Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
TRTSDT | Date of First Exposure to Product | Num | Cond | Date of first exposure to product for a subject in a study. TRTSDT and/or TRTSDTM are required if there is an investigational product. Note that TRTSDT is not required to have the same value as the SDTM DM variable RFXSTDTC. While both of these dates reflect the concept of first exposure, the ADaM date may be derived to support the analysis which may not necessarily be the very first date in the SDTM EX domain. | |
TRTSTM | Time of First Exposure to Product | Num | Perm | Time of first exposure to product for a subject in a study. | |
TRTSDTM | Datetime of First Exposure to Product | Num | Cond | Datetime of first exposure to product for a subject in a study. TRTSDT and/or TRTSDTM are required if there is an investigational product. | |
TRTSDTF | Date of First Exposure Imput. Flag | Char | (DATEFL) | Cond | The level of imputation of date of first exposure to product. If TRTSDT (or the date part of TRTSDTM) was imputed, TRTSDTF must be populated and is required. See Date and Time Imputation Flag Variables |
TRTSTMF | Time of First Exposure Imput. Flag | Char | (TIMEFL) | Cond | The level of imputation of time of first exposure to product. If TRTSTM (or the time part of TRTSDTM) was imputed, TRTSTMF must be populated and is required. See Date and Time Imputation Flag Variables |
TRTEDT | Date of Last Exposure to Product | Num | Cond | Date of last exposure to product for a subject in a study. TRTEDT and/or TRTEDTM are required if there is an investigational product. Note that TRTEDT is not required to have the same value as the SDTM DM variable RFXENDTC. While both of these dates reflect the concept of last exposure, the ADaM date may be derived to support the analysis which may not necessarily be the very last date in the SDTM EX domain. | |
TRTETM | Time of Last Exposure to Product | Num | Perm | Time of last exposure to product for a subject in a study. | |
TRTEDTM | Datetime of Last Exposure to Product | Num | Cond | Datetime of last exposure to product for a subject in a study. TRTEDT and/or TRTEDTM are required if there is an investigational product. | |
TRTEDTF | Date of Last Exposure Imput. Flag | Char | (DATEFL) | Cond | The level of imputation of date of last exposure to product. If TRTEDT (or the date part of TRTEDTM) was imputed, TRTEDTF must be populated and is required. See Date and Time Imputation Flag Variables |
TRTETMF | Time of Last Exposure Imput. Flag | Char | (TIMEFL) | Cond | The level of imputation of time of last exposure to product. If TRTETM (or the time part of TRTEDTM) was imputed, TRTETMF must be populated and is required. See Date and Time Imputation Flag Variables |
TRxxSDT | Date of First Exposure in Period xx | Num | Cond | Date of first exposure to product in period xx. TRxxSDT and/or TRxxSDTM are only required in trial designs where multiple product periods are defined (i.e., required when there is a TRTxxP other than TRT01P). Examples include crossover designs or designs where multiple periods exist for the same product. | |
TRxxSTM | Time of First Exposure in Period xx | Num | Cond | Starting time of exposure to product in period xx. TRxxSTM and/or TRxxSDTM are only required in trial designs where starting time is important to the analysis and multiple product periods are defined (i.e., required when there is a TRTxxP other than TRT01P). | |
TRxxSDTM | Datetime of First Exposure in Period xx | Num | Cond | Datetime of first exposure to product in period xx. TRxxSDTM is only required in trial designs where multiple product periods are defined (i.e., required when there is a TRTxxP other than TRT01P). | |
TRxxSDTF | Date 1st Exposure Period xx Imput. Flag | Char | (DATEFL) | Cond | The level of imputation of date of first exposure to product in period xx. If TRxxSDT (or the date part of TRxxSDTM) was imputed, TRxxSDTF must be populated and is required. See Date and Time Imputation Flag Variables |
TRxxSTMF | Time 1st Exposure Period xx Imput. Flag | Char | (TIMEFL) | Cond | The level of imputation of time of first exposure to product in period xx. If TRxxSTM (or the time part of TRxxSDTM) was imputed, TRxxSTMF must be populated and is required. See Date and Time Imputation Flag Variables |
TRxxEDT | Date of Last Exposure in Period xx | Num | Cond | Date of last exposure to product in period xx. TRxxEDT and/or TRxxEDTM are only required in trial designs where multiple product periods are defined (i.e., required when there is a TRTxxP other than TRT01P). | |
TRxxETM | Time of Last Exposure in Period xx | Num | Cond | Ending time of exposure to product in period xx. TRxxETM and/or TRxxEDTM are only required in trial designs where ending time is important to the analysis and multiple product periods are defined (i.e., required when there is a TRTxxP other than TRT01P). | |
TRxxEDTM | Datetime of Last Exposure in Period xx | Num | Cond | Datetime of last exposure to product in period xx. TRxxEDTM is only required in trial designs where multiple product periods are defined (i.e., required when there is a TRTxxP other than TRT01P). | |
TRxxEDTF | Date Last Exposure Period xx Imput. Flag | Char | (DATEFL) | Cond | The level of imputation of date of last exposure to product in period xx. If TRxxEDT (or the date part of TRxxEDTM) was imputed, TRxxEDTF must be populated and is required. See Date and Time Imputation Flag Variables |
TRxxETMF | Time Last Exposure Period xx Imput. Flag | Char | (TIMEFL) | Cond | The level of imputation of time of last exposure to product in period xx. If TRxxETM (or the time part of TRxxEDTM) was imputed, TRxxETMF must be populated and is required. See Date and Time Imputation Flag Variables |
Additional timing variables can be included for phase, period, and subperiod (APHASE, APERIOD, and ASPER, defined in Timing Variables for BDS Datasets. ADSL Subject-Level Period, Subperiod, and Phase Timing Variables provides the subject-level variables for these timing elements.
The following provisions apply to the inclusion or exclusion of sets of pairs of subject-level analysis timing variables in ADSL. A set of pairs of subject-level analysis timing variable is the set of start and end variables for an analysis timing element, such as phase, period, or subperiod. For example, for analysis period, the set consists of APxxSDT and APxxEDT for all of the analysis periods xx in the study. The set of timing variables for a specific phase, period, or subperiod includes only those variables from ADSL Subject-Level Period, Subperiod, and Phase Timing Variables that are applicable to the study. For example, although the period start time is defined, it should be included in the set of analysis period timing variables only if needed for the study.
- A set of analysis timing variables can be included in ADSL only if the definitions for all of the variables in the set are fixed across the study (i.e., the definitions of the start and end of each timing element for a given subject do not change based on endpoint or data type). The first such set consists of all of the analysis period timing variables defined in ADSL Subject-Level Period, Subperiod, and Phase Timing Variables. The second set consists of all of the subperiod timing variables in that table. The third set consists of all of the phase timing variables in that table.
- If period timing variables are not included in ADSL, then subperiod timing variables must be excluded from
- If any of the definitions of the variables in the set do vary, for example, when analysis period start or stop date definitions differ for safety and efficacy analyses, then none of the variables in the set can be included in ADSL.
- If all of the variable definitions in the set are the same across all datasets, then they can be included in Timing Variables for BDS Datasets specifies variables to be used in the other datasets when definitions differ by dataset.
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