| Dataset
|
Description
|
Location
|
Structure
|
Purpose
|
| DM
|
Demographics
|
DM.XPT
|
One record per subject
|
Tabulation
|
| CO
|
Comments
|
CO.XPT
|
One record per comment per subject
|
Tabulation
|
| CM
|
Concomitant
|
CM.XPT
|
One record per medication intervention episode per subject
|
Tabulation
|
| EX
|
Exposure
|
EX.XPT
|
One record per constant dosing interval per subject
|
Tabulation
|
| SU
|
Substance Use
|
SU.XPT
|
One record per substance use type per subject
|
Tabulation
|
| AE
|
Adverse Events
|
SAEXPT
|
One record per event per subject
|
Tabulation
|
| DS
|
Disposition
|
DS.XPT
|
One record per disposition status or protocol milestone per subject
|
Tabulation
|
| MH
|
Medical History
|
MH.XPT
|
One record per medical history event per subject
|
Tabulation
|
| EG
|
ECG
|
EG.XPT
|
One record per ECG measurement per subject
|
Tabulation
|
| IE
|
Inclusion/Exclusion Exceptions
|
IE.XPT
|
One record per I/E criteria not met per subject
|
Tabulation
|
| LB
|
Laboratory Tests
|
LB.XPT
|
One record per lab test per subject
|
Tabulation
|
| PE
|
Physical Exam
|
PE.XPT
|
One record per subject or body system or body system finding
|
Tabulation
|
| QS
|
Questionnaires
|
QS.XP
|
one record per question per subject
|
Tabulation
|
| SC
|
Subject Characteristics
|
SC.XPT
|
One record per subject characteristic
|
Tabulation
|
| VS
|
Vital Signs
|
VS.XPT
|
One record per vital sign measurement per subject
|
Tabulation
|
| TE
|
Trial Elements
|
TE.XPT
|
One record per element
|
Tabulation
|
| TA
|
Trial Arms
|
TA.XPT
|
One record per element per arm
|
Tabulation
|
| TV
|
Trial Visits
|
TV.XPT
|
One record per visit per arm
|
Tabulation
|
| SE
|
Subject Elements
|
SE.XPT
|
One record per actual element per subject
|
Tabulation
|
| SV
|
Subject Visits
|
SV.XPT
|
One record per subject per actual visit
|
Tabulation
|
| TI
|
Trial Inclusion/ Exclusion Criteria
|
TI.XPT
|
One record per I/E criterion
|
Tabulation
|
| RELREC
|
Related Records
|
RELREC .XPT
|
One record per relationship
|
Tabulation
|
| SUPPQAL
|
Supplemental Qualifiers
|
SUPPQUAL.XPT
|
One record per qualifier value.
|
Tabulation
|
