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Dataset wrap

Name	adlb

Dataset2

tableid	adlb

Row	STUDYID	USUBJID

LBSEQ

TRTP	ADT	ADTM	AENDTM	AVISIT	AVISITN	PARAMCD	PARAM	PARCAT1	AVAL

BASE

ABLFL	SAFFL

CHG

TRTSDT

ABLFL

TRTEDT	LBSTRESN	LBSTRESU	LBNAM	LBLOINC	LBSPEC	LBMETHOD	LBLOBXFL	LBLLOQ	VISITNUM	VISIT	LBDTC	LBENDTC	LBSEQ
1	TOB777	001

Product A

17JAN2021

Baseline

0

1

	NICOTINE	Nicotine (ng/mL)	TOBACCO ALKALOID	30	Y	Y	2021-01-20	2021-12-20	30	ng/mL	Tobacco Marker Testing Laboratory	3853-9	SERUM	LC/MS/MS	Y	2	1	BASELINE	2021-01-17		1
2	TOB777	001

2

Product A	20JUL2021			Day 180	180	COTININE	Cotinine (ng/mL)	TOBACCO ALKALOID	400		Y	2021-01-20	2021-12-20	400	ng/mL	Tobacco Marker Testing Laboratory	10365-5	SERUM	LC/MS/MS		2	3	Day 180	2021-07-20		2
3	TOB777	002

1

Product A

21JUN2021

21JUN2021:08:00

22JUN2021:08:00

Baseline

0

CREAT

Creatinine (ng/mL)

24-HOUR URINE TEST

0.8

Y

2021-01-20

2021-12-20

0.8

ng/mL

Tobacco Marker Testing Laboratory

65634-8

URINE

LC-MS-MS

Y

1

BASELINE

2021-06-21T08:00

2021-06-22T08:00

1

4

TOB777

002

Product A

21JUN2021

21JUN2021:08:00

22JUN2021:08:00

Baseline

0

2

VOLUME

Volume (mL)

24-HOUR URINE TEST

1875

Y

2021-01-20

2021-12-20

1875

mL

Tobacco Marker Testing Laboratory

URINE

Y

1

BASELINE

2021-06-21T08:00

2021-06-22T08:00

2

5

TOB777

002

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

3

	NICOTINE	Nicotine (ng/mL)	TOBACCO ALKALOID	45		Y	2021-01-20	2021-12-20	45	ng/mL	Tobacco Marker Testing Laboratory	3854-7	URINE	LC-MS/MS		0.2	3	Day 180	2021-12-15T08:00	2021-12-16T08:00	3
6	TOB777	002

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

4

	NICGLUC	Nicotine-glucuronide (ng/mL)	TOBACCO ALKALOID	40		Y	2021-01-20	2021-12-20	40	ng/mL	Tobacco Marker Testing Laboratory		URINE			0.2	3	Day 180	2021-12-15T08:00	2021-12-16T08:00	4
7	TOB777	002

5

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

NOXT

Nicotine-1 N-oxid (ng/mL)

TOBACCO ALKALOID

113.5

Y

2021-01-20

2021-12-20

113.5

ng/mL

Tobacco Marker Testing Laboratory

URINE

HPLC-ESI-MS/MS

2.50

3

Day 180

2021-12-15T08:00

2021-12-16T08:00

5

8

TOB777

002

6

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

COTININE

Cotinine (ng/mL)

TOBACCO ALKALOID

300

Y

2021-01-20

2021-12-20

300

ng/mL

Tobacco Marker Testing Laboratory

10366-3

URINE

LC/MS/MS)

0.05

3

Day 180

2021-12-15T08:00

2021-12-16T08:00

6

9

TOB777

002

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

7

	COTGLUC	Cotinine-glucuronide (ng/mL)	TOBACCO ALKALOID	275		Y	2021-01-20	2021-12-20	275	ng/mL	Tobacco Marker Testing Laboratory		URINE			0.2	3	Day 180	2021-12-15T08:00	2021-12-16T08:00	7
10	TOB777	002

8

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

COXT

Cotinine-n-oxide (ng/mL)

