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Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

TRTSDT

Date of First Exposure to Treatment

Num

Cond

Date of first exposure to treatment for a subject in a study. TRTSDT and/or TRTSDTM are required if there is an investigational product. Note that TRTSDT is not required to have the same value as the SDTM DM variable RFXSTDTC. While both of these dates reflect the concept of first exposure, the ADaM date may be derived to support the analysis which may not necessarily be the very first date in the

SDTM EX domain.

TRTSTM

Time of First Exposure to Treatment

Num

Perm

Time of first exposure to treatment for a subject in a study.

TRTSDTM

Datetime of First Exposure to Treatment

Num

Cond

Datetime of first exposure to treatment for a subject in a study. TRTSDT and/or TRTSDTM are required if there is an investigational product.

TRTSDTF

Date of First Exposure Imput. Flag

Char

(DATEFL)

Cond

The level of imputation of date of first exposure to treatment. If TRTSDT (or the date part of TRTSDTM) was imputed, TRTSDTF must be populated and is required. See ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.

TRTSTMF

Time of First Exposure Imput. Flag

Char

(TIMEFL)

Cond

The level of imputation of time of first exposure to treatment. If TRTSTM (or the time part of TRTSDTM) was imputed, TRTSTMF must be populated and is required. See ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.

TRTEDT

Date of Last Exposure to Treatment

Num

Cond

Date of last exposure to treatment for a subject in a study. TRTEDT and/or TRTEDTM are required if there is an investigational product. Note that TRTEDT is not required to have the same value as the SDTM DM variable RFXENDTC. While both of these dates reflect the concept of last exposure, the ADaM date may be derived to support the analysis which may not necessarily be the very last date in the SDTM EX domain.

TRTETM

Time of Last Exposure to Treatment

Num

Perm

Time of last exposure to treatment for a subject in a study.

TRTEDTM

Datetime of Last Exposure to Treatment

Num

Cond

Datetime of last exposure to treatment for a subject in a study. TRTEDT and/or TRTEDTM are required if there is an investigational product.

TRTEDTF

Date of Last Exposure Imput. Flag

Char

(DATEFL)

Cond

The level of imputation of date of last exposure to treatment. If TRTEDT (or the date part of TRTEDTM) was imputed, TRTEDTF must be populated and is required. See ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.

TRTETMF

Time of Last Exposure Imput. Flag

Char

(TIMEFL)

Cond

The level of imputation of time of last exposure to treatment. If TRTETM (or the time part of TRTEDTM)

was imputed, TRTETMF must be populated and is required. See ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.

TRxxSDT

Date of First Exposure in Period xx

Num

Cond

Date of first exposure to treatment in period xx. TRxxSDT and/or TRxxSDTM are only required in trial designs where multiple treatment periods are defined (i.e., required when there is a TRTxxP other than TRT01P). Examples include crossover designs or designs where multiple periods exist for the same

treatment.

TRxxSTM

Time of First Exposure in Period xx

Num

Cond

Starting time of exposure to treatment in period xx. TRxxSTM and/or TRxxSDTM are only required in trial

designs where starting time is important to the analysis and multiple treatment periods are defined (i.e., required when there is a TRTxxP other than TRT01P).