20 7 References .................................................................................................................................... 21 Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 3 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 ABBREVIATIONS Abbreviation Term 5-FU 5-Fluorouracil AE Adverse Event ALT Alanine aminotransferase AST Aspartate aminotransferase ATP All treated patients BUN Blood urea nitrogen CI Confidence Interval CK Creatinine kinase CRF Case Report Form DFS Disease -free survival DLT Dose -limiting toxicity DTH Delayed Type Hypersensitivity ECG Electrocardiogram ECOG Eastern Cooperative Oncology Group eCRF Electronic case report form GM-CSF Granulocyte macrophage colony stimulating factor IA Interim analysis IAS Immune analysis set IMP Investigational medicinal product INR International normalised ratio ITT Intent ion-to-treat KRAS Kirsten rat sarcoma viral oncogene homolog LDH Lactate dehydrogenase MedDRA Medical Dictionary for Regulatory Activities MIAS Modified Immune analysis set NCI-CTCAE National Cancer Institute- Common Terminology Criteria for Adverse Events OS Overall survival PP Per-protocol PT Preferred Term SAE Serious Adverse Event SAP Statistical Analysis Plan SD Standard Deviation SGOT Serum glutamic oxaloacetic transaminase SGPT Serum glutamic pyruvic transaminase SI Stimulation Index SOC System Organ Class Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 4 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 TEAE Treatment -emergent Adverse Event TFL Tables, figure s and listings UNL Upper Normal Limit WHODrug World Health Organization Drug dictionary Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 5 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 1 INTRODUCTION This document details the statistical analysis of the data that will be performed for the Targovax ASA study: A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients with Resected Adenocarcinoma of the Pancreas. This Statistical Analysis Plan (SAP) is based on protocol final version 9.0 dated 27 June 2016.