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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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APxxSDT

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Period xx Start Date

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Num

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Perm

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The starting date of period xx.

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APxxSTM

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Period xx Start Time

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Num

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Perm

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The starting time of period xx.

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APxxSDTM

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Period xx Start Datetime

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Num

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Perm

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The starting datetime of period xx.

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APxxSDTF

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Period xx Start Date 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 period xx start date. See Date and Time Imputation Flag Variables.

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APxxSTMF

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Period xx Start Time 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 period xx start time. See Date and Time Imputation Flag Variables.

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APxxEDT

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Period xx End Date

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Num

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Perm

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The ending date of period xx.

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APxxETM

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Period xx End Time

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Num

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Perm

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The ending time of period xx.

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APxxEDTM

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Period xx End Datetime

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Num

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Perm

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The ending datetime of period xx.

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APxxEDTF

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Period xx End Date 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 period xx end date. See Date and Time Imputation Flag Variables.

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APxxETMF

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Period xx End Time 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 period xx end time. See Date and Time Imputation Flag Variables.

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PxxSw

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Description of Period xx Subperiod w

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Char

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Perm

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Description of analysis subperiod w within period xx.

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PxxSwSDT

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Period xx Subperiod w Start Date

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Num

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Perm

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The starting date of subperiod w within period xx.

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PxxSwSTM

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Period xx Subperiod w Start Time

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Num

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Perm

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The starting time of subperiod w within period xx.

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PxxSwSDM

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Period xx Subperiod w Start Datetime

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Num

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Perm

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The starting datetime of subperiod w within period xx.

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PxxSwSDF

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Period xx Subper w Start Date 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 the start date for subperiod w within period xx. See Date and Time Imputation Flag Variables.

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PxxSwSTF

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Period xx Subper w Start Time 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 the start time for subperiod w within period xx. See Date and Time Imputation Flag Variables.

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PxxSwEDT

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Period xx Subperiod w End Date

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Num

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Perm

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The ending date of subperiod w within period xx.

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PxxSwETM

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Period xx Subperiod w End Time

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Num

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Perm

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The ending time of subperiod w within period xx.

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PxxSwEDM

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Period xx Subperiod w End Datetime

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Num

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Perm

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The ending datetime of subperiod w within period xx.

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PxxSwEDF

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Period xx Subper w End Date 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 the end date for subperiod w within period xx. See Date and Time Imputation Flag Variables.

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PxxSwETF

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Period xx Subper w End Time 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 the end time for subperiod w within period xx. See Date and Time Imputation Flag Variables.

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APHASEw

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Description of Phase w

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Char

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Perm

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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.

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PHwSDT

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Phase w Start Date

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Num

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Perm

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The starting date of phase w.

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PHwSTM

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Phase w Start Time

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Num

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Perm

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The starting time of phase w.

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PHwSDTM

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Phase w Start Datetime

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Num

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Perm

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The starting datetime of phase w.

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PHwSDTF

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Phase w Start Date Imputation 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 the start date for phase w. See Date and Time Imputation Flag Variables.

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PHwSTMF

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Phase w Start Time Imputation 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 the start time for phase w. See Date and Time Imputation Flag Variables.

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PHwEDT

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Phase w End Date

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Num

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Perm

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The ending date of phase w.

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PHwETM

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Phase w End Time

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Num

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Perm

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The ending time of phase w.

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PHwEDTM

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Phase w End Datetime

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Num

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Perm

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The ending datetime of phase w.

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PHwEDTF

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Phase w End Date Imputation 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 the end date for phase w. See Date and Time Imputation Flag Variables.

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PHwETMF

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Phase w End Time Imputation 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 the end time for phase w. See Date and Time Imputation Flag Variables.

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