SDTM AE (Adverse Events)

Core event-level SDTM domain built from raw safety sources to define one record per adverse event occurrence per subject, capturing the reported term (and coded term when available), event start/end dates, and key qualifiers such as severity, seriousness, relationship to treatment, action taken, and outcome, supporting downstream safety summaries and listings.

Deliverables

Specifications

• AE Specifications

Programming

• AE Build Program (R)

What you’ll find here

• Purpose: One record per AE per subject (event timing + clinical qualifiers)
• Traceability: Spec → Program → Output alignment (mappings, derivations, controlled terminology)
• Typical variables: STUDYID, DOMAIN, USUBJID, AESEQ, AETERM, AEDECOD, AEBODSYS, AESOC, AESEV, AESER, AEREL, AEACN, AEOUT, AESTDTC, AEENDTC, AESTDY, AEENDY, AEENRF, AEPRESP, AESDTH, AESLIFE, AESDISAB, AESHOSP, AESCONG