In a separate listing the KRAS mutation analysis details will be presented. 4.5.3 Medical History (Excluding Resected cancer) Medical history will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA ) version 1 5.1 or hig her. The number and percentage of patients with current medical history events, defined as those recorded as ‘ongoing’ on the eCRF will be tabulated by system organ class (SOC), preferred term (PT) for each group. SOCs will be ordered in decreasing freque ncy of the total number of patients with current medical histories reported in each SOC and PTs will be ordered within a SOC in decreasing frequency of the total number of patients with each current medical history . This summary will be repeated for past m edical history events, defined as those not recorded as ‘ongoing’ on the eCRF. All medical history events (excluding resected pancreatic cancer) will be listed by SOC and PT. 4.5.4 Prior and Concomitant Medication Concomitant medications will be coded according to the World Health Organization Drug dictionary (WHODrug) (Standard) version of September 2012 or later. Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 10 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 Prior medications are defined as those for which the end date is prior to the date of first IMP admini stration. Concomitant medications are defined as those which are indicated as ‘Ongoing’ on the date of first IMP administration, or those which s tart on or after the date of first IMP administration , or those which start prior to date of first IMP administration and have an end date after the first IMP administration. If medication dates are incomplete and it is not clear whether the medication was concomitant, it will be assumed to be concomitant. The number and percentage of patients who took any concomitant medications will be presented by medication class and standardised medication names sorted alphabetically. All prior and concomitant medications will be listed by r eported name, medication class, standardised medication name, indication, dose, dose unit, frequency, route of administration, start date and end date or ‘ongoing’ flag. Concomitant medications will be flagged. All medications which start up to four weeks prior to first dose of IMP will also be flagged in the listings. 4.5.5 Prophylaxis Prophylaxis medication will be coded according to the WHODrug (Standard) version of September 2012 or later . The number and percentage of patients who had any prophylaxis medications will be presented by medication class and standardised medication names sorted alphabetically. All prophylaxis medications will be listed by reported name, medication class, standardised medication name, indication, dose, dose unit, frequency, route of administration, start date and end date or ‘ongoing’ flag. 4.6 Investigational Medicinal Product Administration All d etails of GM-CSF/TG01 administration will be listed alongside with TG01 administration for DTH test details , including derived variables as described in Section 5.1. The gemcitabine administration details will be listed separately from the 5-FU/leucovorin administration details. 5 SAFETY EVALUATION All safety evaluations will be performed on the AT P analysis set. Adverse events and laboratory values collected during the study are the primary safety endpoints of interest. Unscheduled laboratory samples or clinical evaluations may be taken if parameters are out of range.