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Variable NameVariable LabelTypeCodelist/ Controlled TermsCoreCDISC Notes
APxxSDTPeriod xx Start DateNum
PermThe starting date of period xx.
APxxSTMPeriod xx Start TimeNum
PermThe starting time of period xx.
APxxSDTMPeriod xx Start DatetimeNum
PermThe starting datetime of period xx.
APxxSDTFPeriod xx Start Date Imput. FlagChar(DATEFL)CondThe level of imputation of period xx start date. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
APxxSTMFPeriod xx Start Time Imput. FlagChar(TIMEFL)CondThe level of imputation of period xx start time. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
APxxEDTPeriod xx End DateNum
PermThe ending date of period xx.
APxxETMPeriod xx End TimeNum
PermThe ending time of period xx.
APxxEDTMPeriod xx End DatetimeNum
PermThe ending datetime of period xx.
APxxEDTFPeriod xx End Date Imput. FlagChar(DATEFL)CondThe level of imputation of period xx end date. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
APxxETMFPeriod xx End Time Imput. FlagChar(TIMEFL)CondThe level of imputation of period xx end time. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
PxxSwDescription of Period xx Subperiod wChar
PermDescription of analysis subperiod w within period xx.
PxxSwSDTPeriod xx Subperiod w Start DateNum
PermThe starting date of subperiod w within period xx.
PxxSwSTMPeriod xx Subperiod w Start TimeNum
PermThe starting time of subperiod w within period xx.
PxxSwSDMPeriod xx Subperiod w Start DatetimeNum
PermThe starting datetime of subperiod w within period xx.
PxxSwSDFPeriod xx Subper w Start Date Imput FlagChar(DATEFL)CondThe level of imputation of the start date for subperiod w within period xx. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
PxxSwSTFPeriod xx Subper w Start Time Imput FlagChar(TIMEFL)CondThe level of imputation of the start time for subperiod w within period xx. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
PxxSwEDTPeriod xx Subperiod w End DateNum
PermThe ending date of subperiod w within period xx.
PxxSwETMPeriod xx Subperiod w End TimeNum
PermThe ending time of subperiod w within period xx.
PxxSwEDMPeriod xx Subperiod w End DatetimeNum
PermThe ending datetime of subperiod w within period xx.
PxxSwEDFPeriod xx Subper w End Date Imput FlagChar(DATEFL)CondThe level of imputation of the end date for subperiod w within period xx. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
PxxSwETFPeriod xx Subper w End Time Imput FlagChar(TIMEFL)CondThe level of imputation of the end time for subperiod w within period xx. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
APHASEwDescription of Phase wChar
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 product.

PHwSDTPhase w Start DateNum
PermThe starting date of phase w.
PHwSTMPhase w Start TimeNum
PermThe starting time of phase w.
PHwSDTMPhase w Start DatetimeNum
PermThe starting datetime of phase w.
PHwSDTFPhase w Start Date Imputation FlagChar(DATEFL)CondThe level of imputation of the start date for phase w. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
PHwSTMFPhase w Start Time Imputation FlagChar(TIMEFL)CondThe level of imputation of the start time for phase w. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
PHwEDTPhase w End DateNum
PermThe ending date of phase w.
PHwETMPhase w End TimeNum
PermThe ending time of phase w.
PHwEDTMPhase w End DatetimeNum
PermThe ending datetime of phase w.
PHwEDTFPhase w End Date Imputation FlagChar(DATEFL)CondThe level of imputation of the end date for phase w. See Section 2.9.3.3, Date and Time Imputation Flag Variables.
PHwETMFPhase w End Time Imputation FlagChar(TIMEFL)CondThe level of imputation of the end time for phase w. See Section 2.9.3.3, Date and Time Imputation Flag Variables.

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 ADaMIG 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.

  1. 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.
  2. If period timing variables are not included in ADSL, then subperiod timing variables must be excluded from ADSL.
  3. 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.
  4. If all of the variable definitions in the set are the same across all datasets, then they can be included in ADSL. 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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