SDTM Example.Product HPHC Cigarette Testing

Tobacco product HPHC testing results are represented in the PT domain. This example assumes testing at a single time point, not serial testing over multiple timepoints as in stability studies. See the Stability Studies section for more information and examples on handling those data.

This example only shows test results for each constituent for one replicate of one sample of one product that was tested (PTREPNUM = 1 for all records). Details of the sampling and testing plan, including the number of samples of the products tested, are determined by the sponsor or by regulatory requirement. Sponsors would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset by values of PTREPNUM being set to 1 through n, where n = the number of replicates being performed.

Rows 1-17:	Show HPHC testing performed in smoke produced by a smoking machine from the tobacco product identified in SPTOBID (CIG01a). Note of the use of SPDEVID as the device identifier for the smoking machine and the use of PTREFID to identify the smoking regimen ( Non-intense regimen). PTSPEC=SMOKE to indicate the specimen type is smoke.
Row 18:	Shows one analyte was tested with a different smoking regimen ( intense regimen) using the same smoking machine.
Row 19:	Shows one analyte was tested in the tobacco filler (PTSPEC). Thus SPDEVID and PTREFID are null.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	SPDEVID	PTSEQ	PTREFID	PTCAS	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTXFN	PTNAM	PTSPEC	PTREPNUM	PTDTC
1	TOB07	PT	CIG01a	PUFFMASTER3K	1	NON-INTENSE REGIMEN	75-07-0	ACTALD	Acetaldehyde	HPHC TESTING	HPHC	522	ug/cigarette	522	522	ug/cigarette	TL001_V5.pdf	TPT LABCO	SMOKE	1	2022-09-30
2	TOB07	PT	CIG01a	PUFFMASTER3K	2	NON-INTENSE REGIMEN	107-02-8	ACROLEIN	Acrolein	HPHC TESTING	HPHC	43	ug/cigarette	43	43	ug/cigarette	TL002_V3.6.pdf	TPT LABCO	SMOKE	1	2022-09-30
3	TOB07	PT	CIG01a	PUFFMASTER3K	3	NON-INTENSE REGIMEN	107-13-1	ACRYNTRL	Acrylonitrile	HPHC TESTING	HPHC	7	ug/cigarette	7	7	ug/cigarette	TL006_V6.pdf	TPT LABCO	SMOKE	1	2022-09-30
4	TOB07	PT	CIG01a	PUFFMASTER3K	4	NON-INTENSE REGIMEN	92-67-1	ABP4	4-Aminobiphenyl	HPHC TESTING	HPHC	1.2	ng/cigarette	1.2	1.2	ng/cigarette	TL008_V3.pdf	TPT LABCO	SMOKE	1	2022-09-30
5	TOB07	PT	CIG01a	PUFFMASTER3K	5	NON-INTENSE REGIMEN	134-32-7	AMNPHTH1	1-Aminonaphthalene	HPHC TESTING	HPHC	14	ng/cigarette	14	14	ng/cigarette	TL003_V1.4.pdf	TPT LABCO	SMOKE	1	2022-09-30