TOBACCO ALKALOID

117.5

Y

2021-01-20

2021-12-20

117.5

ng/mL

Tobacco Marker Testing Laboratory

URINE

HPLC-ESI-MS/MS

2.02

3

Day 180

2021-12-15T08:00

2021-12-16T08:00

8

11

TOB777

002

9

Product A	15DEC2021	15DEC2021:08:00	16DEC2021:08:00	Day 180	180	OHCOT or HCTT	Trans-3-hydroxycotinine (ng/mL)	TOBACCO ALKALOID	2000		Y	2021-01-20	2021-12-20	2000	ng/mL	Tobacco Marker Testing Laboratory	33916-8	URINE			0.1	3	Day 180	2021-12-15T08:00	2021-12-16T08:00	9
12	TOB777	002

10

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

OHCOTG or 3HC-Gluc

Trans-3-hydroxycotinine glucuronide (ng/mL)

TOBACCO ALKALOID

3529

Y

2021-01-20

2021-12-20

3529

ng/mL

Tobacco Marker Testing Laboratory

URINE

0.03

		10	3	Day 180	2021-12-15T08:00	2021-12-16T08:00	10
13	TOB777	002

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

11

	NORNCTN or NNIC	Nornicotine (ng/mL)	TOBACCO ALKALOID	6		Y	2021-01-20	2021-12-20	6	ng/mL	Tobacco Marker Testing Laboratory	33917-6	URINE	LC/MS/MS		2.50	3	Day 180	2021-12-15T08:00	2021-12-16T08:00	11
14	TOB777	002

12

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

ANBS

Anabasine (ng/mL)

TOBACCO ALKALOID

5

Y

2021-01-20

2021-12-20

5

ng/mL

Tobacco Marker Testing Laboratory

33915-0

URINE

LC/MS/MS

0.51

3

Day 180

2021-12-15T08:00

2021-12-16T08:00

12

15

TOB777

002

13

Product A	15DEC2021	15DEC2021:08:00	16DEC2021:08:00	Day 180	180	NCOT	Norcotinine (ng/mL)	TOBACCO ALKALOID	2		Y	2021-01-20	2021-12-20	2	ng/mL	Tobacco Marker Testing Laboratory	77740-9	URINE			1.11	3	Day 180	2021-12-15T08:00	2021-12-16T08:00	13
16	TOB777	002

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 180

180

14

	ANTB	Anatabine (ng/mL)	TOBACCO ALKALOID	9.1		Y	2021-01-20	2021-12-20	9.1	ng/mL	Tobacco Marker Testing Laboratory		URINE	HPLC-ESI-MS/MS			3	Day 180	2021-12-15T08:00	2021-12-16T08:00	14
17	TOB777	2001

Product A

15DEC2021

15DEC2021:08:00

16DEC2021:08:00

Day 60

60

1

OH_2_FLU or 2-FLU

2-Hydroxyfluorene 3‐Hydroxyfluorene (3‐FLU) (ng/mL)

POLYNUCLEAR AROMATIC HYDROCARBON

30

Y

2021-07-15

2022-06-30

30

ng/mL

Tobacco Marker Testing Laboratory

3853-9

URINE

LC-MS/MS

3853-9

2

Day 60

2021-09-

15T010

15T10:00

2021-09-

16T009

16T09:20	1
18	TOB777	2001

Product A

15AUG2021

15AUG2021:10:00

16AUG2021:10:00

Day 60

60

2

OH1NAPHT

1-Hydroxynaphthalene (ng/mL)

POLYNUCLEAR AROMATIC HYDROCARBON

400

Y

2021-07-15

2022-06-30

400

ng/mL

Tobacco Marker Testing Laboratory

10365-5

URINE

LC-MS/MS

10365-5

2

Day 60

2021-09-

15T010

15T10:00

2021-09-

16T009

16T09:20	2
19	TOB777	2001

Product A

15AUG2021

15AUG2021:10:00

16AUG2021:10:00

Day 60

60

3

OH1PHE

1-Hydroxyphenanthrene (ng/mL)

