Interim reports will be provided within one month of completing the agreed patient analyses. A final report is expected no more than 10 weeks after the last sam ple is analysed. The data will be reported in tables and graphs/ figure s. No formal statistical analysis is planned. The results will be summarised in the CSR and the final report included as an appendix. 5.13.3 Tertiary endpoints SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 23 SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 24 SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 25 5.14 Other statistical analysis 5.14.1 Stratification and covariate analysis No stratification or covariate analysis is planned. 5.14.2 Multivariate analysis No multivariate analysis is planned. 5.14.3 Subgroup analysis Given the small number of patients to be vaccinated, no subgroup analyses are planned. 5.14.4 Interim analysis An interim analysis will be conducted once all patients administered AST -VAC2 have withdrawn, died or completed their 2- year follow -up visit for survival. Once this condition is met, a data cut -off will be established. All patient visits occurring on or before this date will be analysed and summarised in the clinical study report including safety data to date and assessment of OS at 2 years. Any data collected after this date will be summarised in a supplemental report produced for the final analysis to satisfy the safety reporting requirements for AST -VAC2 as an advanced therapy investigational medicinal product (ATIMP ). The relevant data will be uploaded to ClinicalTrials.gov after the CSR is approved. 5.14.5 Final analysis The final analysis will be conducted after one of the following conditions is met: • The trial is terminated early (e.g. due to toxicity) • The End of Trial has been reached (defined as the date when all patients have either withdrawn from the trial or died, or the last patient has completed their final follow- up visit [whichever is the latter]. The final follow -up visit is scheduled to take place 5 years after t he patient’s first vaccination) . Once one of the conditions is met, a data cut -off date will be established. All patient follow -up visits occurring on or before this date will be analysed and summarised in a supplemental report. SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 26 6. TABLES LISTINGS AND FIGURES 6.1 LISTING S CSR Appendix Subsection CSR Listing Number Listing New Listing Name for CSR 16.2.1 Discontinued Patients 16.2.1.1 Vaccine Received Vaccine Received 16.2.1.2 End of Vaccination Vaccination Completion 16.2.2 Protocol Deviations 16.2.2.1 To be provided from the central deviation tracker N/A 16.2.3 Patients excluded from Efficacy Analysis 16.2.3.1 Enrolment Enrolled Patients 16.2.4 Demographic and Baseline Data 16.2.4.1 Demographics Patient Demography 16.2.4.2 Diagnosis Diagnosis of Primary Disease 16.2.4.3 Medical History Medical History 16.2.4.4 Medical Procedures Medical Procedures 16.2.4.5 Prior and Concomitant Medication s Prior and Concomitant Medication s 16.2.4.6.1 Surgery Previous Treatment for Malignant Disease - Surgery 16.2.4.6.2 Chemotherapy/other therapy Previous Treatment for Malignant Disease – Chemotherapy/Other Therapy 16.2.4.6.3 Radiotherapy Previous Treatment for Malignant Disease - Radiotherapy 16.2.4. 7 Physical Examination Physical Examination 16.2.4. 8 Chest X-ray Results Chest X -ray 16.2.5 Compliance and Drug Administration 16.2.5.1 Drug Administration - Vaccination Drug Administration - Vaccination 16.2.6 Efficacy Response 16.2.6.1 Immune Response Index Lesions Immune Response Index Lesions 16.2.6.2 Immune Response Non-Index Lesions Immune Response Non -Index Lesions 16.2.6.3 Immune Related Response Criteria Immune Related Response 16.2.6.4 New Anti-Cancer Therapy New Anti -Cancer Therapy 16.2.6.5 Survival Survival 16.2.6.9 CEA Sample CEA Sample 16.2.7 Safety 16.2.7.1 Adverse Events Adverse Events SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 27 16.2.7.2 Adverse Events by SOC Adverse Events by SOC 16.2.7.3 Follow -Up Follow Up 16.2.7.4 WHO WHO Performance Status 16.2.7.5 Haematology Haematology : Haemoglobin, WBC, Neutrophils, Lymphocytes , Eosinophils, Platelets 16.2.7.6 Biochemistry Biochemistry : Sodium, Potassium, Adjusted calcium, Phosphate, Urea, Creatinine, Total Protein, Albumin, Bilirubin, ALP, ALT, AST, CRP 16.2.7.7 Urinalysis Urinalysis : Glucose, Protein, Blood, pH 16.2.7.8 Vital Signs Vital Signs 16.2.7.9 Pregnancy Pregnancy 16.2.7.10 ECG ECG 6.2 SUMMARY TABLES Table Number in RAP CSR Table Number Table Name Table 1 N/A Trial Design N/A: to be produced as part of lab reporting In-text table Human Leucocyte Antigen Status at Screening Table 2 14.1.1 Summary of Patient Demography (Full Analysis Population) Table 3 14.1.2 Primary Diagnosis at Baseline (Full Analysis Population) Table 6 14.1. 3 Summary of B aseline Disease Sites (Full Analysis Population) Table 4 14.1.