CO |
Comments |
Special Purpose |
One record per comment per subject |
Tabulation |
STUDYID, USUBJID, IDVAR, COREF, CODTC |
co.xpt |
DM |
Demographics |
Special Purpose |
One record per subject |
Tabulation |
STUDYID, USUBJID |
dm.xpt |
SE |
Subject Elements |
Special Purpose |
One record per actual Element per subject |
Tabulation |
STUDYID, USUBJID, ETCD, SESTDTC |
se.xpt |
SM |
Subject Disease Milestones |
Special Purpose |
One record per Disease Milestone per subject |
Tabulation |
STUDYID, USUBJID, MIDS |
sm.xpt |
SV |
Subject Visits |
Special Purpose |
One record per subject per actual visit |
Tabulation |
STUDYID, USUBJID, VISITNUM |
sv.xpt |
AG |
Procedure Agents |
Interventions |
One record per recorded intervention occurrence per subject |
Tabulation |
STUDYID, USUBJID, AGTRT, AGSTDTC |
ag.xpt |
CM |
Concomitant/Prior Medications |
Interventions |
One record per recorded intervention occurrence or constant-dosing interval per subject |
Tabulation |
STUDYID, USUBJID, CMTRT, CMSTDTC |
cm.xpt |
EC |
Exposure as Collected |
Interventions |
One record per protocol-specified study treatment, collected-dosing interval, per subject, per mood |
Tabulation |
STUDYID, USUBJID, ECTRT, ECSTDTC, ECMOOD |
ec.xpt |
EX |
Exposure |
Interventions |
One record per protocol-specified study treatment, constant-dosing interval, per subject |
Tabulation |
STUDYID, USUBJID, EXTRT, EXSTDTC |
ex.xpt |
ML |
Meal Data |
Interventions |
One record per food product occurrence or constant intake interval per subject |
Tabulation |
STUDYID, USUBJID, MLTRT, MLSTDTC |
ml.xpt |
PR |
Procedures |
Interventions |
One record per recorded procedure per occurrence per subject |
Tabulation |
STUDYID, USUBJID, PRTRT, PRSTDTC |
pr.xpt |
SU |
Substance Use |
Interventions |
One record per substance type per reported occurrence per subject |
Tabulation |
STUDYID, USUBJID, SUTRT, SUSTDTC |
su.xpt |
AE |
Adverse Events |
Events |
One record per adverse event per subject |
Tabulation |
STUDYID, USUBJID, AEDECOD, AESTDTC |
ae.xpt |
CE |
Clinical Events |
Events |
One record per event per subject |
Tabulation |
STUDYID, USUBJID, CETERM, CESTDTC |
ce.xpt |
DS |
Disposition |
Events |
One record per disposition status or protocol milestone per subject |
Tabulation |
STUDYID, USUBJID, DSDECOD, DSSTDTC |
ds.xpt |
DV |
Protocol Deviations |
Events |
One record per protocol deviation per subject |
Tabulation |
STUDYID, USUBJID, DVTERM, DVSTDTC |
dv.xpt |
HO |
Healthcare Encounters |
Events |
One record per healthcare encounter per subject |
Tabulation |
STUDYID, USUBJID, HOTERM, HOSTDTC |
ho.xpt |
MH |
Medical History |
Events |
One record per medical history event per subject |
Tabulation |
STUDYID, USUBJID, MHDECOD |
mh.xpt |
CV |
Cardiovascular System Findings |
Findings |
One record per finding or result per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, VISITNUM, CVTESTCD, CVTPTREF, CVTPTNUM |
cv.xpt |
DA |
Drug Accountability |
Findings |
One record per drug accountability finding per subject |
Tabulation |
STUDYID, USUBJID, DATESTCD, DADTC |
da.xpt |
DD |
Death Details |
Findings |
One record per finding per subject |
Tabulation |
STUDYID, USUBJID, DDTESTCD, DDDTC |
dd.xpt |
EG |
ECG Test Results |
Findings |
One record per ECG observation per replicate per time point or one record per ECG observation per beat per visit per subject |
