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Variables that describe the record are often used in analysis. Include these and any other SDTM variables if used in analysis. If the analysis version of the variable differs from the version in the SDTM, additional variables must be added using the conventions below and described in ADD LINK Section 2.9.3.2, Variable Metadata., How to Create Analysis Variables.

The following table lists some common descriptive variables that are often included in ADAE. Any other SDTM variables should be included as appropriate (e.g. AEOUT, AESDTH).

Adverse Event Descriptive Variables

Medical history data typically does not contain descriptive variables. If needed for analysis, use variables as shown above for adverse events, replacing the prefix “AE” with “MH”.

Concomitant Medications Descriptive Variables