Assessments carried out on day of first IMP administration are considered to have taken place before the IMP administration, if the corresponding times have not been recorded. For post baseline, only data from scheduled visits will be included in the t ables. Patients who attended a visit but have no ECOG data available will be included in the missing and total categor ies. Patients who withdrew prior to the visit will not be included in the summary for that visit, and will be excluded from the denominator for calculation of percentages at that visit . A listing will present ECOG assessment date and ECOG performance status together with whether the physical examination was performed and the dat e of examination. 6 EFFICACY EVALUATION 6.1 Immune Response To assess the immune response to GM -CSF/TG01 (one of the primary objectives of the study ), the primary efficacy endpoint is the proportion of patients with an immune response by Week 11 or 12 (main group) or by Week 13 (concomitant group) or by Week 8 ( modifi ed vaccination group) . The proportion of patients with an immune response by at the end of the treatment period with chemotherapy , at Week 52 and at end of study will also be presented. 6.1.1 Derivation rules An immune response is defined as having a positive DTH skin reaction and/or a positive T-cell response at least once by the end of the initial treatment period ( Week 11 or 12 in main group, Week 13 in concomitant group, W eek 8 in modified vaccination group) excluding Day 1, at the end of the treatment peri od with chemotherapy , at Week 52 and at end of study . The DTH test is considered positive if erythema and/or induration are recorded as positive on the DTH response eCRF page . A patient is considered to have a positive T -cell response if the stimulation index (SI) is ≥ 2. The SI will be derived as follows: Mean (T cells + PBMC +TG01 ) Mean (T cells + PBMC (negative control)) For SI, mean is derived as the sum of the non- missing measurements di vided by the number of non- missing measurements, rounded to the nearest whole number. 6.1.2 Endpoint summaries Where applicable, each summary will use the number of patients with data at that time point as the denominator for the calculation of percentages. The number and percentage of patients with an immune response by Week 11 or 12 (main group) or by Week 13 (concomitant group) or by Week 8 (modified vaccination group), at the end of the treatment period with chemotherapy, at W eek 52, at end of study, and over the entire study course will be presented for the M IAS as the primary analysis. This will be repeated for the IAS as a secondary analysis . Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 17 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 A summary of the number and percentage of patients with at least one positive DTH skin reaction by Week 11 or 12 (main group) or by Week 13 (concomitant group) or by Week 8 (modified vaccination group), at the end of the treatment period with chemotherapy , and at W eek 52 (main and concomitant groups only) will be presented for both the MIAS and IAS . On a separate ta ble the number of positive DTH skin reactions (categorical variable), as well as the number and percentage of patients with positive DTH skin reactions by visit will be presented for both the MIAS and IAS . A summary of the number and percentage of patients with at least one positive T -cell response by Week 11 or 12 (main group) or by Week 13 (concomitant group) or by Week 8 (modified vaccination group), at the end of the treatment period with chemotherapy (modified vaccination group only) , at W eek 52, at end of study, and over entire study course will be presented for both the MIAS and IAS. All details of DTH test and response will be listed, including derived variables.