For now, these biomarkers have not been identified, and no summary statistics are planned in this SAP. The DFS, OS and CA19 -9 analyses will be repeated for the subgroup of patients who received Gemcitabine only. 3 years survival estimates will be presented for DFS and OS for the main and concomitant groups. Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 8 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 4 STUDY PATIENT S 4.1 Analysis Sets Assignment of patient s to analysis se ts will be agreed between the s tudy statistician and the Sponsor prior to database lock , once all study data are available and verified. All Treat ed Patients (ATP) : Defined as those patient s who receive at least one dose of IMP which is either TG01, GM -CSF, gemcitabine or 5-FU/ Leucovorin. This analysis set will be used to assess the safety and survival endpoints. Immune Analysis Set (IAS): Defined as those patient s who provide at least one set of T cell and/or delayed type hypersensitivity ( DTH) response results. Modified Immune Analysis Set (MIAS): D efined as all patients in the IAS who have received at least one cycle of gemcitabine or 5-FU/leucovorin. Assessment of the immune response endpoint will be based on the IAS and MIAS . The MIAS will serve as the primary analysis set for the assessment of immunology data whereas the IAS will be considered the secondary analysis set. All treated patient s will be listed indicating their eligibility to IAS and MIAS and reasons for exclusion from these analysis sets as appropriate. 4.2 Disposition of Patient s The following patient disposition details will be summarised and will include the number and percentage of patients: • included in each analysis set (A TP, IAS and MIAS ) • who completed the study • who prematurely withdrew (including a breakdown of the primary reasons for withdrawal) Individual reasons for withdrawal will be presented in the listing for all treated patient s. 4.3 Eligibility All responses to the inclusion and exclusion criteria will be listed including a column detailing which protocol version the patient entered the study . In a separate listing all pregnancy test results and details will be presented. 4.4 Protocol Deviations Details of all protocol deviations (start and end dates, deviation category and specific details) will be listed. 4.5 Demographic and other Baseline Characteristics Summaries of demographic and other baseline characteristics will be based on the ATP analysis set . Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 9 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 4.5.1 Demography Demographic char acteristics (age, sex and race) and body measurements (heig ht and weight collected at Screening) will be summarised . Age will be c alculated in years from the date of birth to the date of informed consent .