8 4.5.1 Demography ............................................................................................................................ 9 4.5.2 Medical History of Pancreatic Cancer and KRAS Mutation Analysis ...................................... 9 4.5.3 Medical History (Excluding Resected cancer) ......................................................................... 9 4.5.4 Prior and Concomitant Medication .......................................................................................... 9 4.5.5 Prophylaxis ............................................................................................................................ 10 4.6 Investigational Medicinal Product Administration ..................................................................... 10 5 SAFETY EVALUATION ................................................................................................................ 10 5.1 Study Drug Exposure ................................................................................................................ 11 5.1.1 GM-CSF/TG01 ....................................................................................................................... 11 5.1.2 Gemcitabine ........................................................................................................................... 11 5.1.3 5- FU/Leucovorin .................................................................................................................... 11 5.2 Adverse Events ......................................................................................................................... 12 5.3 Deaths ....................................................................................................................................... 13 5.4 Clinical Laboratory Evaluation .................................................................................................. 13 5.4.1 Haematology .......................................................................................................................... 14 5.4.2 Biochemistry including INR .................................................................................................... 15 5.4.3 Urinalysis ............................................................................................................................... 15 5.5 Vital Signs ................................................................................................................................. 15 5.6 Electrocardiogram (ECG) ......................................................................................................... 15 5.7 Physical Examination and Eastern Cooperative Oncology Group (ECOG) Performance Status .................................................................................................................................................. 15 6 EFFICACY EVALUATION .............................................................................................................