, means and medians will be rounded to 1 decimal place greater than the precision of the original value, and STDs will be rounded to 2 decimal places greater than the precision of the original value. Percentages will be rounded to the nearest whol e number (zeros are not displayed) with values of “< 1%” and “> 99%” shown as necessary for values falling near the boundaries. P -values will be presented with 3 decimal places and values less than 0.001 will be presented as < 0.001. Unless otherwise noted, all data collected during the study will be included in data listings and will be sorted by cohort, subject number and then by date/time for each subject number. DATA HANDLING METHOD S Missing Data 10.1.1 Date Values In cases of incomplete dates (e.g., pertaining to AE, concomitant medication, medical history, etc.), the missing component(s) will be assumed as the most conservative value(s) possible. For example, if the start date has a missing day value, the first day of the month will be imputed for study day computations (i.e., treatment-emergent status, etc.). If day is missing for an end date, the last day of the month will be imputed. Similar logic will be assumed for missing month and year components. Date imputation will only be used for computational purposes e.g., treatment-emergent status, etc. Actual data values as they appear in the original CRFs will be shown in the data listings. Statistical Analysis Plan IND 014205 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide CL-SAP-00001 Version: 03 Page 14 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.