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ADSL Period, Subperiod, and Phase Timing Variables

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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, 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 ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.


Additional timing variables can be included for phase, period, and subperiod (APHASE, APERIOD, and ASPER, defined in ADD LINKS Table 3.3.3.1). Table 3.2.7 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.

  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 ADD LINK Table 3.2.7. 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
  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 ADD LINK Table 3.3.3.2 specifies variables to be used in the other datasets when definitions differ by dataset.
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