ADaM Dataset Specification — GLPI103-301
| Field |
Value |
| Document ID |
ADaM-SPEC-301 |
| Version |
1.0 |
| Study No. |
GLPI103-301 |
| Standard |
CDISC ADaMIG v1.x; Define-XML 2.1 |
| Confidentiality |
Confidential |
Variable-level specification for the analysis datasets, matching src/cdisc/adam_builder.py, define.xml, and the ADRG (DEF-301).
Change History
| Version |
Date |
Author |
Summary |
| 1.0 |
2026-06-29 |
Biostatistics / DM |
Initial ADaM spec |
ADSL — Subject-Level Analysis Dataset (one record per subject; N=900)
| Variable |
Label |
Type |
Source / Derivation |
| STUDYID |
Study Identifier |
Char |
GLPI103 |
| USUBJID |
Unique Subject ID |
Char |
STUDYID-SITEID-SUBJID |
| SUBJID, SITEID |
Subject/Site ID |
Char |
DM |
| AGE |
Age (yr) |
Num |
DM |
| AGEGR1 |
Age group |
Char |
<65 / >=65 |
| SEX, RACE, COUNTRY |
Demographics |
Char |
DM |
| TRT01P / TRT01A |
Planned / Actual treatment |
Char |
DM ARM / ACTARM |
| TRT01PN / TRT01AN |
Treatment (numeric) |
Num |
1=IV, 2=Oral, 3=Sema |
| RANDDT |
Randomization date |
Char |
DM RFSTDTC |
| FASFL / SAFFL |
FAS / Safety flags |
Char |
"Y" (all randomized/dosed) |
| PPSFL |
Per-protocol flag |
Char |
"Y"/"N" — derived from DEVFL (major deviation); PPS=847, FAS=900 |
| STRAT_HBA1C |
HbA1c stratum |
Char |
<8.5/>=8.5 from baseline HbA1c (IRT) |
| STRAT_BMI |
BMI stratum |
Char |
<30/>=30 from baseline BMI |
| STRAT_REGION / REGION |
Region stratum |
Char |
Province→region group |
| EDUCATION / MARITAL / EMPLOYMENT |
Baseline covariates |
Char |
SC domain (English CT) |
ADLB — Laboratory Analysis Dataset (BDS; one record per parameter/visit/subject)
| Variable |
Label |
Type |
Source / Derivation |
| STUDYID, USUBJID |
Identifiers |
Char |
— |
| TRT01A / TRT01AN |
Treatment |
Char/Num |
ADSL |
| FASFL/PPSFL/SAFFL |
Population flags |
Char |
ADSL |
| PARAMCD / PARAM |
Parameter (code/name) |
Char |
LB (HBA1C, FPG, ALT, AST, EGFR) |
| AVAL / AVALU |
Analysis value / unit |
Num/Char |
LB LBSTRESN |
| BASE |
Baseline value |
Num |
AVAL where ABLFL="Y" |
| CHG / PCHG |
Change / % change from baseline |
Num |
AVAL−BASE / CHG/BASE×100 |
| ABLFL |
Baseline flag |
Char |
"Y" at VISITNUM=1 |
| ANL01FL |
Analysis flag |
Char |
"Y" for non-baseline visits |
| VISITNUM / VISIT |
Visit |
Num/Char |
1–9 (W0–W56) |
| STRAT_HBA1C/STRAT_BMI, AGE, AGEGR1, SEX |
Analysis covariates |
— |
ADSL |
Additional analysis datasets in a full submission: ADAE (adverse events), ADVS (vital signs), ADTTE (time-to-event, if any). Their specs follow the same conventions.