6	TOB07	PT	CIG01a	PUFFMASTER3K	6	NON-INTENSE REGIMEN	134-32-7	AMNPHTH2	2-Aminonaphthalene	HPHC TESTING	HPHC	8	ng/cigarette	8	8	ng/cigarette	TL003_V1.4.pdf	TPT LABCO	SMOKE	1	2022-09-30
7	TOB07	PT	CIG01a	PUFFMASTER3K	7	NON-INTENSE REGIMEN	7664-41-7	AMMONIA	Ammonia	HPHC TESTING	HPHC	9	ug/cigarette	9	9	ug/cigarette	TL020_V4.pdf	TPT LABCO	SMOKE	1	2022-09-30
8	TOB07	PT	CIG01a	PUFFMASTER3K	8	NON-INTENSE REGIMEN	71-43-2	BENZENE	Benzene	HPHC TESTING	HPHC	33	ug/cigarette	33	33	ug/cigarette	TL017_V1.1.pdf	TPT LABCO	SMOKE	1	2022-09-30
9	TOB07	PT	CIG01a	PUFFMASTER3K	9	NON-INTENSE REGIMEN	50-32-8	BZAPYR	Benzo[a]pyrene	HPHC TESTING	HPHC	6.8	ng/cigarette	6.8	6.8	ng/cigarette	TL017_V1.1.pdf	TPT LABCO	SMOKE	1	2022-09-30
10	TOB07	PT	CIG01a	PUFFMASTER3K	10	NON-INTENSE REGIMEN	630-08-0	CMONOX	Carbon Monoxide	HPHC TESTING	HPHC	10.1	mg/cigarette	10.1	10.1	mg/cigarette	TL019_V3.pdf	TPT LABCO	SMOKE	1	2022-09-30
11	TOB07	PT	CIG01a	PUFFMASTER3K	11	NON-INTENSE REGIMEN	4170-30-3	CROTNALD	Crotonaldehyde	HPHC TESTING	HPHC	11	ug/cigarette	11	11	ug/cigarette	TL001_V5.pdf	TPT LABCO	SMOKE	1	2022-09-30
12	TOB07	PT	CIG01a	PUFFMASTER3K	12	NON-INTENSE REGIMEN	50-00-0	FORMALD	Formaldehyde	HPHC TESTING	HPHC	27	ug/cigarette	27	27	ug/cigarette	TL001_V5.pdf	TPT LABCO	SMOKE	1	2022-09-30
13	TOB07	PT	CIG01a	PUFFMASTER3K	13	NON-INTENSE REGIMEN	78-79-5	ISOPRENE	Isoprene	HPHC TESTING	HPHC	320	ug/cigarette	320	320	ug/cigarette	TL041_V1.pdf	TPT LABCO	SMOKE	1	2022-09-30
14	TOB07	PT	CIG01a	PUFFMASTER3K	14	NON-INTENSE REGIMEN	1954-11-05	NICOTINE	Nicotine	HPHC TESTING	HPHC	0.721	mg/cigarette	0.721	0.721	mg/cigarette	TL007_V2.1.pdf	TPT LABCO	SMOKE	1	2022-09-30
15	TOB07	PT	CIG01a	PUFFMASTER3K	15	NON-INTENSE REGIMEN	64091-91-4	NNK	Nicotine-Derived Nitrosamine Ketone	HPHC TESTING	HPHC	71	ng/cigarette	71	71	ng/cigarette	TL026_V12.2.pdf	TPT LABCO	SMOKE	1	2022-09-30
16	TOB07	PT	CIG01a	PUFFMASTER3K	16	NON-INTENSE REGIMEN	16543-55-8	NNN	N-Nitrosonornicotine	HPHC TESTING	HPHC	85	ng/cigarette	85	85	ng/cigarette	TL026_V12.2.pdf	TPT LABCO	SMOKE	1	2022-09-30
17	TOB07	PT	CIG01a	PUFFMASTER3K	17	NON-INTENSE REGIMEN	108-88-3	TOLUENE	Toluene	HPHC TESTING	HPHC	53	ug/cigarette	53	53	ug/cigarette	TL011_V3.3.pdf	TPT LABCO	SMOKE	1	2022-09-30
18	TOB07	PT	CIG01a	PUFFMASTER3K	18	INTENSE REGIMEN	75-07-0	ACTALD	Acetaldehyde	HPHC TESTING	HPHC	1552	ug/cigarette	1552	1552	ug/cigarette	TL009_V4.3.pdf	TPT LABCO	SMOKE	1	2022-09-30
19	TOB07	PT	CIG01a	PUFFMASTER3K	19		7664-41-7	AMMONIA	Ammonia	HPHC TESTING	HPHC	956	ug/g	956	956	ug/cigarette	TL016_V1.2.pdf	TPT LABCO	TOBACCO FILLER	1	2022-09-30