Tabulation |
STUDYID, USUBJID, EGTESTCD, VISITNUM, EGTPTREF, EGTPTNUM |
eg.xpt |
FA |
Findings About Events or Interventions |
Findings |
One record per finding, per object, per time point, per visit per subject |
Tabulation |
STUDYID, USUBJID, FATESTCD, FAOBJ, VISITNUM, FATPTREF, FATPTNUM |
fa.xpt |
FT |
Functional Tests |
Findings |
One record per Functional Test finding per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, TESTCD, VISITNUM, FTTPTREF, FTTPTNUM |
ft.xpt |
IE |
Inclusion/Exclusion Criteria Not Met |
Findings |
One record per inclusion/exclusion criterion not met per subject |
Tabulation |
STUDYID, USUBJID, IETESTCD |
ie.xpt |
IS |
Immunogenicity Specimen Assessments |
Findings |
One record per test per visit per subject |
Tabulation |
STUDYID, USUBJID, ISTESTCD, VISITNUM |
is.xpt |
LB |
Laboratory Test Results |
Findings |
One record per lab test per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, LBTESTCD, LBSPEC, VISITNUM, LBTPTREF, LBTPTNUM |
lb.xpt |
MB |
Microbiology Specimen |
Findings |
One record per microbiology specimen finding per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, MBTESTCD, VISITNUM, MBTPTREF, MBTPTNUM |
mb.xpt |
MI |
Microscopic Findings |
Findings |
One record per finding per specimen per subject |
Tabulation |
STUDYID, USUBJID, MISPEC, MITESTCD |
mi.xpt |
MK |
Musculoskeletal System Findings |
Findings |
One record per assessment per visit per subject |
Tabulation |
STUDYID, USUBJID, VISITNUM, MKTESTCD, MKLOC, MKLAT |
mk.xpt |
MO |
Morphology |
Findings |
One record per Morphology finding per location per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, VISITNUM, MOTESTCD, MOLOC, MOLAT |
mo.xpt |
MS |
Microbiology Susceptibility |
Findings |
One record per microbiology susceptibility test (or other organism-related finding) per organism found in MB |
Tabulation |
STUDYID, USUBJID, MSTESTCD, VISITNUM, MSTPTREF, MSTPTNUM |
ms.xpt |
NV |
Nervous System Findings |
Findings |
One record per finding per location per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, VISITNUM, CVTPTNUM, CVLOC, NVTESTCD |
nv.xpt |
OE |
Ophthalmic Examinations |
Findings |
One record per ophthalmic finding per method per location, per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, FOCID, OETESTCD, OETSTDTL, OEMETHOD, OELOC, OELAT, OEDIR, VISITNUM, OEDTC, OETPTREF, OETPTNUM, OEREPNUM |
oe.xpt |
PC |
Pharmacokinetics Concentrations |
Findings |
One record per sample characteristic or time-point concentration per reference time point or per analyte per subject |
Tabulation |
STUDYID, USUBJID, PCTESTCD, VISITNUM, PCTPTREF, PCTPTNUM |
pc.xpt |
PE |
Physical Examination |
Findings |
One record per body system or abnormality per visit per subject |
Tabulation |
STUDYID, USUBJID, PETESTCD, VISITNUM |
pe.xpt |
PP |
Pharmacokinetics Parameters |
Findings |
One record per PK parameter per time-concentration profile per modeling method per subject |
Tabulation |
STUDYID, USUBJID, PPTESTCD, PPCAT, VISITNUM, PPTPTREF |
pp.xpt |
QS |
Questionnaires |
Findings |
One record per questionnaire per question per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, QSCAT, QSSCAT, VISITNUM, QSTESTCD |
qs.xpt |
RE |
Respiratory System Findings |
Findings |
