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Dataset wrap
Nameadlb
Dataset2
tableidadlb
RowSTUDYIDUSUBJID
LBSEQ
TRTPADTADTMAENDTMAVISITAVISITNPARAMCDPARAMPARCAT1AVAL
BASE
ABLFLSAFFL
CHG
TRTSDT
ABLFL
TRTEDTLBSTRESNLBSTRESULBNAMLBLOINCLBSPECLBMETHODLBLOBXFLLBLLOQVISITNUMVISITLBDTCLBENDTCLBSEQ
1TOB777001
Product A17JAN2021

Baseline0
1
NICOTINENicotine (ng/mL)TOBACCO ALKALOID30YY2021-01-202021-12-2030ng/mLTobacco Marker Testing Laboratory3853-9SERUMLC/MS/MSY21BASELINE2021-01-17
1
2TOB777001
2
Product A20JUL2021

Day 180180COTININECotinine (ng/mL)TOBACCO ALKALOID400
Y2021-01-202021-12-20400ng/mLTobacco Marker Testing Laboratory10365-5SERUMLC/MS/MS
23Day 1802021-07-20
2
3TOB777002
Product A21JUN202121JUN2021:08:0022JUN2021:08:00Baseline0
1
CREATCreatinine (ng/mL)24-HOUR URINE TEST0.8YY2021-01-202021-12-200.8ng/mLTobacco Marker Testing Laboratory65634-8URINELC-MS-MSY
1BASELINE2021-06-21T08:002021-06-22T08:001
4TOB777002
Product A21JUN202121JUN2021:08:0022JUN2021:08:00Baseline0
2
VOLUMEVolume (mL)24-HOUR URINE TEST1875YY2021-01-202021-12-201875mLTobacco Marker Testing Laboratory
URINE
Y
1BASELINE2021-06-21T08:002021-06-22T08:002
5TOB777002
3
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180NICOTINENicotine (ng/mL)TOBACCO ALKALOID45
Y2021-01-202021-12-2045ng/mLTobacco Marker Testing Laboratory3854-7URINELC-MS/MS
0.23Day 1802021-12-15T08:002021-12-16T08:003
6TOB777002
4
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180NICGLUCNicotine-glucuronide (ng/mL)TOBACCO ALKALOID40
Y2021-01-202021-12-2040ng/mLTobacco Marker Testing Laboratory
URINE

0.23Day 1802021-12-15T08:002021-12-16T08:004
7TOB777002
5
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180NOXTNicotine-1 N-oxid (ng/mL)TOBACCO ALKALOID113.5
Y2021-01-202021-12-20113.5ng/mLTobacco Marker Testing Laboratory
URINEHPLC-ESI-MS/MS
2.503Day 1802021-12-15T08:002021-12-16T08:005
8TOB777002
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180
6
COTININECotinine (ng/mL)TOBACCO ALKALOID300
Y2021-01-202021-12-20300ng/mLTobacco Marker Testing Laboratory10366-3URINELC/MS/MS)
0.053Day 1802021-12-15T08:002021-12-16T08:006
9TOB777002
7
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180COTGLUCCotinine-glucuronide (ng/mL)TOBACCO ALKALOID275
Y2021-01-202021-12-20275ng/mLTobacco Marker Testing Laboratory
URINE

0.23Day 1802021-12-15T08:002021-12-16T08:007
10TOB777002
8
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180COXTCotinine-n-oxide (ng/mL)TOBACCO ALKALOID117.5
Y2021-01-202021-12-20117.5ng/mLTobacco Marker Testing Laboratory
URINEHPLC-ESI-MS/MS
2.023Day 1802021-12-15T08:002021-12-16T08:008
11TOB777002
9
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180OHCOT or HCTTTrans-3-hydroxycotinine (ng/mL)TOBACCO ALKALOID2000
Y2021-01-202021-12-202000ng/mLTobacco Marker Testing Laboratory33916-8URINE

0.13Day 1802021-12-15T08:002021-12-16T08:009
12TOB777002
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180
10
OHCOTG or 3HC-GlucTrans-3-hydroxycotinine glucuronide (ng/mL)TOBACCO ALKALOID3529
Y2021-01-202021-12-203529ng/mLTobacco Marker Testing Laboratory
URINE
0.03


103Day 1802021-12-15T08:002021-12-16T08:0010
13TOB777002
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180
11
NORNCTN or NNICNornicotine (ng/mL)TOBACCO ALKALOID6
Y2021-01-202021-12-206ng/mLTobacco Marker Testing Laboratory33917-6URINELC/MS/MS
2.503Day 1802021-12-15T08:002021-12-16T08:0011
14TOB777002
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180
12
ANBSAnabasine (ng/mL)TOBACCO ALKALOID5
Y2021-01-202021-12-205ng/mLTobacco Marker Testing Laboratory33915-0URINELC/MS/MS
0.513Day 1802021-12-15T08:002021-12-16T08:0012
15TOB777002
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180
13
NCOTNorcotinine (ng/mL)TOBACCO ALKALOID2
Y2021-01-202021-12-202ng/mLTobacco Marker Testing Laboratory77740-9URINE

1.113Day 1802021-12-15T08:002021-12-16T08:0013
16TOB777002
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 180180
14
ANTBAnatabine (ng/mL)TOBACCO ALKALOID9.1
Y2021-01-202021-12-209.1ng/mLTobacco Marker Testing Laboratory
URINEHPLC-ESI-MS/MS

3Day 1802021-12-15T08:002021-12-16T08:0014
17TOB7772001
Product A15DEC202115DEC2021:08:0016DEC2021:08:00Day 6060
1