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset. DI is the source of the sponsor-defined device ID variable (SPDEVID) used in the PT dataset to indicate the smoking machine used to perform the smoking regimen.

di.xpt

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	TOB07	DI	PUFFMASTER3K	1	DEVTYPE	Device Type	Smoking Machine
2	TOB07	DI	PUFFMASTER3K	2	MANUF	Manufacturer	Acme
3	TOB07	DI	PUFFMASTER3K	3	TRADENAM	Trade Name	PuffMaster 3000

$warningHtml

Details of the smoking regimen performed by the smoking machine are represented as device in-use properties (such as settings) of the smoking machine. They are linked to the HPHC testing results in PT above by matching values of PTREFID/DUREFID.

Rows 1-9:	Show the parameters of the non-intense smoking regimen.
Rows 8-9:	Note the use of PTGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together they tell us that this smoking regimen pauses for 60 seconds every 10 puffs.
Rows 10-18:	Show the parameters of the intense smoking regimen.
Rows 17-18:	Note the use of PTGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together they tell us that this smoking regimen pauses for 30 seconds every 10 puffs.

du.xpt

Row	STUDYID	DOMAIN	SPDEVID	DUSEQ	DUREFID	DUGRPID	DUTESTCD	DUTEST	DUORRES	DUORRESU	DUSTRESC	DUSTRESN	DUSTRESU
1	TOB07	DU	PUFFMASTER3K	1	INTENSE METHOD		PUFFPROF	Puff Profile	SQUARE		SQUARE
2	TOB07	DU	PUFFMASTER3K	2	INTENSE METHOD		PUFFDUR	Puff Duration	1.25	sec	1.25	1.25	sec
3	TOB07	DU	PUFFMASTER3K	3	INTENSE METHOD		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
4	TOB07	DU	PUFFMASTER3K	4	INTENSE METHOD		PUFFBLCK	Puff Block	25	%	25	25	%
5	TOB07	DU	PUFFMASTER3K	5	INTENSE METHOD		NUMPUFF	Total Number of Puffs	200	PUFF	200	200	PUFF
6	TOB07	DU	PUFFMASTER3K	6	INTENSE METHOD		PUFFVOL	Puff Volume	10	mL	10	10	mL
7	TOB07	DU	PUFFMASTER3K	7	INTENSE METHOD		PUFFRNG	Puff Range	100-200		100-200
8	TOB07	DU	PUFFMASTER3K	8	INTENSE METHOD	1	PUFFPAUS	Puff Pause	60	s	60	60	s
9	TOB07	DU	PUFFMASTER3K	9	INTENSE METHOD	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF
10	TOB07	DU	PUFFMASTER3K	1	INTENSE METHOD		PUFFPROF	Puff Profile	SQUARE		SQUARE
11	TOB07	DU	PUFFMASTER3K	2	INTENSE METHOD		PUFFDUR	Puff Duration	1.5	sec	1.5	1.5	sec
12	TOB07	DU	PUFFMASTER3K	3	INTENSE METHOD		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
13	TOB07	DU	PUFFMASTER3K	4	INTENSE METHOD		PUFFBLCK	Puff Block	30	%	30	30	%
14	TOB07	DU	PUFFMASTER3K	5	INTENSE METHOD		NUMPUFF	Total Number of Puffs	100	PUFF	100	100	PUFF
15	TOB07	DU	PUFFMASTER3K	6	INTENSE METHOD		PUFFVOL	Puff Volume	10	mL	10	10	mL
16	TOB07	DU	PUFFMASTER3K	7	INTENSE METHOD		PUFFRNG	Puff Range	50-150		50-150
17	TOB07	DU	PUFFMASTER3K	8	INTENSE METHOD	2	PUFFPAUS	Puff Pause	30	s	30	30	s
18	TOB07	DU	PUFFMASTER3K	9	INTENSE METHOD	2	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Page tree

SDTM Example.Product HPHC Cigarette Testing