Samples / GLPI-103 / regulatory/m5-clinical/define/ARM-301_analysis_results_metadata.md

Analysis Results Metadata (ARM) — GLPI103-301

Field Value
Document ID ARM-301
Version 1.0
Status Final (portfolio)
Standards CDISC Analysis Results Metadata (ARM) for Define-XML; ADaM
Companion to define.xml, ADRG (DEF-301), SAP-301, SAR-301
Confidentiality Confidential — portfolio use

Analysis Results Metadata provides end-to-end traceability for every key analysis result: from the reported display back to the analysis dataset, the population/selection, the statistical method, the executing program, and the output file. This is the metadata layer a regulatory reviewer uses to reproduce a result.

Change History

Version Date Author Summary
1.0 2026-06-30 Biostatistics Initial — covers primary, estimand, missing-data, multiplicity, responder, subgroup, time-to-event, and hepatic results

Analysis Datasets (ADaM)

Dataset Class Structure Key analysis use
ADSL ADSL One record/subject Populations, treatment, strata, disposition, ICE flags
ADLB BDS One record/param/visit/subject HbA1c & lab CFB (ANCOVA, MMRM, estimands, MI)
ADAE OCCDS One record/AE/subject TEAE incidence, SAEs, AESI
ADVS BDS One record/param/visit/subject Vital-sign & weight CFB
ADTTE BDS One record/param/subject Time-to-event (rescue, target)

Analysis Results

Result ID Display / Result Dataset Population / Selection Method Program Output
R-EFF-01 Primary: HbA1c CFB at Wk 52, LS-mean diff vs Sema ADLB FAS; PARAMCD=HBA1C; VISITNUM=8 ANCOVA CHG ~ TRT01A + BASE + STRAT_HBA1C + STRAT_BMI run_analysis.R ancova_results.csv
R-EFF-02 Primary estimands (treatment-policy, hypothetical) ADLB + ADSL FAS; visits W4–52 MMRM (mmrm, unstructured, Kenward-Roger); ICE strategies mmrm_estimands.R estimand_results.csv
R-EFF-03 Longitudinal HbA1c by visit ADLB FAS; visits W4–52 MMRM LS means by visit run_analysis.R mmrm_results.csv
R-SENS-01 Missing-data sensitivity (MAR/JR/CR) ADLB + ADSL FAS; complete visit grid Reference-based MI (rbmi), Rubin's rules missing_data_sensitivity.R missing_data_results.csv
R-SENS-02 Tipping-point (MNAR delta) ADLB + ADSL FAS; IV vs Sema Delta-adjusted MI missing_data_sensitivity.R missing_data_results.csv
R-MULT-01 Fixed-sequence multiplicity decisions (8 steps) ADLB + ADSL FAS Hierarchical gatekeeping (α=0.05) secondary_subgroup.py multiplicity_results.csv
R-SEC-01 Responders (HbA1c<7%, ≥10% weight) ADLB + ADSL FAS; NRI Logistic regression + stratified CMH secondary_subgroup.py responder_results.csv
R-SEC-02 Subgroup HbA1c effect + interaction ADLB + ADSL FAS; IV vs Sema ANCOVA within subgroup + interaction F-test secondary_subgroup.py subgroup_results.csv
R-TTE-01 Time to HbA1c<7% / time to rescue (HR) ADTTE FAS Kaplan-Meier + stratified Cox PH survival_recurrent.R survival_results.csv
R-SAF-01 Recurrent hypoglycaemia rate ratio ADAE + ADSL Safety; exposure offset Quasi-Poisson rate model survival_recurrent.R recurrent_results.csv
R-SAF-02 Hepatic safety (eDISH / Hy's law) ADLB-source (ALT, bilirubin) Safety; per-subject peaks eDISH quadrant + Hy's-law flag hepatic_safety.py hepatic_edish.csv, figure4_edish
R-EFF-04 Bayesian primary (posterior P(superiority)) ADLB FAS Bayesian ANCOVA (conjugate normal) bayesian_exposure.py bayesian_results.csv
R-EFF-05 Exposure–response (HbA1c vs dose) Phase 2 dose-finding dose-finding Emax model bayesian_exposure.py exposure_response.csv

Quality Control — Double Programming

QC ID Result qualified Independent method Program Output
QC-DP-01 R-EFF-01 primary contrasts (both arms) Independent Python ANCOVA (statsmodels) reproduces R emmeans within ±0.01 qc_double_program.py qc_double_program.csv

All results are regenerated reproducibly by python build.py --stage biostat; every reconciled CSR number is checked by tools/reconcile_csr.py.