Results from unscheduled samples and assessments will be listed but will not be included in the summaries described below. Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 11 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 5.1 Study Drug Exposure 5.1.1 GM-CSF/TG01 The duration of exposure to GM -CSF/TG01 in days, as well as the total dose of GM - CSF and the total dose of TG01 separately for vaccination, DTH testing, and vaccination and DTH testing combined will be summarised . Duration of exposure to GM -CSF/TG01 will be calculated as: date of last GM - CSF/TG01 administration – date of first GM-CSF/TG0 1 administration + 1. Total dose of GM -CSF will be calculated as: sum of administered dose (dose strength*volume) at each visit. Total dose of TG01 for DTH testing will be calculated as: sum of administered dose (dose strength*volume) for DTH test at each visit. Total dose of TG01 for vaccination will be calculated as: sum of administered dose (dose strength*volume) for vaccination at each visit. Total dose of TG01 for vaccination and DTH testing combined will be calculated as: sum of administered dose (dose strength*volume) for vaccination at each visit + sum of administered dose (dose strength*volume) for DTH test at each visit. The number of injections of GM -CSF/TG01 , number of injections of TG01 for DTH test, and total number of injections ( GM-CSF/TG01 + DTH) will be summarized overall and for the following periods: before chemotherapy , during chemotherapy, and after chemotherapy. The number and percentage of patients with dose delays and discontinuation for GM- CSF/TG01 , together with the frequency and reasons for such dose modifications, will be summarised by visit and overall. 5.1.2 Gemcitabine The duration of exposure to Gemcitabine in days , as well as the number of cycles , number of injection s of Gemcitabine and the total dose of Gemcit abine will be summarised. Duration of exposure to Gemcitabine will be calculated as: date of last Gemcitabine administration – date of first Gemcitabine administration + 1. Total dose of Gemcitabine will be calculated as: sum of administered dose at each injection . The number and percentage of patients with dose delays, reductions and discontinuation for Gemcitabine, together with the frequency and reasons for such dose modifications, will be summarised by cycle and overall. 5.1.3 5-FU/Leucovorin The duration of exposure to 5- FU/Leucovorin in days, as well as the number of cycles , number of injection s of 5 -FU/Leucovorin and the total dose of 5-FU/Leucovorin will be summarised. Duration of exposure to 5-FU/Leucovorin will be calculated as: date of last 5- FU/Leucovorin administration – date of first 5 -FU/Leucovorin administration + 1 . Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 12 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 Total dose of 5- FU/Leucovorin will be calculated as: sum of administered dose at each injection . The number and percentage of patients with dose delays, reductions and discontinuation for 5-FU/Leucovorin, together with the frequency and reasons for such dose modifications, will be summarised by cycle and overall. 5.2 Adverse Events Any events that are unequivocally due to progression of disease will not be reported as adverse events ( AEs) or serious AEs ( SAEs ). AEs will be coded according to MedDRA version 15.1 or higher . A treatment -emergent adverse event (TEAE) is defined as an AE with start date/time on or after the first administration of IMP, or AEs with worsening severity on or after the first administration o f IMP. A pre -treatment AE is defined as an AE with start date/time prior to the first administration of IMP. AEs with unknown start date/time will be assumed to be treatment -emergent unless the end date/time is known to be before the first administration of IMP . Assessment of AE severity will be based on the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI -CTCAE, version 4.0) graded as 1-5 grades , with grade 5 being death. For AEs that cannot be assessed based on the NCI-CTCAE, severity will be assessed as mild, moderate, severe o r life-threatening. In summary tables, severity will be grouped as grade 1/mild, grade 2/moderate, grade 3/severe, grade 4/life threatening, and grade 5. If the severity of an event changes during the course of that event, only the maximum severity / grade will be summarised in the tables. The relationship to each IMP (TG01, GM -CSF, Gemcitabine, 5 -FU and L eucovorin) is assessed as not related or related. An overview summary table will summarise the number of events and the number and percentage of patients with at le ast one of the following TEAES : • total TEAEs • total serious TEAEs • total IMP related serious TEAEs • total DLTs • TEAEs leading to TG01 and GM -CSF withdrawal • TEAEs leading to Gemcitabine, 5 -FU or Leucovorin withdrawal • TEAEs leading to study withdrawal • TEAEs leading to death • TEAEs by severity • TEAEs by relationship to each IMP (related, not related) separately The number of events and the number and percentage of patient s experiencing TEAEs will be presented by SOC and PT . SOC and PT will be presented in decreasing Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 13 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 frequency of the total number of patient s with TEAEs. If a patient experienced more than one TEAE , the patient will be counted once for each SOC and once for each PT. Serious TEAEs will be summarized in an identical fashion. The number of events and the number and percentage of patient s experiencing TEAEs that are DLTs will be presented by SOC and PT . SOC and PT will be presented in decreasing frequency of the total number of patient s with TEAEs. If a patient experienced more than one TEAE considered to be DLT , the patient will be counted once for each SOC and once for each PT . The number of events and the number and percentage of patient s experiencing TEAEs will be presented by SOC, PT and severity. SOC and PT will be presented in decreasing frequency of the total number of patient s with TEAEs . If a patient experienced more than one TEAE, the patient will be coun ted once for each severity experienced during the study . The number of events and the number and percentage of patient s experiencing TEAEs will be presented by SOC , PT and relationship to each IMP . SOC and PT will be presented in decreasing frequency of the total number of patient s with TEAEs. If a patient experienced more than one TEAE, the patient will be counted once for each SOC and once for each PT at the closest relationship to study drug. This summary w ill be repeated for serious TEAEs only. The number of events related to TG01 and the number and percentage of patient s experiencing TEAEs related to TG01 will be presented by SOC, PT and severity. For this table, grade 1 and 2 events will be pooled. SOC and PT will be presented in decreasing frequency of the total number of patient s with TEAEs . If a patient experienced more than one TEAE, the patient will be counted once for each severity experienced during the study . TEAEs related to GM -CSF, TEAEs related to TG01 and/or GM -CSF and TEAEs related to TG01 and/or GM -CSF only (i.e., events not related to chemotherapy) will be summarized in an identical fashion. All TEAEs details will be listed with a separate listing for pre -treatment AEs. Separate listing of all serious TE AEs and pre- treatment SAEs will also be presented. 5.3 Deaths The total number and percentage of patients who died whilst on the study will be summarised and by cause of death (due to the patient’s disease or AE ). The statement of death details will be listed presenting date of death, primary and secondary cause of death, whether the death was related to the patient’s disease or related to an AE and whether an autopsy was performed. 5.4 Clinical Laboratory Evaluation Data for haematology, biochemistry, urinalysis and clotting screen parameters will be received from laborator ies local to the trial centres . Parameters will be tabulated and listed in the order shown in Table 1. International Normalized Ratio ( INR) will be presented with the biochemistry parameters. For each laboratory parameter, the baseline value will be defined as the last scheduled or unscheduled value collected prior to first dose of IMP. Assessments carried out on day of first IMP administration are considered to have taken place before the IMP Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 14 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 administration, if the corresponding times have not been recorded. For post baseline, only data from scheduled visits will be included in the summary tables.