Listing 1: Demographics & Baseline (Analysis Set)

Listing 1: Subject Demographics & Baseline Characteristics (Analysis Set)

This listing provides subject-level demographics and baseline characteristics for the analysis population, supporting review, QC, and traceability (programs → outputs).

Deliverables

• Program: Generate Listing 1
• Output: Listing 1 Output (HTML)

Traceability

Listing → ADSL → SDTM DM → Source

Display conventions

• Population: ITT / SAF / PP (as defined for this listing)
• One record per subject
• Sort (recommended): TRT01A → SITEID → USUBJID

Key columns (typical)

• Identifiers: STUDYID, SITEID, USUBJID
• Treatment: TRT01A, TRT01P
• Population flags: ITTFL, SAFFL, PPFL
• Demographics: AGE, AGEU, SEX, RACE, ETHNIC
• Baseline characteristics (examples): HEIGHTBL, WEIGHTBL, BMIBL, REGION, COUNTRY
• Key dates: RFSTDTC, RFENDTC

Notes

• Baseline values reflect pre-treatment (per protocol definition) and are documented in the program/output footnote.
• If derived variables are displayed (e.g., BMI), include derivation notes in the listing footnote for reviewer clarity.