Patients will only be included in the missing and total categor ies if they attended the visit but have no data available for that parameter. P atients 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 . Individual patient haematology values up to 1 year after first dose of IMP will be plotted, with separate pages for each group and parameter. Additionally, box plots will be produced to summarize values over time, with separate pages for each group and parameter. Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 15 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 All haematology values wi ll be listed s howing reference ranges and flagging all abnormal findings and their clinical significance. Out of reference range values will be flagged as high (H) or low (L) . 5.4.2 Biochemistry including INR Biochemistry and INR values will be summarised by parameter and visit, including change from baseline and percent change from baseline. The number and percentage of patients with low (clinically significant), low ( not clinically significant) , normal, high (not clinically significant), high (clinically significant) , missing and total results based on reference ranges will be summarised by parameter and visit . Patients will only be included in the missing and total categor ies if they attended the visit but have no data available for that parameter. P atients 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 . Individual patient biochemistry values up to 1 year after first dose of IMP will be plotted, with separate figures for each group and parameter. Additionally, box plots will be produced to summarize values over time, with separate pages for each group and parameter. All bio chemistry value s will be listed s howing reference ranges and flagging all abnormal findings and their clinical significance. Out of reference range values will be flagged as high (H) or low (L) . 5.4.3 Urinalysis All urinalysis dipstick results will be listed . 5.5 Vital Signs Vital signs include weight, pulse rate, systolic blood pressure, diastolic blood pressure and body temperature. Vital sign values will be summarised by parameter and visit, including change from baseline and percent change from baseline. For each parameter, the baseline value will be defined as the last scheduled or unscheduled value collected prior to first dose of IMP. Assessments carried out on day of first IMP administration are considered to have taken place before the IMP administration, if t he corresponding times have not been recorded. For post baseline, only data from scheduled visits will be included in the t able. Percent change from baseline will be calculated as 100 * (observed value – baseline value) / baseline value. All vital signs va lues will be listed, flagging any unscheduled assessments. 5.6 Electrocardiogram (ECG ) All ECG data will be listed, flagging any unscheduled ECG assessments . 5.7 Physical Examination and Eastern Cooperative Oncology Group ( ECOG) Performance Status The number and percentage of patients by ECOG status and visit will be tabulated and a shift table will present shift from baseline in ECOG status by visit. The baseline value will be defined as the last scheduled or unscheduled value collected prior to first Syne qua non study no: TAX12001 Targovax ASA study no: CT TG01 -01 Date: 02MAY2018 Page 16 of 21 Version: Amendment 1.0 Final 1.0 ST/form/010/10 dose of IMP .