Management of Analysis Data 7.3.1. Missing Data In general, there will be no substitutions made to accommodate missing data points. All data recorded on the electronic case report form ( e-CRF) will be included in data listings that will accompany the clinical study report. 7.3.1.1. Handling of Missing Date Value s Partial or Missing Dates The following conventions will be used to impute missing portions of dates for adverse events and concomitant medications , if warranted . Note that the imputed values outlined here may not always provide the most conservative dat e. In those circumstances, the imputed value may be replaced by a date that will lead to a more conservative analysis. A. Start Dates 1) If the year is unknown, then the date will not be imputed and will be assigned a missing value. 2) If the month is un known, then: i) If the year matches the first dose date year, then impute the month and day of the first dose date. ii) Otherwise, assign ‘January.‘ 3) If the day is unknown, then: i) If the month and year match the first dose date month and year, then impute the day of the first dose date. ii) Otherwise, assign the first day of the month. B. Stop Dates 1) If the year is unknown, then the date will not be imputed and will be assigned a missing value. 2) If the month is unknown, then assign ‘December .’ 3) If the day is unknown, then assign the last day of the month. OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 23/51 Unless having an end date before the first administration of the study drug, an adverse event with a completely missing start date will be interpreted as started between the first dose dat e included and 28 days after last administration of the study treatment (included) or the analysis cut-off date included, whichever comes first. No imputation should be used for the start date of immune -related adverse events recorded in medical history (M H2 VIEDOC dataset). A medication with a completely missing start date will be interpreted as started before the first dose date. A medication with a completely missing end date will be interpreted as ongoing at the time of data extraction (and therefore be ing not stopped before the first dose). 7.3.1.2. Imputation Methods No safety or efficacy data will be imputed for this study. All data will be observed cases, without imputation , except specified otherwise (as for time to worsening of ECOG or quality of life sensitivity analyses as examples) . 7.3.2. Coding Conventions for Events and Medications All adverse events, and medical history will be mapped to the Medical Dictionary for Regulatory Activities (MedDRA Version 20.1) system for reporting (preferred term and body system). Prior and Concomitant medications will be coded using WHO -DD (Drug Dictionary) (Version March 2018) . 7.3.3. Analysis Software Data manipulation, tabulation of descriptive statistics, calculation of inferential statistics, and graphical representations wi ll be performed primarily using SAS (release 9.4 or higher) for Windows. If the use of other software is warranted, the final clinical study report will detail what software was used and for what purposes. 7.3.4. Study Data Study data identified in the schedule for time and events in the Protocol are collected, and source verified, on the electronic data capture tool: VIEDOC (PCG Solutions, Uppsala, Sweden ). All study data will be formulated into regulatory compliant data sets to provide transparency, traceability, and integrity of trial analysis results from the collection source. Observed study data will be mapped to the CDISC Study Data Tabulation Model (SD TM) and serve as the OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 24/51 source data from the trial. All study analyses will be completed using analysis data sets that are derived from the SDTM and follow the CDISC Analysis Data Model (ADaM) architecture. The methods for programming the CDISC SDTM and ADa M data sets are described in Figure 1. Figure 1 SDTM, ADaM, and TFL Development and Validation Where: 1. Development, Validation, and Maintenance of SDTM Domains 2. Development and Validation of Analysis Data Sets (ADaM), with input so urce the appropriate SDTM domains. 3. Development and Validation of Tables, Figures, and Listings (TFL), with input data source the SDTM domains and analysis specific ADaM data sets. 7.4.