One record per finding or result per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, VISITNUM, RETESTCD, RETPTNUM, REREPNUM |
re.xpt |
RP |
Reproductive System Findings |
Findings |
One record per finding or result per time point per visit per subject |
Tabulation |
STUDYID, DOMAIN, USUBJID, RPTESTCD, VISITNUM |
rp.xpt |
RS |
Disease Response and Clin Classification |
Findings |
One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator |
Tabulation |
STUDYID, USUBJID, RSTESTCD, VISITNUM, RSTPTREF, RSTPTNUM, RSEVAL, RSEVALID |
rs.xpt |
SC |
Subject Characteristics |
Findings |
One record per characteristic per subject. |
Tabulation |
STUDYID, USUBJID, SCTESTCD |
sc.xpt |
SR |
Skin Response |
Findings |
One record per finding, per object, per time point, per visit per subject |
Tabulation |
STUDYID, USUBJID, SRTESTCD, SROBJ, VISITNUM, SRTPTREF, SRTPTNUM |
sr.xpt |
SS |
Subject Status |
Findings |
One record per finding per visit per subject |
Tabulation |
STUDYID, USUBJID, SSTESTCD, VISITNUM |
ss.xpt |
TR |
Tumor/Lesion Results |
Findings |
One record per tumor measurement/assessment per visit per subject per assessor |
Tabulation |
STUDYID, USUBJID, TRTESTCD, EVALID, VISITNUM |
tr.xpt |
TU |
Tumor/Lesion Identification |
Findings |
One record per identified tumor per subject per assessor |
Tabulation |
STUDYID, USUBJID, EVALID, LNKID |
tu.xpt |
UR |
Urinary System Findings |
Findings |
One record per finding per location per per visit per subject |
Tabulation |
STUDYID, USUBJID, VISITNUM, URTESTCD, URLOC, URLAT, URDIR |
ur.xpt |
VS |
Vital Signs |
Findings |
One record per vital sign measurement per time point per visit per subject |
Tabulation |
STUDYID, USUBJID, VSTESTCD, VISITNUM, VSTPTREF, VSTPTNUM |
vs.xpt |
TA |
Trial Arms |
Trial Design |
One record per planned Element per Arm |
Tabulation |
STUDYID, ARMCD, TAETORD |
ta.xpt |
TD |
Trial Disease Assessments |
Trial Design |
One record per planned constant assessment period |
Tabulation |
STUDYID, TDORDER |
td.xpt |
TE |
Trial Elements |
Trial Design |
One record per planned Element |
Tabulation |
STUDYID, ETCD |
te.xpt |
TI |
Trial Inclusion/Exclusion Criteria |
Trial Design |
One record per I/E crierion |
Tabulation |
STUDYID, IETESTCD |
ti.xpt |
TM |
Trial Disease Milestones |
Trial Design |
One record per Disease Milestone type |
Tabulation |
STUDYID, MIDSTYPE |
tm.xpt |
TS |
Trial Summary Information |
Trial Design |
One record per trial summary parameter value |
Tabulation |
STUDYID, TSPARMCD, TSSEQ |
ts.xpt |
TV |
Trial Visits |
Trial Design |
One record per planned Visit per Arm |
Tabulation |
STUDYID, ARM, VISIT |
tv.xpt |
RELREC |
Related Records |
Relationships |
One record per related record, group of records or dataset |
Tabulation |
STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID |
relrec.xpt |
RELSUB |
Related Subjects |
Relationships |
One record per relationship per related subject per subject |
Tabulation |
STUDYID, USUBJID, RSUBJID, SREL |
relsub.xpt |
SUPP– |
Supplemental Qualifiers for [domain name] |
Relationships |
One record per IDVAR, IDVARVAL, and QNAM value per subject |
Tabulation |
STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM |
supp–.xpt |
OI |
Non-host Organism Identifiers |
Study Reference |
One record per taxon per non-host organism |
Tabulation |
NHOID, OISEQ |
oi.xpt |