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• Any variable copied unchanged from ADSL
• Any variable copied unchanged from SDTM AE
  • SubClass ADVERSE EVENT should include all SDTM AE variables with the SDTM core value of Required or Expected.
• Any variable copied or derived from SDTM FA (see ADD LINK Section 9, Example 6: Analysis of Adverse Events that Change over Time)
  • When FA is used as input to the ADVERSE EVENT SubClass dataset, a unique identifier variable, such as FASEQ or FASPID, is required for traceability.
• Any variable copied from content in SDTM SUPPAE
  • It is recommended to use SUPPAE QNAM as the ADVERSE EVENT SubClass dataset variable name, SUPPAE QLABEL as the ADVERSE EVENT SubClass dataset variable label, and SUPPAE QVAL as the ADVERSE EVENT SubClass variable content.
• Derived variables, such as numeric timing variables, TRTEMFL and other indicators, analysis versions of descriptive variables, and other variables derived using the naming conventions described in ADD LINK Section 3.2.11, User-specified Variable Naming Conventions