Page History

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

EOSSTT

End of Study Status

Char

(SBJTSTAT)

Perm

The subject's status as of the end of study or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING.

EOSDT

End of Study Date

Num

Perm

Date subject ended the study - either date of completion or date of discontinuation or data cutoff date for interim analyses.

DCSREAS

Reason for Discontinuation from Study

Char

Perm

Reason for subject's discontinuation from study. The source would most likely be the SDTM DS dataset. Null for subjects who completed the study.

DCSREASP

Reason Spec for Discont from Study

Char

Perm

Additional detail regarding subject's discontinuation from study (e.g., description of "other").

EOTSTT

End of Treatment Status

Char

(SBJTSTAT)

Perm

The subject's status as of the end of treatment or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING.

DCTREAS

Reason for Discontinuation of Treatment

Char

Perm

If a subject discontinued treatment in the study, then this variable indicates the reason for discontinuation. This is for discontinuation of treatment in the overall study and not to be used for discontinuation reason within individual treatment periods.

DCTREASP

Reason Specify for Discont of Treatment

Char

Perm

Additional detail regarding subject's discontinuation from treatment (e.g., description of "other").

EOTxxSTT

End of Treatment Status in Period xx

Char

(SBJTSTAT)

Perm

The subject's treatment status as of the end of period xx, or data cutoff if within period xx. Examples: COMPLETED, DISCONTINUED, ONGOING.

DCTxxRS

Reason for Discont of Treat in Period xx

Char

Perm

Reason for discontinuing treatment in period xx.

DCTxxRSP

Reason Spec for Disc of Trt in Period xx

Char

Perm

Additional detail regarding subject's discontinuation of treatment in period xx (e.g., description of "other").

EOPxxSTT

End of Period xx Status

Char

(SBJTSTAT)

Perm

The subject's status as of the end of period xx, or data cutoff if within period xx. Examples: COMPLETED, DISCONTINUED, ONGOING.

DCPxxRS

Reason for Discont from Period xx

Char

Perm

Reason for discontinuing analysis period xx.

DCPxxRSP

Reason Spec for Discont from Period xx

Char

Perm

Additional detail regarding subject's discontinuation from period xx (e.g., description of "other").

RFICDT

Date of Informed Consent

Num

Perm

Date subject gave informed consent. Generally equivalent to DM.RFICDTC.

ENRLDT

Date of Enrollment

Num

Perm

Date of subject's enrollment into trial.

RANDDT

Date of Randomization

Num

Cond

Required in randomized trials.

RFICyDT

Date of Informed Consent y

Num

Perm

This variable may be used in the case where there are multiple consent dates within a study. This date does not need to repeat the date in RFICDT. "y" can start with 1 but it is not required to start with 1.

ENRLyDT

Date of Enrollment y

Num

Perm

This variable may be used in the case where there are multiple enrollment dates within a study. This date does not need to repeat the date in ENRLDT. "y" can start with 1 but it is not required to start with 1.

RANDyDT

Date of Randomization y

Num

Perm

This variable may be used in the case where there are multiple randomization dates within a study. This date does not need to repeat the date in RANDDT. "y" can start with 1 but it is not required to start with 1.

LSTALVDT

Date Last Known Alive

Num

Perm

If this variable is included in ADSL, the best practice is to populate it for everyone. If the derivation for

subjects who died differs from the derivation for subjects who are not known to have died, the differences should be noted in metadata.

TRCMP

Treatment Compliance (%)

Num

Perm

Overall percent compliance with treatment in the trial. TRCMP may be useful for inclusion in ADSL for reasons such as defining subgroups and/or populations.

TRCMPGy

Treatment Compliance (%) Group y

Char

Perm

Grouping "y" of TRCMP, treatment compliance percentage.

TRCMPGyN

Treatment Compliance (%) Group y (N)

Num

Perm

Numeric representation of treatment compliance (%) grouping "y". There must be a one-to-one relationship between TRCMPGyN and TRCMPGy within a study.

TRCMPGyN cannot be present unless TRCMPGy is also present. When TRCMPGy and TRCMPGyN are present, then on a given record, either both must be populated or both must be null.

TRxxDURD

Treatment Duration in Period xx (Days)

Num

Perm

Treatment duration for period xx as measured in days. More than one of TRxxDURD, TRxxDURM, and TRxxDURY can be populated, but each represents the entire duration in its respective units.

TRxxDURM

Treatment Duration in Period xx (Months)

Num

Perm

Treatment duration for period xx, as measure in months. More than one of TRxxDURD, TRxxDURM, and TRxxDURY can be populated, but each represents the entire duration in its respective units.

TRxxDURY

Treatment Duration in Period xx (Years)

Num

Perm

Treatment duration for period xx, as measured in years. More than one of TRxxDURD, TRxxDURM, and TRxxDURY can be populated, but each represents the entire duration in its respective units.

TRTDURD

Total Treatment Duration (Days)

Num

Perm

Total treatment duration, as measured in days. More than one of TRTDURD, TRTDURM, and TRTDURY can be populated, but each represents the entire duration in its respective units.

TRTDURM

Total Treatment Duration (Months)

Num

Perm

Total treatment duration, as measured in months. More than one of TRTDURD, TRTDURM, and TRTDURY can be populated, but each represents the entire duration in its respective units.

TRTDURY

Total Treatment Duration (Years)

Num

Perm

Total treatment duration, as measured in years. More than one of TRTDURD, TRTDURM, and TRTDURY can be populated, but each represents the entire duration in its respective units.

DTHDT

Date of Death

Num

Perm

Date of subject's death. Derived from DM.DTHDTC.

DTHDTF

Date of Death Imputation Flag

Char

(DATEFL)

Cond

Imputation flag for date of subject's death. If DTHDT was imputed, DTHDTF must be populated and is required. See ADD LINK Section 3.1.3, Date and Time Imputation Flag Variables.

DTHCAUS

Cause of Death

Char

Perm

Cause of Death.

DTHCAUSN

Cause of Death (N)

Num

Perm

Numeric representation of cause of death. There must be a one-to-one relationship between DTHCAUSN and DTHCAUS within a study.

DTHCAUSN cannot be present unless DTHCAUS is also present. When DTHCAUS and DTHCAUSN are present, then on a given record, either both must be populated or both must be null.

DTHCGRy

Cause of Death Group y

Char

Perm

Grouping "y" of DTHCAUS, the subject's cause of death.

DTHCGRyN

Cause of Death Group y (N)

Num

Perm

Numeric representation of grouping "y" of the subject's cause of death. There must be a one-to-one relationship between DTHCGRyN and DTHCGRy within a study.

DTHCGyN cannot be present unless DTHCGy is also present. When DTHCGy and DTHCGyN are present, then on a given record, either both must be populated or both must be null.