ADSL Subject-Level Analysis Dataset: Derivation Rules & Keys

Why ADSL Subject-Level Architecture Matters in Clinical Submissions

Every BDS analysis dataset (ADAE, ADLB, ADVS, ADTTE) merges with ADSL to inherit treatment arms, baseline covariates, and safety flags.

Standard Syntax, Derivation & Framework Pattern

/* Building Key Baseline Flags in ADSL */
DATA adam.adsl;
    SET sdtm.dm;
    
    /* Standard Character & Numeric Treatment Variables */
    IF ARM = 'Drug X 50mg' THEN TRT01PN = 1;
    ELSE IF ARM = 'Drug X 100mg' THEN TRT01PN = 2;
    ELSE IF ARM = 'Placebo' THEN TRT01PN = 3;
    TRT01P = ARM;
    
    /* Age Group Categorization */
    LENGTH AGEGR1 $20;
    IF AGE < 65 THEN AGEGR1 = '<65 years';
    ELSE IF AGE >= 65 THEN AGEGR1 = '>=65 years';
    
    /* Intent-to-Treat & Safety Population Flags */
    IF ARM NE 'Screen Failure' THEN ITTFL = 'Y';
    ELSE ITTFL = 'N';
RUN;

Core Rules & Certification Takeaways

• ADSL has exactly one observation per subject (USUBJID is the primary unique sorting key).
• Contains paired character and numeric variables for treatment (TRT01P / TRT01PN) and stratification factors.
• Stores master dates: TRTSDT (Treatment Start Date), TRTEDT (Treatment End Date), and TRTDURD (Treatment Duration in Days).
• Acts as the denominator donor for calculating incidence percentages in AE and Safety tables.

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