POLYNUCLEAR AROMATIC HYDROCARBON

45

Y

2021-07-15

2022-06-30

45

ng/mL

Tobacco Marker Testing Laboratory

3854-7

URINE

LC-MS/MS

3854-7

2

Day 60

2021-09-

15T010

15T10:00

2021-09-

16T009

16T09:20	3
20	TOB777	2001

Product A

15AUG2021

15AUG2021:10:00

16AUG2021:10:00

Day 60

60

4

OH3BAP

3-Hydroxybenzo[a]pyrene (ng/mL)

POLYNUCLEAR AROMATIC HYDROCARBON

300

Y

2021-07-15

2022-06-30

300

ng/mL

Tobacco Marker Testing Laboratory

10366-3

URINE

LC-MS/MS

10366-3

2

Day 60

2021-09-

15T010

15T10:00

2021-09-

16T009

16T09:20	4
21	TOB777	2001

5

Product A

15AUG2021

Day 60

60

CO

Carbon Monoxide (%)

VARIOUS GASES

10

Y

10

%

Tobacco Marker Testing Laboratory

EXPIRED AIR

Multiple Wavelength Spectrophotometer

2

Day 60

2021-09-15

5

Definexmltable

Level	Dataset
Purpose	Analysis
Name	ADLB

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADLB	Laboratory Analysis Dataset	BASIC DATA STRUCTURE	One or more records per subject per analysis parameter per analysis visit per analysis timepoint	Analysis	STUDYID, USUBJID, PARAM, PARAMCD, AVISIT,	ADLB.xpt	ADLB.SAS/SAP

Definexmltable

Dataset	ADLB
Level	Variable
Purpose	Analysis
Name	ADLB

Variable Name	Variable Label	Type	Core	CDISC Notes
STUDYID	Study Identifier	Char	Req	LB.STUDYID
USUBJID	Unique Subject Identifier	Char	Req	LB.USUBJID
TRTP	Planned

...

Product	Char		Cond	ADSL.TRT01P
ADT	Analysis Date	Num		Perm	LB.LBDTC captured as a date in numeric format

...

ADTM

...

Num

Perm

LB.LBDTC captured as a

...

dateTIME in numeric format

...

AENDTM

Num

Perm

LB.

...

LBENDTC captured as a datetime in numeric format.
AVISIT	Analysis Visit	Char	Cond	LB.VISIT
AVISITN	Analysis Visit (N)	Num	Perm	LB.VISITNUM
PARAM	Parameter	Char	Req	LB.LBTEST concatenated with LB.LBSTRESU
PARAMCD	Parameter Code	text	Req	LB.LBTESTCD

...

PARCAT1	Parameter Category 1	Char		Perm	LB.LBCAT
AVAL	Analysis Value	Num		Cond	LB.LBSTRESN

...

ABLFL

...

Baseline

...

Record Flag

Char

Y

Cond

set to Y for last pre-

...

Product assessment fir each parameter

...

SAFFL

...

Safety Population Flag

Char

...

Y;N

Cond

ADSL.

...

SAFFL

...

TRTSDT

Date of First Exposure to product

Num

Perm

ADSL.

...

TRTSDT

...

TRTEDT

Date of Last Exposure to Product

Num

...

Perm

ADSL.

...

TRTEDT
LBSTRESN	Numeric Result/Finding in Standard Units	Perm	LB.LBSTRESN
LBSTRESU	Standard Units

...

Perm

...

LB.

...

LBSTRESU

...

LBNAM

...

Vendor Name

Char

Perm

...

LB.

...

LBNAM

...

LBLOINC

LOINC Code

...

Char

...

	Perm	LB.LBLOINC
LBSPEC	Specimen Type

...

Char

...

	Perm	LB.LBSPEC
LBMETHOD	Method of Test or Examination	Char	Perm	LB.LBMETHOD
LBLOBXFL	Last Observation Before Exposure Flag	Char	Perm	LB.LBLOBXFL
LBLLOQ	Lower Limit of Quantitation

...

Num

Perm

LB.

...

LBLLOQ
VISIT	Visit Name	Char	Perm	LB.LB.VISIT
VISITNUM	Visit Number	Num	Perm	LB.VISITNUM
LBDTC	Date/Time of Specimen Collection	Char	Perm	LB.LBDTC
LBENDTC	End Date/Time of Specimen Collection	Char	Perm	LB.LBENDTC
LBSEQ	Sequence Number	Num	Perm	LB.LBSEQ

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