| ROWORDER | VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT |
|---|---|---|---|---|
| 001 | STUDYID | Study Identifier | Char | DM.STUDYID |
| 002 | USUBJID | Unique Subject Identifier | Char | DM.USUBJID |
| 003 | SUBJID | Subject Identifier for the Study | Char | DM.SUBJID |
| 004 | SITEID | Study Site Identifier | Char | DM.SITEID |
| 005 | AGE | Age | Num | DM.AGE |
| 006 | AGEU | Age Units | Char | DM.AGEU |
| 007 | 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". |
| 008 | 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. |
| 009 | SEX | Sex | Char | DM.SEX |
| 010 | RACE | Race | Char | DM.RACE |
| 011 | RACE1 | Race 1 | Char | Populate using QVAL where SUPPDM.QNAM="RACE1" |
| 012 | RACE2 | Race 2 | Char | Populate using QVAL where SUPPDM.QNAM="RACE2" |
| 013 | RACESP | Race Other Specify | Char | Populate using QVAL where SUPPDM.QNAM="RACESP" |
| 014 | SAFFL | Safety Population Flag | Char | Populate as "Y" for the subjects with non missing treatment start date (ADSL.TRTSDT). Else populate as "N". |
| 015 | 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". |
| 016 | RANDFL | Randomized Population Flag | Char | Populate as "Y" for the subjects with non missing randomization date (ADSL.RANDDT). Else populate as "N". |
| 017 | ENRLFL | Enrolled Population Flag | Char | Populate as "Y" for the subjects with non missing enrollment date (ADSL.ENRLDT). Else populate as "N". |
| 018 | ARM | Description of Planned Arm | Char | DM.ARM |
| 019 | ACTARM | Description of Actual Arm | Char | DM.ACTARM |
| 020 | 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. |
| 021 | 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.. |
| 022 | 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. |
| 023 | 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.. |
| 024 | TRTSDT | Date of First Exposure to Treatment | Num | ADSL.TR01SDT |
| 025 | TRTEDT | Date of Last Exposure to Treatment | Num | ADSL.TR01EDT |
| 026 | TR01SDT | Date of First Exposure in Period 01 | Num | Populate using DM.RFXSTDTC |
| 027 | TR01EDT | Date of Last Exposure in Period 01 | Num | Populate using DM.RFXENDTC |
| 028 | 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". |
| 029 | EOSDT | End of Study Date | Num | Populate using DS.DSSTDTC from the record where DS.DSSCAT="END OF STUDY". |
| 030 | 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"). |
| 031 | 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". |
| 032 | 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"). |
| 033 | RFICDT | Date of Informed Consent | Num | Populate using DM.RFICDTC, after converting the date portion to numeric version. |
| 034 | ENRLDT | Date of Enrollment | Num | Populate using DS.DSSTDTC on the record where DSTERM="ENROLLED" |
| 035 | RANDDT | Date of Randomization | Num | Populate using DS.DSSTDTC on the record where DSDECOD="RANDOMIZED" |
| 036 | LSTALVDT | Date Last Known Alive | Num | Populate using DM.RFPENDTC |
| 037 | TRTDURD | Total Treatment Duration (Days) | Num | Populate as the difference between TRTEDT-TRTSDT+1. |
| 038 | DTHDT | Date of Death | Num | Populate using DM.DTHDTC. |
| 039 | HEIGHTBL | Baseline Height (cm) | Num | Populate using VS.VSSTRESN where VS.VSTESTCD="HEIGHT" and VS.VSBLFL="Y". |
| 040 | WEIGHTBL | Baseline Weight (kg) | Num | Populate using VS.VSSTRESN where VS.VSTESTCD="WEIGHT" and VS.VSBLFL="Y". |