Variable Name,Variable Label,Type,Codelist/ Controlled Terms,Core,CDISC Notes
EOSSTT,End of Study Status,Char,,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,,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,,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,,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 version of treatment compliance (%) grouping ‘y’. Must have a one-to-one mapping to TRCMPGy.
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,,Cond,"Imputation flag for date of subject’s death. If DTHDT was imputed, DTHDTF must be populated
and is required. See Section 3.1.3."
DTHCAUS,Cause of Death,Char,,Perm,Cause of Death.
DTHCAUSN,Cause of Death (N),Num,,Perm,Numeric representation of cause of death. Must have a one-to-one mapping to DTHCAUS.
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 version of grouping ‘y’ of the subject’s cause of death. Must have a one-to-one mapping
to DTHCGRy."
