Processes | Clinical | AE Narrative

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:
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.