# ADaM Define.xml Documentation Report

## File Metadata
- **Define-XML Version**: 2.0
- **ODM Schema Version**: 1.3.2
- **Source File**: 05_adam/define.xml

## Dataset Inventory
| Dataset | Label | Class | Records |
|---------|-------|-------|---------|
| ADSL | Subject-Level Analysis | ADSL | 254 |
| ADAE | Adverse Events Analysis | OCCDS | 1,191 |
| ADADAS | ADAS-Cog Analysis | BDS | 2,718 |
| ADLBC | Laboratory Analysis | BDS | 7,778 |
| ADTTE | Time-to-Event Analysis | ADTTE | 254 |

## Key Analysis Variable Definitions
- **TRT01PN**: Planned Treatment (Numeric) - 0/54/81 mapping
- **ITTFL/SAFFL/EFFFL**: Population flags with explicit derivation rules
- **PARAMCD**: Analysis parameter codes per ADaM structure
- **AVAL/BASE/CHG/PCHG**: Analysis value chain per BDS standard

## Codelist Count
- **Total**: 894 codelists (P21 format with ARC extensions)

## Computational Methods
- ANCOVA model specification referenced for primary endpoint
- LOCF imputation method documented in ADADAS derivation
- Treatment-emergent flag logic documented in ADAE derivation

## Primary Endpoint Lineage (ADADAS.ACTOT)
1. Source: QS domain (CDISC SDTM)
2. Parameter: PARAMCD = 'ACTOT' (sum of 11 ADAS-Cog items)
3. Derivation: AVAL = sum of ACITM01-ACITM11 responses
4. Baseline: BASE = AVAL at AVISITN = 0
5. Change: CHG = AVAL - BASE
6. LOCF: DTYPE = 'LOCF' for post-baseline imputed records
7. Analysis flag: ANL01FL = 'Y' for included observations

## Compliance Standards
- ADaM Implementation Guide: 1.1
- Define-XML: 2.0
- ODM Schema: 1.3.2 (Note: differs from SDTM define.xml v1.2.2)
