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Additional timing variables can be included for phase, period, and subperiod (APHASE, APERIOD, and ASPER, defined in Section 2.9.6.3, Timing Variables for BDS Datasets). Section 2.9.5.7, Subject-Level Period, Subperiod, and Phase Timing Variables for ADSL Datasets, 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 Section 2.9.5.7, Subject-Level Period, Subperiod, and Phase Timing Variables for ADSL Datasets, 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 Section 2.9.5.7, Subject-Level Period, Subperiod, and Phase Timing Variables for ADSL Datasets. 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 ADSL.
- 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 different types of 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 Section 2.9.6.3, Timing Variables for BDS Datasets, specifies variables to be used in the other datasets when definitions differ by dataset.
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Variable Name
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Variable Label
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Type
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Codelist/ Controlled Terms
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Core
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CDISC Notes
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TRTSDT
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Date of First Exposure to Treatment
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Num
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Cond
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Date of first exposure to treatment 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.
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TRTSTM
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Time of First Exposure to Treatment
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Num
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Perm
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Time of first exposure to treatment for a subject in a study.
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TRTSDTM
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Datetime of First Exposure to Treatment
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Num
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Cond
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Datetime of first exposure to treatment for a subject in a study. TRTSDT and/or TRTSDTM are required if there is an investigational product.
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TRTSDTF
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Date of First Exposure Imput. Flag
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Char
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(DATEFL)
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Cond
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The level of imputation of date of first exposure to treatment. If TRTSDT (or the date part of TRTSDTM) was imputed, TRTSDTF must be populated and is required. See ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.
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TRTSTMF
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Time of First Exposure Imput. Flag
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Char
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(TIMEFL)
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Cond
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The level of imputation of time of first exposure to treatment. If TRTSTM (or the time part of TRTSDTM) was imputed, TRTSTMF must be populated and is required. See ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.
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TRTEDT
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Date of Last Exposure to Treatment
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Num
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Cond
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Date of last exposure to treatment 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.
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TRTETM
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Time of Last Exposure to Treatment
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Num
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Perm
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Time of last exposure to treatment for a subject in a study.
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TRTEDTM
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Datetime of Last Exposure to Treatment
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Num
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Cond
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Datetime of last exposure to treatment for a subject in a study. TRTEDT and/or TRTEDTM are required if there is an investigational product.
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TRTEDTF
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Date of Last Exposure Imput. Flag
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Char
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(DATEFL)
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Cond
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The level of imputation of date of last exposure to treatment. If TRTEDT (or the date part of TRTEDTM) was imputed, TRTEDTF must be populated and is required. See ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.
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TRTETMF
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Time of Last Exposure Imput. Flag
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Char
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(TIMEFL)
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Cond
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The level of imputation of time of last exposure to treatment. If TRTETM (or the time part of TRTEDTM)
was imputed, TRTETMF must be populated and is required. See ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.
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TRxxSDT
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Date of First Exposure in Period xx
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Num
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Cond
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Date of first exposure to treatment in period xx. TRxxSDT and/or TRxxSDTM are only required in trial designs where multiple treatment 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
treatment.
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TRxxSTM
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Time of First Exposure in Period xx
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Num
...
Cond
Starting time of exposure to treatment in period xx. TRxxSTM and/or TRxxSDTM are only required in trial
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