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Variables that describe the record are often used in analysis. Include these and any other SDTM variables if used in analysis. If the analysis version of the variable differs from the version in the SDTM, additional variables must be added using the conventions below and described in Section 2.9.3, How to Create Analysis Variables.
The following table below lists some common descriptive variables that are often included in ADAE. Any other SDTM variables should be included as appropriate (e.g. AEOUT, AESDTH).
Adverse Event Descriptive Variables
...
Variable Name
...
Variable Label
...
Type
...
Codelist
...
Controlled Terms
...
Core
...
SubClass ADVERSE EVENT Core
...
CDISC Notes
...
--SER
...
Serious Event
...
Char
...
(NY)
...
Perm
...
Req
...
XX.--SER
...
--SEV
...
Severity/Intensity
...
Char
...
(AESEV) or (SEVRS)
...
Perm
...
Cond
...
XX.--SEV
For SubClass ADVERSE EVENT, conditional on whether the --SEV variable is in the SDTM AE dataset. Note that either --SEV or --TOXGR should be included in
SDTM.
...
--SEVN
...
Severity/Intensity (N)
...
Num
...
1, 2, 3
...
Perm
...
Perm
...
Code XX.--SEV to numeric
Low intensity should correspond to low value
...
ASEV
...
Analysis Severity/Intensity
...
Char
...
*
...
Perm
...
Perm
...
Apply imputation rules for missing severity of adverse events as specified in the
SAP or metadata. May change case of text, such as from all uppercase in --SEV to mixed case in ASEV.
...
ASEVN
...
Analysis Severity/Intensity (N)
...
Num
...
1, 2, 3
...
Perm
...
Perm
...
Code ASEV to numeric
Low intensity should correspond to low value
| Include Page | ||||
|---|---|---|---|---|
|
...
SEVGRy
...
Pooled Severity Group y
...
Char
...
*
...
Perm
...
Perm
...
Pooled grouping of AE severity for analysis (e.g., mild/moderate, severe)
...
SEVGRyN
...
Pooled Severity Group y (N)
...
Num
...
*
...
Perm
...
Perm
...
Code SEVGRy to numeric
Low intensity should correspond to low value
...
--REL
...
Causality
...
Char
...
*
...
Perm
...
Req
...
XX.--REL
...
--RELN
...
Causality (N)
...
Num
...
*
...
Perm
...
Perm
...
Code XX.--REL to numeric
Low relation should correspond to low value
...
AREL
...
Analysis Causality
...
Char
...
*
...
Perm
...
Perm
...
Apply imputation rules for missing causality of study drug as specified in the SAP or metadata. May change case of text, such as from all uppercase in --REL to mixed case in AREL.
...
ARELN
...
Analysis Causality (N)
...
Num
...
*
...
Perm
...
Perm
...
Code AREL to numeric
...
RELGRy
...
Pooled Causality Group y
...
Char
...
*
...
Perm
...
Perm
...
Pooled grouping of causality of study drug for analysis (e.g. related, not related)
...
RELGRyN
...
Pooled Causality Group y (N)
...
Num
...
*
...
Perm
...
Perm
...
Code of RELGRy to numeric
Low relation should correspond to low value
...
--TOXGR
...
Standard Toxicity Grade
...
Char
...
*
...
Perm
...
Cond
...
XX.--TOXGR
For SubClass ADVERSE EVENT, conditional on whether the --TOXGR variable is in the SDTM AE dataset. Note that either --SEV or --TOXGR should be included in SDTM.
...
--TOXGRN
...
Standard Toxicity Grade (N)
...
Num
...
*
...
Perm
...
Perm
...
Code --TOXGR to numeric
Low toxicity should correspond to low value
...
ATOXGR
...
Analysis Toxicity Grade
...
Char
...
*
...
Perm
...
Perm
...
Toxicity grade for analysis. May be based on --TOXGR or an imputed or assigned value. May change case of text, such as from all uppercase in --TOXGR to mixed
case in ATOXGR.
...
ATOXGRN
...
Analysis Toxicity Grade (N)
...
Num
...
*
...
Perm
...
Perm
...
Code ATOXGR to numeric
Low toxicity should correspond to low value
...
TOXGGRy
...
Pooled Toxicity Grade Group y
...
Char
...
*
...
Perm
...
Perm
...
Pooled grouping of toxicity grade for analysis
...
TOXGGRyN
...
Pooled Toxicity Grade Group y (N)
...
Num
...
*
...
Perm
...
Perm
...
Code of TOXGGRy to numeric
Low toxicity should correspond to low value
...
--ACN
...
Action Taken with Study Product
...
Char
...
(ACN)
...
Perm
...
Cond
...
XX.--ACN
Required if XX.--ACN is present and populated
Medical history data typically does not contain descriptive variables. If needed for analysis, use variables as shown in Table 3.2.8.1 above for adverse events, replacing the prefix “AE” with “MH”.
Concomitant Medications Descriptive Variables
...
Variable Name
...
Variable Label
...
Type
...
Codelist
...
Controlled Terms
...
Core
...
CDISC Notes
...
--STAT
...
Completion Status
...
Char
...
Perm
...
XX.--STAT
| Include Page | ||||
|---|---|---|---|---|
|
...
--INDC
...
Indication
...
Char
...
Perm
...
XX.--INDC
...
--DOSE
...
Dose per Administration
...
Num
...
Perm
...
XX.--DOSE
...
--DOSFRM
...
Dose Form
...
Char
...
Perm
...
XX.--DOSFRM
...
--DOSRGM
...
Intended Dose Regimen
...
Char
...
Perm
...
XX.--DOSRGM
...
--ROUTE
...
Route of Administration
...
Char
...
Perm
...
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