| 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
|
