69 6.3.1 Primary endpoints ........................................................................................... 69 6.3.1.1 Nature, incidence and severity of adverse events ............................................ 69 6.3.1.2 Laboratory assessments ................................................................................... 69 6.3.1.3 Incidence of and reasons for Study Drug dose interruptions, Study Drug dos e reductions and withdrawals ......................................................................... 69 6.3.1.4 Study Drug exposure ....................................................................................... 69 6.3.1.5 Immune response ............................................................................................ 70 6.3.2 Secondary endpoints ....................................................................................... 70 6.3.2.1 Disease- free survival ....................................................................................... 70 6.3.2.2 Overall survival ............................................................................................... 70 6.3.2.3 CA19 -9 Evaluation .......................................................................................... 70 6.3.2.4 Other biomarkers ............................................................................................. 70 6.4 Sample size and power .............................................................................................. 70 7. DRUG SAFETY ...................................................................................................................... 70 7.1 Definitions of adverse events and serious adverse event s ......................................... 70 7.1.1 Adverse events ................................................................................................ 70 7.1.2 Serious adverse events .................................................................................... 71 7.2 Recording of adverse events ...................................................................................... 72 7.2.1 Exposure to GM-CSF and TG01 or chemotherapy during pregnancy/lactation73 7.3 Procedure fo r reporting serious adverse events ......................................................... 73 7.4 Death .........................................................................................................................