AE Narrative

This process is used to generate AE narratives for clinical study reports.

What do I need?

This process requires several demographic-, electrocardiogram -, laboratory-, and/or vital sign -related variables . These include:

•

USUBJID ,

•	the description of the planned treatment arm ( ARM ), AGE , SEX , RACE , SITEID , and reference start date and time ( RFSTDTC )

•

from the AE domain: Action taken with study treatment ( AEACN ), Dictionary Derived Term ( AEDECOD ), End Date/Time of Adverse Event ( AEENDTC ), AE Outcome ( AEOUT ), Causality ( AEREL ), Serious Event ( AESER ), Severity/Intensity ( AESEV ), Start Date/Time of Adverse Event ( AESTDTC ) and Reported Term for Adverse Event ( AETERM )

•	from the CM domain: Standardized Medication Name ( CMDECOD ), Start Date/Time of Medication ( CMSTDTC ), End Date/Time Medication ( CMENDTC ) and Reported Name of Drug, Medicine, or Therapy ( CMTRT )

•	from the DS domain: Category for Disposition Event ( DSCAT ), Standardized Disposition Term ( DSDECOD ), Start Date/Time of Disposition Event ( DSSTDTC ) and Reported Term for Disposition Event ( DSTERM )

•	from the EX domain: Dose per Administration ( EXDOSE ), Dose Units ( EXDOSU ), Start Date/Time of Treatment ( EXSTDTC ), End Date/Time of Treatment ( EXENDTC ) and Name of Actual Treatment ( EXTRT )

•	from the MH domain: Start Date/Time of Medical History Event ( MHSTDTC ) and Reported Term for the Medical History ( MHTERM )

Variables can be taken either from the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) folder or from AE , DM , CM , DS , EX , and MH domains in SDTM . Refer to Localization-Specific Value Specification for more information about these data sets.

Output/Results

The output generated by this process is summarized in a tabbed report. Refer to the AE Narrative output documentation for detailed descriptions and guides to interpreting your results.