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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

Dataset wrap

Name	adlb

Dataset2

tableid	adlb

Row	STUDYID	USUBJID	TRTP	ADT	ADTM	AENDTM	AVISIT	AVISITN	PARAMCD	PARAM	PARCAT1	AVAL	ABLFL	SAFFL	TRTSDT	TRTEDT	LBSTRESN	LBSTRESU	LBNAM	LBLOINC	LBSPEC	LBMETHOD	LBLOBXFL	LBLLOQ	VISITNUM	VISIT	LBDTC	LBENDTC	LBSEQ
1	TOB777	001	Product A	17JAN2021			Baseline	0	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	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	Product A	21JUN2021	21JUN2021:08:00	22JUN2021:08:00	Baseline	0	CREAT	Creatinine (ng/mL)	24-HOUR URINE TEST	0.8	Y	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	VOLUME	Volume (mL)	24-HOUR URINE TEST	1875	Y	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	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	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	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	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	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	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	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	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			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	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	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	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	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	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			2	Day 60	2021-09-15T10:00	2021-09-16T09:20	1
18	TOB777	2001	Product A	15AUG2021	15AUG2021:10:00	16AUG2021:10:00	Day 60	60	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			2	Day 60	2021-09-15T10:00	2021-09-16T09:20	2
19	TOB777	2001	Product A	15AUG2021	15AUG2021:10:00	16AUG2021:10:00	Day 60	60	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			2	Day 60	2021-09-15T10:00	2021-09-16T09:20	3
20	TOB777	2001	Product A	15AUG2021	15AUG2021:10:00	16AUG2021:10:00	Day 60	60	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			2	Day 60	2021-09-15T10:00	2021-09-16T09:20	4
21	TOB777	2001	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	Codelist/Controlled Terms	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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