This listing will be sorte d by site, patient , visit, and the standard operating procedure ( SOP ) version. 6.2 Survival Assessments The secondary objective of the study is t o assess at 2 years the clinical efficacy of GM-CSF/TG01 . This will be assessed by two secondary efficacy endpoints: • Disease –free survival ( DFS) • Overall survival (OS) The ATP analysis set will be used to assess these endpoints. A listing presenting the date of first IMP administration , date of surgery, date of first disease recurrence, date of death, D FS estimates and OS estimates (separately for time from date of first IMP administration and time from date of surgery) will be displayed for all treated patients. Censored DFS and OS observations will be flagged against each estimate. 6.2.1 Disease- free survival (DFS) DFS is defined by two separate approaches: • the number of weeks from first administration of IMP until the first documented disease recurrence or death from any cause and • the number of weeks from surgery until the first documented disease recurrence or death from any cause. DFS1 = [(the earliest of: first documented disease recurrence or death from any cause) – date of first IMP administration + 1] / 7. DFS2 = [(the earliest of: first documented disease recurrence or death from any cause) – date of surgery + 1] / 7. The first IMP administration is defined as the earliest date of: • The start date of TG01 or GM -CSF administration or Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 18 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 • T he start date of the chemotherapy regimen Date of disease recurrence is defined as the earliest date of disease recurrence recorded on the Disease Assessment form in the eCRF. Date of death is recorded on the Statement of D eath form in the eCRF. It is expected (although not mandated) that a computed tom ography ( CT) scan will be performed every 6 months from start of IMP and if there is clinical evidence of disease recurrence. If a patient has not had an event (disease recurrence or death) before the end of the 2-year follow -up, then DF S1 and DFS2 will be censored at the completion /withdrawal date. If a patient withdrew participation in the study before disease recurrence or death then DFS1 and DFS2 will be censored at the date that they were last known to be recurrence free. If the patient has no post-IMP disease assessment, then DFS1 will be censored at the date of first IMP administration. If the patient has no post -surgery disease assessment, then DFS2 will be censored at the date of surgery. For DFS1 t he number and percentage of patients with events and censored will be summarised along with the minimum and maximum DFS1 time . Kaplan- Meier estimates of the 25th percentile, median and 75th percentile DFS1 time and their associated 95% confidence intervals (CIs) will also be presented. The table will also include the D FS1 rate and 95% CI s at 1,2 and 3 years, again estimated using Kaplan- Meier . DFS1 rate at 3 years will only be presented for the main, concomitant and main + concomitant groups. An identical summary will also be produced for DF S2. Both DFS1 and DFS2 will also be presented graphically using a Kaplan- Meier plot and a swimmer plot . Details of disease assessment will be listed . 6.2.2 Overall survival (OS) OS is defined by two separate approaches: • the number of weeks from first administration of IMP to death due to any cause and • the number of weeks from surgery to death due to any cause. OS1 = [(date of death from any cause) – date of first IMP administration + 1] / 7. OS2 = [(date of death from any ca use) – date of surgery + 1] / 7. The first IMP administration is defined as the earliest date of: • The start date of TG01 or GM -CSF administration or • T he start date of the chemotherapy regimen Date of death will be recorded on the S tatement of D eath form in the eCRF. If a patient has not had an event (death) before the end of the 2- year follow -up, then OS1 and OS2 will be censored at the completion/withdrawal date. If a patient withdrew particip ation in the study before death then OS 1 and OS2 will be censored at the date that they were last known to be alive. Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 19 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 For OS1 the number and percentage of patients with events and censored will be summarised along with the minimum and maximum OS1 time. Kaplan -Meier estimates of the 25th percentile, median and 75th percentile OS 1 time and their associated 95% CIs will also be presented. The table will also include the OS 1 rate and 95% CI s at 1 ,2 and 3 years , again estimated using Kaplan -Meier . OS1 rate at 3 years will only be presented for the main, concomitant and main + concomitant groups. An identical summary will also be produced for OS2. OS1 and OS2 will also be presented graphically using a Kaplan- Meier plot and a swimmer plot . Listing of the survival follow -up details will be presented. 6.2.3 Swimmer Plots A swimmer plot will be produced, displaying the DFS1 and OS1 times for each patient including whether they experienced an event or were censored for each endpoint. This plot will be repeated for DFS2 and OS2 times. 6.3 Exploratory Analysis 6.3.1 Relationship between KRAS status and recurrence survival outcomes The summar ies of DFS 1 and DFS2 will be presented by KRAS mutation detected (Yes/No) for the ATP analysis set . DFS1 by KRAS mutat ion and DFS2 by KRAS mutation will also be presented graphically using a Kaplan- Meier plot. 6.3.2 CA19 -9 levels and other biomarkers Summary statistics of observed CA19 -9 levels , absolute change from baseline and percentage change from baseline will be summaris ed by visit for the ATP analysis set . Baseline is defined as Day 1 CA19 -9 result. Individual patient CA19- 9 values up to 1 year after first dose of IMP will be plotted, with separate figures for each group. Additionally, box plots will be produced to summa rize values over time, with separate pages for each group. All the blood collection details for CA19- 9 including the result, will be listed with the blood collection details for the other biomarkers. 6.4 Examination of subgroups The DFS and OS summaries and Kaplan- Meier plots (sections 6.2.1and 6.2.2 ) and CA19 -9 levels tabulation (section 6.3.2 ) will be repeated for the subgroup of patients who received Gemcita bine only. 6.5 Interim analyses An interim analysis (IA) will be performed when 1- year data are available for the M ain and Concomitant groups. The following tables and figures will be provided: • Table 14.1.1 Patient disposition Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 20 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 • Table 14.1.2 Demography • Table 14.1.3 Medical History of Pancreatic Cancer • Table 14.1.4 KRAS Mutation Analysis • Table 14.1.7 Prophylaxis • Table 14.1.8.1 TG01 and GM -CSF Administration – Patient Level • Table 14.1.9.1 Gemcitabine Administration – Patient Level • Table 14.1.10.1. 5- FU and Leucovorin Administration – Patient Level • Table 14.2.1.1 Immune Response (MIAS) • Table 14.2.2.1 DTH Skin Test Reactions – By Study Period (MIAS) • Table 14.2.3.1 DTH Skin Test Reactions – Overall (MIAS) • Table 14.2.4.1 T -cell Responders (MIAS) • Table 14.2.5.1 Di sease- free Survival (DFS1) (ATP) • Table 14.2.6.1 Disease- free Survival (DFS2) (ATP) • Table 14.2.7.1 Overall Survival (OS1) (ATP) • Table 14.2.8.1 Overall Survival (OS2) (ATP) • Table 14.2.11.1 CA19- 9 Values (U/ml) and Change from Baseline over Time • All adverse event tables (Table 14.3.1 to Table 14.3. 12 inclusive) • Table 14.3.