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| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes | |||||||||||||||||||||||||||||||||||||||||
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| STUDYID | Study Identifier | Char | Req | DM.STUDYID | ||||||||||||||||||||||||||||||||||||||||||
| USUBJID | Unique Subject Identifier | Char | Req | DM.USUBJID | ||||||||||||||||||||||||||||||||||||||||||
| SUBJID | Subject Identifier for the Study | Char | Req | DM.SUBJID | ||||||||||||||||||||||||||||||||||||||||||
| SITEID | Study Site Identifier | Char | Req | DM.SITEID | ||||||||||||||||||||||||||||||||||||||||||
| AGE | Age | Num | Req | DM.AGE. If analysis needs require a derived age that does not match DM.AGE, then AAGE must be added | ||||||||||||||||||||||||||||||||||||||||||
| AGEU | Age Units | Char | (AGEU) | Req | DM.AGEU | |||||||||||||||||||||||||||||||||||||||||
| AGEGRyAGEGR1 | Pooled Age Group y1 | Char | Perm | Character description of a grouping or pooling of the subject's age for analysis purposes. For example, AGEGR1 might have values of "<18", "18-65", and ">65"; AGEGR2 might have values of "Less than 35 y old" and "At least 35 y old". | ||||||||||||||||||||||||||||||||||||||||||
| SEX | Sex | Char | (SEX) | Req | DM.SEX | |||||||||||||||||||||||||||||||||||||||||
| RACE | Race | Char | (RACE) | Req | DM.RACE | RACEGRy | Pooled Race Group y | Char | ||||||||||||||||||||||||||||||||||||||
| Perm | Character description of a grouping or pooling of the subject's race for analysis purposes. | ETHNIC | Ethnicity | Char | Perm | DM.ETHNIC | ||||||||||||||||||||||||||||||||||||||||
| SAFFL | Safety Population Flag | Char | Y; N | Cond | Y if ADSL.TR01SDT TRTSDT is not null, otherwise N | PPROTFL | Per-Protocol Population Flag | Char | Y; NCond | |||||||||||||||||||||||||||||||||||||
| Y if ADSL.SAFFL=Y and at least one post-baseline assessment was done, otherwise N | RANDFL | Randomized Population Flag | Char | Y; N | Cond | Y if the subject was randomized, otherwise N | ||||||||||||||||||||||||||||||||||||||||
| ARM | Description of Planned Arm | Char | Req | DM.ARM | ||||||||||||||||||||||||||||||||||||||||||
| ACTARM | Description of Actual Arm | Char | Perm | DM.ACTARM | ||||||||||||||||||||||||||||||||||||||||||
| TRTxxPTRT01P | Planned Treatment for Period xx01 | Char | Req | Subject-level identifier that represents the planned treatment for period xx. In a one-period randomized trial, TRT01P would be the treatment to which the subject was randomized. TRTxxP might be derived from the SDTM DM variable ARM. At least TRT01P is required. | DM.ARM | |||||||||||||||||||||||||||||||||||||||||
| TRT01PNTRTxxPN | Planned Treatment for Period xx 01 (N) | Num | Perm | Numeric representation of TRTxxP. There must be a one-to-one relationship between TRTxxPN and TRTxxP within a study. TRTxxPN cannot be present unless TRTxxP is also present. When TRTxxP and TRTxxPN are present, then on a given record, either both must be populated or both must be null. | Assigned based on the ARM value | |||||||||||||||||||||||||||||||||||||||||
| TRT01ATRTxxA | Actual Treatment for Period xx01 | Char | Cond | Subject-level identifier that represents the actual treatment for the subject for period xx. Required when actual treatment does not match planned and there is an analysis of the data as treated. | DM.ACTARM | |||||||||||||||||||||||||||||||||||||||||
| TRT01ANTRTxxAN | Actual Treatment for Period xx 01 (N) | Num | Perm | Numeric representation of TRTxxA. There must be a one-to-one relationship between TRTxxAN and TRTxxA within a study. TRTxxAN cannot be present unless TRTxxA is also present. When TRTxxA and TRTxxAN are present, then on a given record, either both must be populated or both must be null. | TRTSEQP | Char | Cond | Required when there is an analysis based on the sequence of treatments, for example in a crossover design. TRTSEQP is not necessarily equal to ARM, for example if ARM contains elements that are not relevant to analysis of treatments or ARM is not fully descriptive (e.g., "GROUP 1," "GROUP 2"). When analyzing based on the sequence of treatments, TRTSEQP is required even if identical to ARM. Assigned based on the ACTARM value | ||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Numeric version of RFXSTDTC | ||||||||||||||||||||||||||||||||||||
| 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. | 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. | 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. | TRxxEDT | Date of Last Exposure in Period xx | Num | Cond | Date of last exposure to treatment in period xx. TRxxEDT and/or TRxxEDTM are only required in trial designs where multiple treatment periods are defined (i.e., required when there is a TRTxxP other than TRT01P). | Numeric version of RFXENDTC | ||||||||||||||||||||||||||
| 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. | 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 | 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"). | |||||||||||||||||||||||||||||||||||||
| 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. | 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. | 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. | DTHDT | Date of Death | Num | Perm | Date of subject's death. Derived from DM.DTHDTC. | DTHCAUS | Cause of Death | Char | Perm | Cause of Death. | STRATAR | Strata Used for Randomization | Char | Perm | STRATAR contains the combination of values of the individual stratification factors used for randomization. The exact format should be determined by the sponsor. This variable is intended for studies that use stratified randomization. For example, ">=50, Treatment experienced, N" | STRATAV | Strata from Verification Source | Char | Perm | STRATAV contains the entire string value represents the combination of values of the individual stratification factors that should have been used and represents the "as verified" value. The STRATAV variables are based on the source documentation and are determined after randomization. If the values used for the randomization of a given subject were all correct, then STRATAV will equal STRATAR. Otherwise, one or more components of the text string for STRATAR and STRATAV will be different. The exact format should be determined by the sponsor. For example, ">=50, Treatment experienced, Y" | DS.DSSTDTC where DSDECOD=RANDOMIZED |
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