# Data Dictionary - Beyond TLG Generation

**Version 1.0.0 - 24 September 2026**

This dictionary describes the compact CSV files released with the Planimeter TLG reporting demonstration.

## `data/adlb_analysis.csv`

A compact ADLB-like laboratory analysis dataset derived from Pharmaverse demonstration data. The file has 9,079 rows and 27 variables.

| Variable | Description |
|---|---|
| `STUDYID` | Demonstration study identifier. |
| `USUBJID` | Unique subject identifier. |
| `PARAMCD` | Laboratory parameter code; restricted here to ALT, AST, BILI, CREAT and HGB. |
| `PARAM` | Laboratory parameter description with standard unit text. |
| `ADT` | Analysis date derived from SDTM-style laboratory date. |
| `VISIT` | Visit label. |
| `VISITNUM` | Numeric visit value from the source laboratory data. |
| `AVAL` | Numeric laboratory analysis value in the source standard unit. |
| `LBSTRESU` | Standard unit from the source LB data. |
| `LBSTNRLO` | Lower reference-range limit. |
| `LBSTNRHI` | Upper reference-range limit. |
| `LBNRIND` | Source normal-range indicator. |
| `TRT01P` | Planned treatment from the subject-level demonstration dataset. |
| `TRT01A` | Actual treatment. |
| `TRTSDT` | Treatment start date. |
| `TRTEDT` | Treatment end date. |
| `SAFFL` | Safety-population flag. |
| `ADY` | Analysis day relative to treatment start date. |
| `BASE` | Baseline laboratory value: last non-missing value on or before treatment start date. |
| `BASEDT` | Date associated with `BASE`. |
| `ABLFL` | Baseline-row flag (`Y`). |
| `CHG` | Change from baseline, `AVAL - BASE`. |
| `PCHG` | Percent change from baseline, `100 * (AVAL - BASE) / BASE`, when baseline is non-zero. |
| `POSTBLFL` | Post-baseline flag (`Y`) for dates strictly after treatment start date. |
| `ANL01FL` | Analysis flag (`Y`) for non-missing `AVAL`. |
| `ANRIND` | Derived range category: `LOW`, `NORMAL` or `HIGH` based on reference limits. |
| `PARAMN` | Numeric ordering variable for the five retained laboratory parameters. |

### Important scope note

The file is intentionally described as **ADLB-like**. It is a compact teaching derivation and is not presented as a submission-ready ADaM dataset.

## `data/alt_shell_input.csv`

Long-format data used to populate the ALT shell example. It contains 665 rows.

| Variable | Description |
|---|---|
| `USUBJID` | Unique subject identifier. |
| `TRT01P` | Planned treatment arm. |
| `VISIT` | One of `Baseline`, `Week 4`, or `Week 8`. |
| `VALUE` | Baseline ALT value for Baseline rows; change from baseline for Week 4 and Week 8 rows. |

Unique subject counts are 86 Placebo, 84 Xanomeline Low Dose and 84 Xanomeline High Dose. The longitudinal row counts are larger and must not be used as column subject N values.

## `data/lab_shift_input.csv`

Subject-by-parameter input for the baseline-to-worst-post-baseline shift table. It contains 1,234 unique subject-parameter rows.

| Variable | Description |
|---|---|
| `USUBJID` | Unique subject identifier. |
| `TRT01P` | Planned treatment arm. |
| `PARAMCD` | Laboratory parameter code. |
| `BASECAT` | Baseline range category: `LOW`, `NORMAL`, or `HIGH`. |
| `WORSTCAT` | Selected post-baseline range category under the demonstration ranking. |

The development workflow ranks `HIGH > LOW > NORMAL` when selecting a single post-baseline category. That ranking is illustrative and should not be treated as a clinically universal severity ordering.

## `reference/tlg_release_summary.csv`

Compact counts produced by the release-input export run, including source-row counts and derived-data dimensions.

## `reference/table_shell_alt_change.txt`

Human-readable table shell defining the intended ALT output structure, statistics, decimal precision and footnotes before the table is populated.

## `reference/table_01_populated_shell_alt_change.txt`

Development `rtables` output supplied for release preparation. Its cell-level statistics are valid, but the original column `N` values are longitudinal record counts rather than unique-subject counts. The cleaned release code corrects this presentation issue.

## `reference/table_02_baseline_laboratory_values.txt`

Development `rtables` baseline laboratory summary by treatment arm and laboratory parameter.

## `reference/table_03_laboratory_shift_table.txt`

Development `rtables` baseline-to-worst-post-baseline laboratory shift table.

## `reference/table_04_abnormality_listing.csv`

Thirty high post-baseline laboratory records ranked by amount above the upper reference limit (`Above_ULN`).

## `output/validation_checks.csv`

Automated release checks performed independently from the original R execution. `PASS` indicates agreement with the supplied data and reference outputs.

## `output/release_qa_notes.csv`

Documents release-time QA findings and how they are handled in version 1.0.0.