|
Column Name
|
Column Value
|
|---|---|
|
SASref
|
REFMETA
|
|
Table
|
AE
|
|
Label
|
Adverse Events
|
|
Class
|
Events
|
|
XmlPath
|
.../transport/ae.xpt
|
|
XmlTitle
|
Adverse Events SAS transport
file
|
|
Structure
|
One record per adverse
event per subject
|
|
Purpose
|
Tabulation
|
|
Keys
|
STUDYID USUBJID AEDECOD
AESTDTC
|
|
State
|
Final
|
|
Date
|
2013-11-26
|
|
Standard
|
CDISC-SDTM
|
|
StandardVersion
|
3.2
|
|
Standardref
|
SDTMIG 3.2, section
6.2
|
|
Comment
|
“The Adverse
Events dataset includes clinical data describing "any untoward
medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily
have to have a causal relationship with this treatment" (ICH
E2A). The events included in the AE dataset should be consistent with
the protocol requirements. Adverse events may be captured either as
free text or via a pre-specified list of terms.”
|
|
Column Name
|
Column Value
|
|---|---|
|
sasref
|
REFMETA
|
|
table
|
AE
|
|
column
|
AESEV
|
|
label
|
Severity/Intensity
|
|
order
|
26
|
|
type
|
C
|
|
length
|
20
|
|
displayformat
|
|
|
xmldatatype
|
text
|
|
xmlcodelist
|
AESEV
|
|
core
|
Perm
|
|
origin
|
|
|
role
|
RecordQualifier
|
|
term
|
(AESEV)
|
|
algorithm
|
|
|
qualifiers
|
UPPERCASE
|
|
standard
|
CDISC-SDTM
|
|
standardversion
|
3.2
|
|
standardref
|
|
|
comment
|
The severity or intensity
of the event. Examples: MILD, MODERATE, SEVERE.
|
validation/control folder contains
the superset of checks validating the domain structure and content
for each specific SDTM version.
messages folder
provides error messaging for all Validation Master checks.
macros folder
provides code specific to SDTM that augments code that is provided
in the primary SAS Clinical Standards Toolkit autocall library (!sasroot/cstframework/sasmacro).
|
Adverse Events - AE
|
PK Concentrations -
PC
|
|
Clinical Events - CE
|
Physical Examination
- PE
|
|
Concomitant Medications
- CM
|
PK Parameters - PP
|
|
Comments - CO
|
Questionnaires - QS
|
|
Drug Accountability
- DA
|
Related Records - RELREC
|
|
Demographics - DM
|
Subject Characteristics
- SC
|
|
Disposition - DS
|
Subject Elements - SE
|
|
Protocol Deviations
- DV
|
Substance Use - SU
|
|
ECG Test Results - EG
|
Supplemental Qualifiers
- AE - SUPPAE
|
|
Exposure - EX
|
Subject Visits - SV
|
|
Findings About - FA
|
Trial Arms - TA
|
|
Inclusion/Exclusion
Criterion Not Met - IE
|
Trial Elements - TE
|
|
Laboratory Test Results
- LB
|
Trial Inclusion/Exclusion
Criteria - TI
|
|
Microbiology Specimen
- MB
|
Trial Summary - TS
|
|
Medical History - MH
|
Trial Visits - TV
|
|
Microbiology Susceptibility
Test - MS
|
Vital Signs - VS
|
|
Adverse Events - AE
|
Clinical Events - CE
|
|
Concomitant Medications
- CM
|
Comments - CO
|
|
Drug Accountability
- DA
|
Demographics - DM
|
|
Disposition - DS
|
Protocol Deviations
- DV
|
|
ECG Test Results - EG
|
Exposure - EX
|
|
Findings About - FA
|
Inclusion/Exclusion
Criterion Not Met - IE
|
|
Laboratory Test Results
- LB
|
Microbiology Specimen
- MB
|
|
Medical History - MH
|
Microbiology Susceptibility
- MS
|
|
PK Concentrations -
PC
|
Physical Examination
- PE
|
|
Pool Definition - POOLDEF
|
PK Parameters - PP
|
|
Questionnaire - QS
|
Related Records - RELREC
|
|
Disease Response - RS
|
Subject Characteristics
- SC
|
|
Subject Elements - SE
|
Substance Use - SU
|
|
Supplemental Qualifiers
- AE - SUPPAE
|
Subject Visits - SV
|
|
Trial Arms - TA
|
Trial Elements - TE
|
|
Trial Inclusion/Exclusion
Criteria - TI
|
Tumor Results - TR
|
|
Trial Summary - TS
|
Tumor Identification
- TU
|
|
Trial Visits - TV
|
Vital Signs - VS
|
|
Adverse Events - AE
|
Morphology - MO
|
|
Associated Persons Demographics
- APDM
|
Microbiology Susceptibility
- MS
|
|
Associated Persons Related
to Subjects - APRELSUB
|
PK Concentrations -
PC
|
|
Clinical Events - CE
|
Physical Examination
- PE
|
|
Concomitant Medications
- CM
|
Pool Definition - POOLDEF
|
|
Comments - CO
|
PK Parameters - PP
|
|
Drug Accountability
- DA
|
Procedures - PR
|
|
Death Details - DD
|
Questionnaire - QS
|
|
Device Events - DE
|
Related Records - RELREC
|
|
Study Device Identifiers
- DI
|
Related Subjects - RELSUB
|
|
Demographics - DM
|
Reproductive System
Findings - RP
|
|
Device Properties -
DO
|
Disease Response - RS
|
|
Device-Subject Relationships
- DR
|
Subject Characteristics
- SC
|
|
Disposition - DS
|
Subject Elements - SE
|
|
Device Tracking and
Disposition - DT
|
Skin Response - SR
|
|
Device In-Use - DU
|
Subject Status - SS
|
|
Protocol Deviations
- DV
|
Substance Use - SU
|
|
Device Exposure - DX
|
Supplemental Qualifiers
- SUPP
|
|
Exposure as Collected
- EC
|
Subject Visits - SV
|
|
ECG Test Results - EG
|
Trial Arms - TA
|
|
Exposure - EX
|
Trial Disease Assessments
- TD
|
|
Findings About - FA
|
Trial Elements - TE
|
|
Healthcare Encounters
- HO
|
Trial Inclusion/Exclusion
Criteria - TI
|
|
Inclusion/Exclusion
Criterion Not Met - IE
|
Tumor Results - TR
|
|
Immunogenicity Specimen
Assessment - IS
|
Trial Summary - TS
|
|
Laboratory Test Results
- LB
|
Tumor Identification
- TU
|
|
Microbiology Specimen
- MB
|
Trial Visits - TV
|
|
Medical History - MH
|
Vital Signs - VS
|
|
Microscopic Findings
- MI
|