Totally confined to bed or chair 5 Dead 6. ANALYSIS OF TRIAL DATA 6.1 Study Endpoints 6.1.1 Primary Endpoint The primary safety endpoint is the assessment of adverse events and l aboratory values during the study period. The primary efficacy endpoint is immune response by week 11 or 12 (main group) or by week 13 (concomitant group) or by week 8 (modified vaccination group) , at end of the treatment period with chemotherapy and at week 52. 6.1.2 Secondary Endpoints The secondary target variables for this trial are: Efficacy • Time from randomisation to first disease progression or deat h from any cause • Time from randomisation to death CT TG01 -01 Version v 10.0 27 June 2018 Confidential 69 / 87 6.1.3 Exploratory Endpoints • Relationship between KRAS status in resected primary tumour and recurrence survival outcomes (including disease recurrence and overall survival) • CA19 -9 levels 6.2 Definitions of evaluabili ty The definitions of study populations are as follows: Population Definition All treated patients (ATT) /safety This will comprise all patients who received at least one dose of Investigational pharmaceutical product (IMP) Immune This will comprise pati ents who provided at least one set of T cell and/or DTH response results Modified Immune This will comprise all patients in the Immune population who have received at least one cycle of gemcitabine or 5 -FU/leucovorin Patients who withdrew from study before completing 1 cycle of gemcitabine may be replaced. 6.3 Analytical methods Endpoints will be analysed as detailed in the sections below: 6.3.1 Primary e ndpoints Summary measures: 6.3.1.1 Nature, incidence and severity of adverse events Adverse events will be summ arised by counts and proportions (percentages) of patients reporting an AE expressed as a percentage of all patients. All premature terminations will be summarised by the primary reason for trial withdrawal ; ITT population. 6.3.1.2 Laboratory assessments Summary measures: Standard summary statistics; ITT population. Listings will highlight assessments of clinical significance. 6.3.1.3 Incidence of and reasons for Study Drug dose interruptions, Study Drug dose reductions and withdrawals Summary measures: Counts and proportions; ITT population. 6.3.1.4 Study Drug exposure Summary measures: Standard summary statistics; ITT population. Listings will highlight assessments of clinical significance. CT TG01 -01 Version v 10.0 27 June 2018 Confidential 70 / 87 6.3.1.5 Immune response Summary measures: DTH test results, T -cells assay; Per Protocol population and Immune population. The data will be summarised.