Listing 2: TEAEs by SOC/PT

Listing — TEAEs by SOC / PT

This listing provides subject-level TEAE detail organized by MedDRA SOC → PT, with full traceability (programs → outputs).

Deliverables

• Program: Generate Listing
• Output: Listing Output (HTML)

Traceability

Listing → ADAE → SDTM AE → Source

Display conventions

• Population: SAF
• TEAE rule: On/after first dose (per protocol definition documented in footnote)
• Sort (recommended): TRT01A → AEBODSYS → AEDECOD → USUBJID → ASTDT/ASTDTM

Key columns (typical)

USUBJID, TRT01A, AEBODSYS, AEDECOD, AETERM, ASTDT/ASTDTM, AENDT/AENDTM, AESEV, AESER, AEREL, AEACN, AEOUT, TRTEMFL