Subject-Level Period, Subperiod, and Phase Timing Variables for ADSL Datasets

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.