OH_2_FLU or 2-FLU

2-Hydroxyfluorene 3‐Hydroxyfluorene (3‐FLU) (ng/mL)POLYNUCLEAR AROMATIC HYDROCARBON30
Y2021-07-152022-06-3030ng/mLTobacco Marker Testing Laboratory3853-9URINELC-MS/MS
3853-9


2Day 602021-09-
15T010
15T10:002021-09-
16T009
16T09:201
18TOB7772001
Product A15AUG202115AUG2021:10:0016AUG2021:10:00Day 6060
2
OH1NAPHT1-Hydroxynaphthalene (ng/mL)POLYNUCLEAR AROMATIC HYDROCARBON400
Y2021-07-152022-06-30400ng/mLTobacco Marker Testing Laboratory10365-5URINELC-MS/MS
10365-5


2Day 602021-09-
15T010
15T10:002021-09-
16T009
16T09:202
19TOB7772001
3
Product A15AUG202115AUG2021:10:0016AUG2021:10:00Day 6060OH1PHE

1-Hydroxyphenanthrene (ng/mL)

POLYNUCLEAR AROMATIC HYDROCARBON45
Y2021-07-152022-06-3045ng/mLTobacco Marker Testing Laboratory3854-7URINELC-MS/MS
3854-7


2Day 602021-09-
15T010
15T10:002021-09-
16T009
16T09:203
20TOB7772001
4
Product A15AUG202115AUG2021:10:0016AUG2021:10:00Day 6060OH3BAP3-Hydroxybenzo[a]pyrene (ng/mL)POLYNUCLEAR AROMATIC HYDROCARBON300
Y2021-07-152022-06-30300ng/mLTobacco Marker Testing Laboratory10366-3URINELC-MS/MS
10366-3


2Day 602021-09-
15T010
15T10:002021-09-
16T009
16T09:204
21TOB7772001
Product A15AUG2021

Day 6060
5
COCarbon Monoxide (%)VARIOUS GASES10
Y

10%Tobacco Marker Testing Laboratory
EXPIRED AIRMultiple Wavelength Spectrophotometer

2Day 602021-09-15
5



Definexmltable
LevelDataset
PurposeAnalysis
NameADLB
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADLBLaboratory Analysis DatasetBASIC DATA STRUCTUREOne or more records per subject per analysis parameter per analysis visit per analysis timepointAnalysisSTUDYID, USUBJID, PARAM, PARAMCD, AVISIT,ADLB.xptADLB.SAS/SAP
Definexmltable
DatasetADLB
LevelVariable
PurposeAnalysis
NameADLB
Variable NameVariable LabelTypeCodelist/Controlled TermsCoreCDISC Notes

STUDYID

Study IdentifierChar
ReqLB.STUDYID
USUBJIDUnique Subject IdentifierChar
ReqLB.USUBJID
TRTPPlanned
Treatment
ProductChar
CondADSL.TRT01P
TRT01PPlanned Treatment for Period xxCharCondADSL.TRT01P
ADTAnalysis DateNum
PermLB.LBDTC captured as a date in numeric format
.
ADTM
Analysis Datetime

Num
PermLB.LBDTC captured as a
datetime
dateTIME in numeric format
.
ADY
AENDTM
Analysis Relative Day

Num


PermLB.
LBDY
LBENDTC captured as a datetime in numeric format.
AVISITAnalysis VisitChar
CondLB.VISIT
AVISITNAnalysis Visit (N)Num
PermLB.VISITNUM
PARAMParameterChar
ReqLB.LBTEST concatenated with LB.LBSTRESU
PARAMCDParameter Codetext
ReqLB.LBTESTCD
PARAMNParameter (N)NumPerm
PARCAT1Parameter Category 1Char
PermLB.LBCAT
AVALAnalysis ValueNum
CondLB.LBSTRESN
BASEBaseline Value
NumCondAVAL where
ABLFL
=Y
CHGChange from
Baseline
NumPermAVAL-BASEABLFLBaseline
Record FlagCharYCondset to Y for last pre-
treatment
Product assessment  fir each parameter
COUNTRY
SAFFL
Country
Safety Population FlagCharY;N
Perm
CondADSL.
COUNTRY
SAFFL
AGEAge
TRTSDTDate of First Exposure to productNum
PermADSL.
AGE
TRTSDT
SEXSex
TRTEDTDate of Last Exposure to ProductNum
Char

PermADSL.
SEXRACERace
TRTEDT
LBSTRESNNumeric
Result/Finding
in Standard
Units

PermLB.LBSTRESN
LBSTRESUStandard Units
Char


Perm
ADSL
LB.
RACE
LBSTRESU
ETHNIC
LBNAM
Ethnicity
Vendor NameChar
Perm
ADSL
LB.
ETHNIC
LBNAM
SAFFLSafety Population Flag
LBLOINCLOINC CodeChar
Y;NCondADSL.SAFFLRANDFLRandomized Population Flag

PermLB.LBLOINC
LBSPECSpecimen TypeChar
Y;NCondADSL.RANDFL

PermLB.LBSPEC
LBMETHODMethod of Test or ExaminationChar
PermLB.LBMETHOD
LBLOBXFLLast Observation Before Exposure FlagChar
PermLB.LBLOBXFL
LBLLOQLower Limit of Quantitation
TRTSDTDate of First Exposure to TreatmentNumPermADSL.TRTSDTTRTEDTDate of Last Exposure to TreatmentNumPermADSL.TRTEDTLBSEQSequence Number
Num
PermLB.
LBSEQ
LBLLOQ
VISITVisit NameChar
PermLB.LB.VISIT
VISITNUMVisit NumberNum
PermLB.VISITNUM
LBDTCDate/Time of Specimen CollectionChar
PermLB.LBDTC
LBENDTCEnd Date/Time of Specimen CollectionChar
PermLB.LBENDTC
LBSEQSequence NumberNum
PermLB.LBSEQ