ADaM Example.ADLB Subject HPHC Testing

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adlb.xpt

Row	STUDYID	USUBJID	LBSEQ	PARAMCD	PARAM	PARCAT1	AVAL	LBSTRESN	LBSTRESU	LBNAM	LBLOINC	LBSPEC	LBMETHOD	LBLOBXFL	LBLLOQ	VISITNUM	VISIT	LBDTC	LBENDTC
1	TOB777	001	1	NICOTINE	Nicotine (ng/mL)	TOBACCO ALKALOID	30	30	ng/mL	Tobacco Marker Testing Laboratory	3853-9	SERUM	LC/MS/MS	Y	2	1	BASELINE	2021-01-17
2	TOB777	001	2	COTININE	Cotinine (ng/mL)	TOBACCO ALKALOID	400	400	ng/mL	Tobacco Marker Testing Laboratory	10365-5	SERUM	LC/MS/MS		2	3	Day 180	2021-07-20
3	TOB777	002	1	CREAT	Creatinine (ng/mL)	24-HOUR URINE TEST	0.8	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
4	TOB777	002	2	VOLUME	Volume (mL)	24-HOUR URINE TEST	1875	1875	mL	Tobacco Marker Testing Laboratory		URINE		Y		1	BASELINE	2021-06-21T08:00	2021-06-22T08:00
5	TOB777	002	3	NICOTINE	Nicotine (ng/mL)	TOBACCO ALKALOID	45	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
6	TOB777	002	4	NICGLUC	Nicotine-glucuronide (ng/mL)	TOBACCO ALKALOID	40	40	ng/mL	Tobacco Marker Testing Laboratory		URINE			0.2	3	Day 180	2021-12-15T08:00	2021-12-16T08:00
7	TOB777	002	5	NOXT	Nicotine-1 N-oxid (ng/mL)	TOBACCO ALKALOID	113.5	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
8	TOB777	002	6	COTININE	Cotinine (ng/mL)	TOBACCO ALKALOID	300	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
9	TOB777	002	7	COTGLUC	Cotinine-glucuronide (ng/mL)	TOBACCO ALKALOID	275	275	ng/mL	Tobacco Marker Testing Laboratory		URINE			0.2	3	Day 180	2021-12-15T08:00	2021-12-16T08:00
10	TOB777	002	8	COXT	Cotinine-n-oxide (ng/mL)	TOBACCO ALKALOID	117.5	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
11	TOB777	002	9	OHCOT or HCTT	Trans-3-hydroxycotinine (ng/mL)	TOBACCO ALKALOID	2000	2000	ng/mL	Tobacco Marker Testing Laboratory	33916-8	URINE			0.1	3	Day 180	2021-12-15T08:00	2021-12-16T08:00
12	TOB777	002	10	OHCOTG or 3HC-Gluc	Trans-3-hydroxycotinine glucuronide (ng/mL)	TOBACCO ALKALOID	3529	3529	ng/mL	Tobacco Marker Testing Laboratory		URINE			0.03	3	Day 180	2021-12-15T08:00	2021-12-16T08:00
13	TOB777	002	11	NORNCTN or NNIC	Nornicotine (ng/mL)	TOBACCO ALKALOID	6	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
14	TOB777	002	12	ANBS	Anabasine (ng/mL)	TOBACCO ALKALOID	5	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
15	TOB777	002	13	NCOT	Norcotinine (ng/mL)	TOBACCO ALKALOID	2	2	ng/mL	Tobacco Marker Testing Laboratory	77740-9	URINE			1.11	3	Day 180	2021-12-15T08:00	2021-12-16T08:00
16	TOB777	002	14	ANTB	Anatabine (ng/mL)	TOBACCO ALKALOID	9.1	9.1	ng/mL	Tobacco Marker Testing Laboratory		URINE	HPLC-ESI-MS/MS			3	Day 180	2021-12-15T08:00	2021-12-16T08:00
17	TOB777	2001	1	OH_2_FLU or 2-FLU	2-Hydroxyfluorene 3‐Hydroxyfluorene (3‐FLU) (ng/mL)	POLYNUCLEAR AROMATIC HYDROCARBON	30	30	ng/mL	Tobacco Marker Testing Laboratory	3853-9	URINE	LC-MS/MS	3853-9		2	Day 60	2021-09-15T010:00	2021-09-16T009:20
18	TOB777	2001	2	OH1NAPHT	1-Hydroxynaphthalene (ng/mL)	POLYNUCLEAR AROMATIC HYDROCARBON	400	400	ng/mL	Tobacco Marker Testing Laboratory	10365-5	URINE	LC-MS/MS	10365-5		2	Day 60	2021-09-15T010:00	2021-09-16T009:20
19	TOB777	2001	3	OH1PHE	1-Hydroxyphenanthrene (ng/mL)	POLYNUCLEAR AROMATIC HYDROCARBON	45	45	ng/mL	Tobacco Marker Testing Laboratory	3854-7	URINE	LC-MS/MS	3854-7		2	Day 60	2021-09-15T010:00	2021-09-16T009:20
20	TOB777	2001	4	OH3BAP	3-Hydroxybenzo[a]pyrene (ng/mL)	POLYNUCLEAR AROMATIC HYDROCARBON	300	300	ng/mL	Tobacco Marker Testing Laboratory	10366-3	URINE	LC-MS/MS	10366-3		2	Day 60	2021-09-15T010:00	2021-09-16T009:20
21	TOB777	2001	5	CO	Carbon Monoxide (%)	VARIOUS GASES	10	10	%	Tobacco Marker Testing Laboratory		EXPIRED AIR	Multiple Wavelength Spectrophotometer			2	Day 60	2021-09-15

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ADXX Variable Metadata

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 Treatment	Char		Cond	ADSL.TRT01P
TRT01P	Planned Treatment for Period xx	Char		Cond	ADSL.TRT01P
ADT	Analysis Date	Num		Perm	LB.LBDTC captured as a date in numeric format.
ADTM	Analysis Datetime	Num		Perm	LB.LBDTC captured as a datetime in numeric format.
ADY	Analysis Relative Day	Num		Perm	LB.LBDY
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
PARAMN	Parameter (N)	Num		Perm
PARCAT1	Parameter Category 1	Char		Perm	LB.LBCAT
AVAL	Analysis Value	Num		Cond	LB.LBSTRESN
BASE	Baseline Value	Num		Cond	AVAL where ABLFL=Y
CHG	Change from Baseline	Num		Perm	AVAL-BASE
ABLFL	Baseline Record Flag	Char	Y	Cond	set to Y for last pre-treatment assessment fir each parameter
COUNTRY	Country	Char		Perm	ADSL.COUNTRY
AGE	Age	Num		Perm	ADSL.AGE
SEX	Sex	Char		Perm	ADSL.SEX
RACE	Race	Char		Perm	ADSL.RACE
ETHNIC	Ethnicity	Char		Perm	ADSL.ETHNIC
SAFFL	Safety Population Flag	Char	Y;N	Cond	ADSL.SAFFL
RANDFL	Randomized Population Flag	Char	Y;N	Cond	ADSL.RANDFL
TRTSDT	Date of First Exposure to Treatment	Num		Perm	ADSL.TRTSDT
TRTEDT	Date of Last Exposure to Treatment	Num		Perm	ADSL.TRTEDT
LBSEQ	Sequence Number	Num		Perm	LB.LBSEQ
VISIT	Visit Name	Char		Perm	LB.VISIT
VISITNUM	Visit Number	Num		Perm	LB.VISITNUM

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ADaM Example.ADLB Subject HPHC Testing