Page History
...
Variable Name
...
Variable Label
...
Type
...
Codelista
...
Controlled Terms
...
Core
...
SubClass ADVERSE EVENT Core
...
CDISC Notes
...
--STDTC
...
Start Date/Time of Observation
...
Char
...
ISO 8601
...
Cond
...
Req
...
Copied from XX.–STDTC
Conditional on whether start date is pertinent for study and is populated in SDTM
This variable label differs depending on the SDTM domain.
...
ASTDT
...
Analysis Start Date
...
Num
...
Cond
...
Req
...
Created from converting XX.--STDTC from character ISO 8601 format to numeric date format, applying imputation rules if specified in the statistical analysis plan (SAP) or metadata Conditional on whether start date is pertinent for study and is populated in SDTM
...
ASTTM
...
Analysis Start Time
...
Num
...
Cond
...
Cond
...
Created from converting XX.--STDTC from character ISO 8601 format to numeric time format, applying imputation rules if specified in the SAP or metadata
Conditional on whether start time is pertinent for study and is populated in SDTM
...
ASTDTM
...
Analysis Start Datetime
...
Num
...
Cond
...
Cond
...
Created from converting XX.--STDTC from character ISO 8601 format to numeric datetime format, applying imputation rules if specified in the SAP or metadata
Conditional on whether start datetime is pertinent for study and is populated in SDTM
...
ASTDTF
...
Analysis Start Date Imputation Flag
...
Char
...
(DATEFL)
...
Cond
...
Cond
...
The level of imputation of analysis start date. Imputation flags are described in Date and Time Imputation Flag Variables
Conditional on whether ASTDT (or the date part of ASTDTM) was imputed
...
ASTTMF
...
Analysis Start
Time Imputation Flag
...
Char
...
(TIMEFL)
...
Cond
...
Cond
...
The level of imputation of analysis start time. Imputation flags are described in Date and Time Imputation Flag Variables
Conditional on whether ASTTM (or the time part of ASTDTM) was imputed
...
--ENDTC
...
End Date/Time of Observation
...
Char
...
ISO 8601
...
Cond
...
Req
...
Copied from XX.--ENDTC
Conditional on whether end date is pertinent for study and is populated in SDTM
This variable label differs depending on the SDTM domain.
...
AENDT
...
Analysis End Date
...
Num
...
Cond
...
Req
...
Created from converting XX.--ENDTC from character ISO 8601 format to numeric date format, applying imputation rules if specified in the SAP or metadata
Conditional on whether end date is pertinent for study and is populated in SDTM
...
AENTM
...
Analysis End Time
...
Num
...
Cond
...
Cond
...
Created from converting XX.--ENDTC from character ISO 8601 format to numeric time format, applying imputation rules if specified in the SAP or metadata
Conditional on whether end time is pertinent for study and is populated in SDTM
...
AENDTM
...
Analysis End Datetime
...
Num
...
Cond
...
Cond
...
Created from converting XX.--ENDTC from character ISO 8601 format to numeric datetime format, applying imputation rules if specified in the SAP or metadata
Conditional on whether end datetime is pertinent for study and is populated in SDTM
...
AENDTF
...
Analysis End Date Imputation Flag
...
Char
...
(DATEFL)
...
Cond
...
Cond
...
The level of imputation of analysis end date. Imputation flags are described in Date and Time Imputation Flag Variables
Conditional on whether AENDT (or the date part of AENDTM) was imputed
...
AENTMF
...
Analysis End Time Imputation
Flag
...
Char
...
(TIMEFL)
...
Cond
...
Cond
...
The level of imputation of analysis end time. Imputation flags are described in Date and Time Imputation Flag Variables
Conditional on whether AENTM (or the date part of AENDTM) was imputed
...
ASTDY
...
Analysis Start Relative Day
...
Num
...
Cond
...
Req
...
The number of days from an anchor date (not necessarily DM.RFSTDTC) to ASTDT Example derivation:
ASTDT - ADSL.TRTSDT + 1 if ASTDT >= ADSL.TRTSDT, else ASTDT - ADSL.TRTSDT if ASTDT< ADSL.TRTSDT
This variable may instead be copied from --STDY.
Conditional on whether analysis start relative day is pertinent to the study
...
--STDY
...
Study Day of Start of Observation*
...
Num
...
Perm
...
Cond
...
Copied from XX.--STDY
ASTDY may differ from --STDY due to date imputation and the option in ADaM to use a reference date other than SDTM’s RFSTDTC. Including XX.--STDY in addition to ASTDY adds traceability.
For SubClass ADVERSE EVENT, conditional on whether the AESTDY variable is in the SDTM AE dataset
...
AENDY
...
Analysis End Relative Day
...
Num
...
Perm
...
Req
...
The number of days from an anchor date (not necessarily DM.RFSTDTC) to AENDT Example derivation:
AENDT - ADSL.TRTSDT + 1 if AENDT >= ADSL.TRTSDT, else AENDT - ADSL.TRTSDT if AENDT < ADSL.TRTSDT
This variable may instead be copied from --ENDY.
...
--ENDY
...
Study Day of End of Observation*
...
Num
...
Perm
...
Cond
...
Copied from XX.--ENDY
AENDY may differ from --ENDY due to date imputation and the option in ADaM to use a reference date other than SDTM’s RFSTDTC. Including XX.--ENDY in addition to AENDY adds traceability.
For SubClass ADVERSE EVENT, conditional on whether the AEENDY variable is in the SDTM AE dataset
...
ADURN
...
Analysis Duration (N)
...
Num
...
Perm
...
Perm
...
Derive from ASTDT (or ASTDTM) and AENDT (or AENDTM).
...
ADURU
...
Analysis Duration Units
...
Char
...
(UNIT)
...
Cond
...
Cond
...
Conditional on whether ADURN is included
...
--DUR
...
Duration of XX
...
Char
...
ISO 8601
...
Perm
...
Cond
...
Copied from XX.--DUR
Because --DUR is a collected field and ADURN is derived, the values will often differ. Including XX.--DUR in addition to ADURN adds traceability.
For SubClass ADVERSE EVENT, conditional on whether the AEDUR variable is in the SDTM AE dataset
...
APERIOD
...
Period
...
Num
...
Perm
...
Cond
...
APERIOD is a record-level timing variable that represents the analysis period within the study associated with the record for analysis purposes. The value of APERIOD (if populated) must be one of the xx values found in the ADSL TRTxxP variables. See Timing Variables for BDS Datasets for more information on this variable.
For SubClass ADVERSE EVENT, conditional on whether multiple analysis periods are defined for the study
...
APERIODC
...
Period (C)
...
Char
...
Perm
...
Perm
...
Text characterizing to which period the record belongs. One-to-one map to APERIOD.
...
APHASE
...
Phase
...
Char
...
Perm
...
Perm
...
APHASE is a categorization of timing within a study, for example a higher-level categorization of APERIOD or an analysis epoch. For example, APHASE could describe spans of time for SCREENING, ON PRODUCT, and FOLLOW-UP.
...
Overview
Content Tools