You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 3 Next »

Timing variables are copied from the SDTM and derived within ADaM. Common timing variables are provided in this section. If other timing variables are collected in SDTM and pertinent for analysis, these should be included in ADaM. Additional timing variables, such as those for period start and end dates, can be included. For more details on timing variables, see ADD LINK ADaMIG Section 3.3.3, Timing Variables for BDS Datasets.


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 ADD LINK ADaMIG v1.2 Section 3.1.3, 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 ADD LINK ADaMIG v1.2 Section 3.1.3, 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 ADD LINK ADaMIG v1.2 Section 3.1.3, 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 ADD LINK ADaMIG v1.2 Section 3.1.3, 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 ADD LINK ADaMIG v1.2 Section 3.3.3, Timing Variables for BDS variables 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 TREATMENT, and FOLLOW-UP.

  • No labels