Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
APxxSDT | Period xx Start Date | Num | Perm | The starting date of period xx. | |
APxxSTM | Period xx Start Time | Num | Perm | The starting time of period xx. | |
APxxSDTM | Period xx Start Datetime | Num | Perm | The starting datetime of period xx. | |
APxxSDTF | Period xx Start Date Imput. Flag | Char | (DATEFL) | Cond | The level of imputation of period xx start date. See Date and Time Imputation Flag Variables. |
APxxSTMF | Period xx Start Time Imput. Flag | Char | (TIMEFL) | Cond | The level of imputation of period xx start time. See Date and Time Imputation Flag Variables. |
APxxEDT | Period xx End Date | Num | Perm | The ending date of period xx. | |
APxxETM | Period xx End Time | Num | Perm | The ending time of period xx. | |
APxxEDTM | Period xx End Datetime | Num | Perm | The ending datetime of period xx. | |
APxxEDTF | Period xx End Date Imput. Flag | Char | (DATEFL) | Cond | The level of imputation of period xx end date. See Date and Time Imputation Flag Variables. |
APxxETMF | Period xx End Time Imput. Flag | Char | (TIMEFL) | Cond | The level of imputation of period xx end time. See Date and Time Imputation Flag Variables. |
PxxSw | Description of Period xx Subperiod w | Char | Perm | Description of analysis subperiod w within period xx. | |
PxxSwSDT | Period xx Subperiod w Start Date | Num | Perm | The starting date of subperiod w within period xx. | |
PxxSwSTM | Period xx Subperiod w Start Time | Num | Perm | The starting time of subperiod w within period xx. | |
PxxSwSDM | Period xx Subperiod w Start Datetime | Num | Perm | The starting datetime of subperiod w within period xx. | |
PxxSwSDF | Period xx Subper w Start Date Imput Flag | Char | (DATEFL) | Cond | The level of imputation of the start date for subperiod w within period xx. See Date and Time Imputation Flag Variables. |
PxxSwSTF | Period xx Subper w Start Time Imput Flag | Char | (TIMEFL) | Cond | The level of imputation of the start time for subperiod w within period xx. See Date and Time Imputation Flag Variables. |
PxxSwEDT | Period xx Subperiod w End Date | Num | Perm | The ending date of subperiod w within period xx. | |
PxxSwETM | Period xx Subperiod w End Time | Num | Perm | The ending time of subperiod w within period xx. | |
PxxSwEDM | Period xx Subperiod w End Datetime | Num | Perm | The ending datetime of subperiod w within period xx. | |
PxxSwEDF | Period xx Subper w End Date Imput Flag | Char | (DATEFL) | Cond | The level of imputation of the end date for subperiod w within period xx. See Date and Time Imputation Flag Variables. |
PxxSwETF | Period xx Subper w End Time Imput Flag | Char | (TIMEFL) | Cond | The level of imputation of the end time for subperiod w within period xx. See Date and Time Imputation Flag Variables. |
APHASEw | Description of Phase w | Char | Perm | Description of analysis phase w. Analysis phase is independent of TRTxxP within ADSL, and may be populated for spans of time where a subject is not on treatment. | |
PHwSDT | Phase w Start Date | Num | Perm | The starting date of phase w. | |
PHwSTM | Phase w Start Time | Num | Perm | The starting time of phase w. | |
PHwSDTM | Phase w Start Datetime | Num | Perm | The starting datetime of phase w. | |
PHwSDTF | Phase w Start Date Imputation Flag | Char | (DATEFL) | Cond | The level of imputation of the start date for phase w. See Date and Time Imputation Flag Variables. |
PHwSTMF | Phase w Start Time Imputation Flag | Char | (TIMEFL) | Cond | The level of imputation of the start time for phase w. See Date and Time Imputation Flag Variables. |
PHwEDT | Phase w End Date | Num | Perm | The ending date of phase w. | |
PHwETM | Phase w End Time | Num | Perm | The ending time of phase w. | |
PHwEDTM | Phase w End Datetime | Num | Perm | The ending datetime of phase w. | |
PHwEDTF | Phase w End Date Imputation Flag | Char | (DATEFL) | Cond | The level of imputation of the end date for phase w. See Date and Time Imputation Flag Variables. |
PHwETMF | Phase w End Time Imputation Flag | Char | (TIMEFL) | Cond | The level of imputation of the end time for phase w. See Date and Time Imputation Flag Variables. |
Additional timing variables can be included for phase, period, and subperiod (APHASE, APERIOD, and ASPER, defined in Subject-Level Period, Subperiod, and Phase Timing Variables for ADSL Datasets. 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 Table 3.2.7 that are applicable to the study. For example, although the period start time is defined in Table 3.2.7, 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 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
- 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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