myCSG © |Area: ADaM| Concept: ADSL : Full ADSL - Subject Level Analysis Dataset | Lesson: L1101 : ADSL dataset for a parallel arm study - statschoice-001 |

Complete ADSL program for a one period parallel arm study

Includes variables based on SDTM DM, SUPPDM, DS, VS
Includes baseline variables - height and weight

Includes key date variables - enrollment date, informed consent date, randomization date, treatment start date, treatment end date, end of study date, date last known to be aliveIncludes treatment and study status variables - eotstt and eosstt
Includes grouping variables - AGEGR1 and AGEGR1N
Includes treatment duration variable - TRTDURD

Includes subject level population flags - ENRLFL, RANDFL, SAFFL

Includes subject level treatment variables - TRT01P, TRT01PN, TRT01A, TRT01AN

VARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENT
STUDYID Study Identifier Char DM.STUDYID
USUBJID Unique Subject Identifier Char DM.USUBJID
SUBJID Subject Identifier for the Study Char DM.SUBJID
SITEID Study Site Identifier Char DM.SITEID
AGE Age Num DM.AGE
AGEU Age Units Char DM.AGEU
AGEGR1 Pooled Age Group 1 Char Populate using DM.AGE. If AGE<60 then set to "< 60 Years". Else if AGE>=60 then set to ">= 60 Years".
AGEGR1N Pooled Age Group 1 (N) Num Populate using ADSL.AGEGR1. If AGEGR1="< 60 Years" then set to 1. Else if AGEGR1=">= 60 Years" then set to 2.
SEX Sex Char DM.SEX
RACE Race Char DM.RACE
RACE1 Race 1 Char Populate using QVAL where SUPPDM.QNAM="RACE1"
RACE2 Race 2 Char Populate using QVAL where SUPPDM.QNAM="RACE2"
RACESP Race Other Specify Char Populate using QVAL where SUPPDM.QNAM="RACESP"
SAFFL Safety Population Flag Char Populate as "Y" for the subjects with non missing treatment start date (ADSL.TRTSDT). Else populate as "N".
COMPLFL Completers Population Flag Char Populate as "Y" for the subjects who completed the study (DS.DSSCAT="END OF STUDY" and DS.DSDECOD="COMPLETED"). Else populate as "N".
RANDFL Randomized Population Flag Char Populate as "Y" for the subjects with non missing randomization date (ADSL.RANDDT). Else populate as "N".
ENRLFL Enrolled Population Flag Char Populate as "Y" for the subjects with non missing enrollment date (ADSL.ENRLDT). Else populate as "N".
ARM Description of Planned Arm Char DM.ARM
ACTARM Description of Actual Arm Char DM.ACTARM
TRT01P Planned Treatment for Period 01 Char Populate using DM.ARM. If ARM="Placebo" then "Placebo". Else if ARM="Active" then "Active". Else set to null.
TRT01PN Planned Treatment for Period 01 (N) Num Populate using ADSL.TRT01P. If TRT01P="Placebo" then set to 1. Else if TRT01P="Active" then set to 2..
TRT01A Actual Treatment for Period 01 Char Populate using DM.ACTARM. If ARM="Placebo" then "Placebo". Else if ACTARM="Active" then "Active". Else set to null.
TRT01AN Actual Treatment for Period 01 (N) Num Populate using ADSL.TRT01A. If TRT01P="Placebo" then set to 1. Else if TRT01A="Active" then set to 2..
TRTSDT Date of First Exposure to Treatment Num ADSL.TR01SDT
TRTEDT Date of Last Exposure to Treatment Num ADSL.TR01EDT
TR01SDT Date of First Exposure in Period 01 Num Populate using DM.RFXSTDTC
TR01EDT Date of Last Exposure in Period 01 Num Populate using DM.RFXENDTC
EOSSTT End of Study Status Char Populate using the end of study status record in disposition data (DS.DSSCAT="END OF STUDY").
If DSDECOD="COMPLETED" then set to "COMPLETED".
Else if DSDECOD is not null then set to "DISONTINUED".
Else if no record exists in disposition for end of study status and subject is not screen failure (ADSL.ARM is not "Screen Failure"), then set to "ONGOING".
EOSDT End of Study Date Num Populate using DS.DSSTDTC from the record where DS.DSSCAT="END OF STUDY".
DCSREAS Reason for Discontinuation from Study Char Populate using DS.DSDECOD form the end of study status record in disposition data (DS.DSSCAT="END OF STUDY" and DS.DSDECOD is not "COMPLETED").
EOTSTT End of Treatment Status Char Populate using the end of study treatment record in disposition data (DS.DSSCAT="END OF TREATMENT").
If DSDECOD="COMPLETED" then set to "COMPLETED".
Else if DSDECOD is not null then set to "DISONTINUED".
Else if no record exists in disposition for end of treatment status and subject is a safety subject (ADSL.SAFFL="Y"), then set to "ONGOING".
DCTREAS Reason for Discontinuation of Treatment Char Populate using DS.DSDECOD form the end of study status record in disposition data (DS.DSSCAT="END OF TREATMENT" and DS.DSDECOD is not "COMPLETED").
RFICDT Date of Informed Consent Num Populate using DM.RFICDTC, after converting the date portion to numeric version.
ENRLDT Date of Enrollment Num Populate using DS.DSSTDTC on the record where DSTERM="ENROLLED"
RANDDT Date of Randomization Num Populate using DS.DSSTDTC on the record where DSDECOD="RANDOMIZED"
LSTALVDT Date Last Known Alive Num Populate using DM.RFPENDTC
TRTDURD Total Treatment Duration (Days) Num Populate as the difference between TRTEDT-TRTSDT+1.
DTHDT Date of Death Num Populate using DM.DTHDTC.
HEIGHTBL Baseline Height (cm) Num Populate using VS.VSSTRESN where VS.VSTESTCD="HEIGHT" and VS.VSBLFL="Y".
WEIGHTBL Baseline Weight (kg) Num Populate using VS.VSSTRESN where VS.VSTESTCD="WEIGHT" and VS.VSBLFL="Y".
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