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Variable NameVariable LabelTypeCodelist/Controlled TermsCoreCDISC Notes

STUDYID

Study IdentifierChar
ReqLB.STUDYID
USUBJIDUnique Subject IdentifierChar
ReqLB.USUBJID
TRTPPlanned TreatmentChar
CondADSL.TRT01P
TRT01PPlanned Treatment for Period 01Char
CondADSL.TRT01P
TRTAActual TreatmentChar
CondADSL.TRT01A
TRTx01AActual Treatment for Period 01Char
CondADSL.TRT01A
ADTAnalysis DateNum
PermLB.LBDTC captured in numeric format
ADYAnalysis Relative DayNum
PermLB.LBDY
AVISITAnalysis VisitChar
CondLB.VISIT
AVISITNAnalysis Visit (N)Num
PermLB.VISITNUM
PARAMParameterChar
ReqLB.LBTEST concatenated with LB.LBSTRESU - if PARCAT1=URINALYSIS then preface with Urine
PARAMCDParameter Codetext
ReqLB.LBTESTCD - if PARCAT1=URINALYSIS then preface with U
PARAMNParameter (N)Num
PermNumeric representation of PARAM. Sort by PARCAT! and PARAMCD and increment by 1 for each new LBTESTCD
PARCAT1Parameter Category 1Char
PermLB.LBCAT
AVALAnalysis ValueNum
CondLB.LBSTRESN
AVALCAnalysis Value (C)Char
CondLB.LBSTRESC where LB.LBSTRESN is null
BASEBaseline ValueNum
CondAVAL where ABLFL=Y
CHGChange from BaselineNum
PermAVAL-BASE - populated on ABLFL=Y records and post-baseline records
PCHGPercent Change from BaselineNum
Permderived as ((AVAL-BASE)/BASE)*100
ABLFLBaseline Record FlagCharYCondset to Y for last pre-treatment value within each PARAM
ANL01FLAnalysis Flag 01CharYCondset to Y for last value within PARAM and AVISIT
RANDFLRandomized Population FlagCharY;NCondADSL.RANDFL
SAFFLSafety Population FlagCharY;NCondADSL.SAFFL
TRTSDTDate of First Exposure to TreatmentNum
PermADSL.TRTSDT
TRTEDTDate of Last Exposure to TreatmentNum
PermADSL.TRTEDT
LBSEQSequence NumberNum
PermLB.LBSEQ
VISITNUMVisit NumberNum
PermLB.VISITNUM
LBDTCDate/Time of Specimen CollectionChar
PermLB.LBDTC

STUDYID

USUBJID

TRTP

TRT01P

TRTA

TRT01A

ADT

ADY

AVISIT

AVISITN


PARAM

PARAMCD

PARAMN

PARCAT1

AVAL

AVALC

BASECHGPCHGABLFLANL01FLLBSTNRCANRLOANRHIANRINDLBLOINCLBSPECRANDFLSAFFLLBCLSIG

LBSEQ

VISITNUM

LBDTC

A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021

-6

SCREENING1
Leukocytes (10^9/L)WBC 6HEMATOLOGY11.0
11.0

YY
4.511.0
26464-8BLOODYY
112021-01-02
A123001-001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1
RBC (10^12/L)RBC8HEMATOLOGY5.4
5.4

YY
4.76.1
33051-4BLOODYY
212021-01-02
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1
Platelets (10^9/L)PLAT7HEMATOLOGY158
158

YY
150400
49497-1BLOODYY
312021-01-02
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1
Hemoglobin (g/dL)HGB5HEMATOLOGY14.5
14.5

YY
1418
718-7BLOODYY
412021-01-02
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1
Cholesterol (mg/dL)CHOL2CLINICAL CHEMISTRY229
229

YY
200

2093-3BLOODYY
512021-01-02
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1
Albumin (g/L)ALB1CLINICAL CHEMISTRY4.0
4.0

YY
3.45.4
2862-1BLOODYY
612021-01-02
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1
Creatinine (mg/dL)CREAT3CLINICAL CHEMISTRY0.8
0.8

YY
0.71.3
2160-0BLOODYY
712021-01-02
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021

-6

SCREENING1
Urine Specific GravityUSPGRAV9URINALYSIS




YY
1.0051.030
2965-2URINEYY
812021-01-02
A123A2001PlaceboPlaceboPlaceboPlacebo02JAN2021-6SCREENING1
CannabinoidsCANNAB4DRUG TOXICITY
POSITIVE




NEGATIVE

ABNORMAL18282-4URINEYYY912021-01-02
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