of Patients. Table 8: Frequency of All Adverse Events (Safety Population) SYSTEM ORGAN CLASS Preferred Term No. of Episodes Reported No. of Patients N=XX All AEs N N (%) BLOOD AND LYMPHATIC… Anemia CARDIAC DISORDERS Sinus tachycardia Etc There will be additional versions (as required) of the above table based on pre -treatment AEs, TEAEs , treatment emergent SAEs (any AE that is considered Serious) and related TEAEs. Overview of TEAEs will be presented for all patients. An AE is considered to have led to withdrawal if an adverse event with “Did the AE cause the subject to be discontinued from the study?” is recorded as yes. Table 9: Overview of Treatment Emergent Adverse Events (Safety Population) Patients with TEAEs Overall No. of Patients N=XX Patients with >=1 TEAE N (%) Patients with >= 1 TE SAE Patients with >= 1 related TEAE Patients with >= 1 CTCAE Grade 3, 4 or 5 TEAE Patients with >= 1 AE leading to withdrawal * Patients who died due to TEAE *Footnote: AEs that lead to withdrawal of vaccination ; patients remained on study for assessmen t of response, safety and overall survival. TEAEs leading to withdrawal of vaccination will be summarised descriptively . Patients will be included if an AE has “Action taken” recorded as “Drug Withdrawn” or “Did the AE cause the subject to be discontinued from the study?” is recorded as yes. All TEAEs and related TEAEs by worst CTCAE grade within an episode will be presented by number of TEAEs and by numbe r of patients (see Table 10 and Table 11, respectively ). SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 18 Table 10: Frequency of Treatment Emergent A dverse Event s and Related Treatment Emergent Adverse Events by Worst CTCAE Grade within an Episode (Safety Population) SYSTEM ORGAN CLASS Preferred Term All TEAEs AST-VAC2 Related TEAEs _______Grade______ _______Grade______ Total 1 2 3 4 5 Total 1 2 3 4 5 Overall total N N N N N N N N N N N N BLOOD AND LYMPHATIC… Anaemia CARDIAC DISORDERS Sinus tachycardia Etc Table 11: Frequency of Patients with Treatment Emergent A dverse Event s and Related Treatment Emergent Adverse Events by Worst CTCAE Grade within an Episode (Safety Population) SYSTEM ORGAN CLASS Preferred Term All TEAEs AST-VAC2 Related TEAEs No. of patients with > =1 AE (N=XX) No. of patients with >=1 AE (N=XX) _______Grade______ _______Grade______ Total 1 2 3 4 5 Total 1 2 3 4 5 Overall total N (%) N N N N N N (%) N N N N N BLOOD AND LYMPHATIC… Anaemia CARDIAC DISORDERS Sinus tachycardia Etc 5.8 Laboratory results Laboratory results (haematology, biochemistry and urinalysis) will be presented in data listings as an appendix to the CSR. Any significant out of range values are captured as AEs and will be presented in the summary AE tables (see Section 5.7). 5.8.1 Additional safety tables A table of ISR grade by vaccination number will be produced. SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 19 Table 1 2: Summary of I njection Site Reactions by Grade and Vaccination Number (Safety Population) ISR Grade Vaccination number at onset Total 1 2 3 4 5 6 1 N N N N N N N 2 3 4 5 5.8.2 Stopping rule criteria Any AEs that meet the stopping rule criteria will be presented descriptively. 5.9 Efficacy Documentation of tumour response is a secondary o bjective of this trial. A nti-tumour activity will be measured according to the modified irRC; (see Protocol Appendix 3 ) at 30 days (+/- 5 days) after the last AST-VAC2 vaccination in all patients . The overall response will be presented for the ‘Response Population’ (see Table 13). The response rate is defined as the ratio of patients with any response ( immune -related complete response [ irCR] or immune -related partial response [ irPR]) to the total number of patients included in the efficacy population. Overall survival will be assessed in the ‘Safety Po pulation’ and is defined as the time from the first AST-VAC2 vaccination to the date of death (regardless of whether the patient went on to receive other anti-cancer treatments) or date of last contact (if patient is still alive or lost to follow -up). Survival will be summarised for each patient as shown in Table 14.