The median OS will be presented. Categorical variables will be summarised in frequency tables. Percentages in the summary tables will be rounded and may therefore not always add up to exactly 100%. The convention in Rave is that an unknown day resolves to 1st of the month and an unknown month resolves to January. Dates may be ordered by this ; however , CRUK do not perform calculations on unknown dates except as stated below. Durations of AEs: the start date of an AE is considered as Day 1 of the event and should be included in all duration calculations (i.e. if an AE starts and stops on same day, the duration should be reported as one day). - For unrelated AEs, those with missing or partially completed end dates will not be excluded from analysis and the duration of the AE will be calculated from the first day of the month (if unknown) or first day of the year (based on RAVE conventions) . - For related AEs, prior to final data lock, an end date will be either i) confirmed AE end date or ii) stabilisation of AE. Cases where this is not possible are if the patient was lost to follow up . If lost to follow -up then the AE would stay as not recovered/not resolved. In this case duration would not be calculated. Time to onset of AEs from IMP administration: the time to onset should be calculated from the date of the first AST -VAC2 vaccination and AEs occurring within a specific vaccination window (e.g. start date from date of 2 nd vaccination to before date of 3rd vaccination) should also have times to onset calculated from the date of the last vaccination administered in that window (e.g. Vaccination 2) . Onset time will be SM.TEMP.013 version 5 CRUKD/17/003 RAP Version: 2.0 09Mar2023 FINAL 21 calculated as 0 if the AE occur s on the same day as the dose ; however , if the start time is missing, onset time will not be calculated (only applicable when the drug admin has a start time entered) . AE assignment: AE is assigned to the vaccination number it begins in .