| Variable | Label | Type | Contorlld Term | Role
| Comments/Notes
|
| USUBJID | Unique Subject Identifier
| text | - | Identifier | - |
| VISITNUM | Visit Number | float | - | Timing | - |
| LBTESTCD | Lab Test or Examination Short Name
| text | LBTESTCD | Identifier | Excludes PROTEIN, CHLORIDE, URATE, UREA NITROGEN, CHOLESTEROL GAMMA GLUTAMYL TRANSFERASE to accomodate data set size restrictions on the site |
| STUDYID | Study Identifier
| text | - | Identifier | - |
| DOMAIN | Domain Abbreviation
| text | - | Identifier | - |
| SUBJID | Subject Identifier for the Study
| text | - | Identifier | - |
| VISIT | Visit Name
| text | - | Timing | - |
| ANLDY | Analysis Day
| float | - | Timing | - |
| LBDT | Date of Specimen Collection
| date | - | Timing | - |
| LBTYPE | Type of Lab Test (Hem, Chem)
| text | LBTYPE | Selection | - |
| LBTEST | Lab Test or Examination Name
| text | LBTESTCD | Identifier | Excludes PROTEIN, CHLORIDE, URATE, UREA NITROGEN, CHOLESTEROL GAMMA GLUTAMYL TRANSFERASE to accomodate data set size restrictions on the site |
| LBBLFL | Baseline Flag
| text | Y_BLANK | Selection | - |
| ONTRTFL | On or Off Study Treatment Flag
| text | YNONLY | Support | - |
| ENTMTFL | End of Treatment Flag
| text | Y_BLANK | Selection | - |
| BLTRFL | Baseline Result Abnormal, threshold range
| text | LMH | Analysis | - |
| LBNRIND | Refernce Range Indicator
| text | - | Analysis | - |
| LBTRFL | Result Abnormal, threshold range
| text | LMH | Analysis | - |
| LBTRMXFL | Most Extreme, based on threshold range
| text | Y_BLANK | Selection Analysis
| - |
| LBPRFL | Result Abnormal, compared to previous visit
| text | LMH | Analysis | - |
| LBPRMXFL | Most Extreme, comparison to previous visit
| text | Y_BLANK | Selection Analysis
| - |
| LBSTRESC | Character Result/Finding in Std Format
| text | - | Analysis | - |
| LBSTRESN | Numeric Result/Finding in Std Units
| float | - | Analysis | - |
| LBSTRESU | Standard Units | text | - | Support | - |
| BLSTRESN | Baseline Result
| float | - | Analysis | - |
| BLTMSLO | Baseline Times LLN
| float | - | Analysis | - |
| BLTMSHI | Baseline Times ULN
| float | - | Analysis | - |
| CHSTRESN | Result Change from Baseline
| float | - | Analysis | - |
| LBTMSLO | Result Times Lower Limit of Normal
| float | - | Analysis | - |
| LBTMSHI | Result Times Upper Limit of Normal
| float | - | Analysis | - |
| LBTRVAL | Amount Threshold Range
| float | - | Support | - |
| PRSTRESN | Previous Visit Result
| float | - | Analysis | - |
| LBPRRESN | Change from Previous Visit, relative to
| float | - | Support | - |
| PRSTRESN | Previous Visit Result
| float | - | Analysis | - |
| LBPRRESN | Change from Previous Visit, relative to
| float | - | Support | - |
| PRTMSLO | Previous Times LLN | float | - | Analysis | - |
| PRTMSHI | Previous Times ULN
| float | - | Analysis | - |
| TRTP | ADaM Description of Planned Arm
| text | ARM | Analysis | - |
| TRTPCD | ADaM Planned Arm Code
| text | ARMCD | Analysis | - |
| TRTPN | ADam Planned Arm Code, Numeric
| float | ARMCDN | Analysis | - |
| AGE | Age in AGEU at RFSTDTC
| float | - | Covariate | AGEU in Years
|
| AGEGRP | Age Group
| text | AGEGRP | Covariate | -
|
| AGEGRPN | Age Group, Numeric
| float | AGEGRPN | Covariate | - |
| RACE | Race | text | ADRACE | Covariate | - |
| RACEN | Race, Numeric
| float | ADRACEN | Covariate | - |
| SEX | Sex | text | SEX | Covariate Selection
| - |
| BLLO | Baseline LLN
| float | - | Analysis | - |
| BLHI | Baseline ULN
| float | - | Analysis | - |
| LBSTNRLO | Reference Range Lower Limit - Std Units
| float | - | Analysis | - |
| LBSTNRHI | Reference Range Upper Limit - Std Units
| float | - | Analysis | - |
| PRLO | Previous LLN
| float | - | Analysis | - |
| PRHI | Previous ULN
| float | - | Analysis | - |
| SAFETY | Safety Population Flag
| text | YNONLY | Selection | - |
| ITT | Intent to Treat Population Flag
| text | YNONLY | Selection | - |
| EFFICACY | Efficacy Population Flag
| text | YNONLY | Selection | - |
| COMPLT24 | Completer of Week 24 Population Flag
| text | YNONLY | Selection | - |
| DSREASAE | Discontinued Due to AE?
| text | Y_BLANK | Selection | - |
| RANDDT | Date of Randomization (Visit 3)
| date | - | Support | - |
| TRTSTDT | Start Date of Treatment | date | - | Support | - |
| LSTDOSDT | Date of Last Dose
| date | - | Support | |
| TRTDUR | Duration of Treatment
| float | - | Support | In days |