ADaM ADAE (Adverse Events Analysis Dataset)

Analysis-ready event-level ADaM dataset derived from SDTM AE (and ADSL) to support treatment-emergent adverse event (TEAE) analyses, including analysis dates, severity/seriousness, relationship, and analysis flags used for summary tables and listings.

Deliverables

Specifications

• ADAE Specifications

Programming

• Build ADAE (R Derivation Program)

What you’ll find here

• Purpose: Event-level AE records aligned to analysis populations and treatment periods
• Traceability: Spec → Program → Output alignment (including merges to ADSL)
• Typical variables: STUDYID, USUBJID, AEDECOD, AEBODSYS, AESER, AESEV, AEREL, ASTDT, AENDT, ASTDY, AENDY, treatment variables from ADSL (e.g., TRT01A), and flags like TRTEMFL / TEAEFL