Do not make unauthorized copies. Demographic and Baseline Characteristics .............................................................. 15 Prior Disease medications/therapy and Concomitant Medications ........................... 15 Concomitant procedures ........................................................................................... 15 Medical and Surgery History ..................................................................................... 16 Inclusion/Exclusion Criteria ....................................................................................... 16 Protocol Violations/Deviations .................................................................................. 16 EFFICACY ANALYSIS ................................................................................................ 16 Tumor Assessment ................................................................................................... 16 12.1.1 Radi ology Tumor Assessment ........................................................................... 16 SAFETY ....................................................................................................................... 17 Exposure to Study Drug ............................................................................................ 17 Adverse Events ......................................................................................................... 17 Serious Adverse Events and Death .......................................................................... 18 Laboratory Evaluations ............................................................................................. 18 Vital Signs ................................................................................................................. 18 Physical Examinations .............................................................................................. 18 REFER ENCES ........................................................................................................................... 19 Statistical Analysis Plan IND 014205 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide CL-SAP-00001 Version: 03 Page 4 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. Do not make unauthorized copies. ABBREVIATIONS Abbreviation Term ATC Anatomical Therapeutic Chemical BMI Body Mass Index CBC Complete blood count CD Cluster of differentiation CRF Case report form CT computerized tomography CTCAE Common Toxicity Criteria for Adverse Events ctDNA Circulating tumor DNA CTM Clinical Trial Material ELISPOT Enzyme -Linked ImmunoSorbent Spot ESFT Ewing’s Sarcoma Family of Tumors EWS Ewing’s Sarcoma GMCSF Granulocyte Macrophage -Colony Stimulating Factor HR Hazard Ratio IDMC Independent Data Monitoring Committee IFN Interferon ITT Intent to Treat MedDRA Medical Dictionary for Regulatory Activities MRI Magnetic resonance imaging ORR Objective Response Rate OS Overall Survival PBMC Peripheral Blood Mononuclear Cells PFS Progression Free Survival RECIST Response Evaluation Criteria in Solid Tumors SAE Serious Adverse Event STD Standard Deviation TEAE treatment -emergent adverse event WHO World Health Organization Statistical Analysis Plan IND 014205 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide CL-SAP-00001 Version: 03 Page 5 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.