| Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
|---|
--STDTC | Start Date/Time of Observation | Char | ISO 8601 datetime or interval | | 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. AESTDTC is required for adverse event data. |
ASTDT | Analysis Start Date | Num |
| Cond | 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. Required for adverse event data. |
ASTTM | Analysis Start Time | Num |
| 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 | 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 | The level of imputation of analysis start date. Imputation flags are described in 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 | The level of imputation of analysis start time. Imputation flags are described in 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 datetime or interval | Cond | 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. AEENDTC is required for adverse event data. |
AENDT | Analysis End Date | Num |
| Cond | Created from converting XX.--ENDTC from character ISO 8601 format to numeric date format, applying imputation rules if specified in the SAP or metadata. If both ASTDT and AENDT are populated then ASTDT must less than or equal to AENDT. Conditional on whether end date is pertinent for study and is populated in SDTM. Required for adverse event data. |
AENTM | Analysis End Time | Num |
| 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 | Created from converting XX.--ENDTC from character ISO 8601 format to numeric datetime format, applying imputation rules if specified in the SAP or metadata. If both ASTDTM and AENDTM are populated then ASTDTM must less than or equal to AENDTM. Conditional on whether end datetime is pertinent for study and is populated in SDTM |
AENDTF | Analysis End Date Imputation Flag | Char | (DATEFL) | Cond | The level of imputation of analysis end date. Imputation flags are described in Section 2.9.3.3, 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 | The level of imputation of analysis end time. Imputation flags are described in Section 2.9.3.3, 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 | 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. Required for adverse event data. |
--STDY | Study Day of Start of Observation* | Num |
| Perm | 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 | 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. If both ASTDY and AENDY are populated then ASTDY must be less than or equal to AENDY. Required for adverse event data. |
--ENDY | Study Day of End of Observation* | Num |
| Perm | 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. If both --STDY and --ENDY are populated then --STDY must be less than or equal to --ENDY For SubClass ADVERSE EVENT, conditional on whether the AEENDY variable is in the SDTM AE dataset |
ADURN | Analysis Duration (N) | Num |
| Perm | Derive from ASTDT (or ASTDTM) and AENDT (or AENDTM). |
ADURU | Analysis Duration Units | Char | (UNIT) | Cond | Conditional on whether ADURN is included |
--DUR | Duration of XX | Char | | 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 | 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 Section 2.9.6.3, Timing Variables for BDS Datasets, for more information on this variable. |
APERIODC | Period (C) | Char |
| Perm | Text characterizing to which period the record belongs. One-to-one map to APERIOD. |
| Phase | Char |
| 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. |