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The first dataset shows 22 constituents each as a single replicate, at one time point and from one set of storage conditions in order to illustrate the variables and terminology required to construct an SDTM-conformant PT dataset for a stability study. Some constituent names (Values of PTTESTCD/PTTEST) appear multiple times because they are tested separately in e-liquid and aerosol (as indicated by PTSPEC). Note that the constituent names shown do not represent an exhaustive list of the controlled terminology that will be developed to support representation of stability studies in SDTM.

Note

The use of SPDEVID and PTREFID in this example on records where PTSPEC=AEROSOL indicates that a smoking machine (SPDEVID) was used to perform a smoking regimen (PTREFID) to produce the aerosol from the e-liquid product. Smoking machine and smoking regimen data are not shown. For an example illustrating these concepts, see Section 3.1.3.1, Harmful and Potentially Harmful Constituents (HPHCs) and Smoking Regimens.

Dataset wrap

Name	pt

Rowcaps

Rows 1-31:	Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in STOCONDID which is Condition 1.
Rows 2, 4, 6, 8, 11, 12, 13, 14, 16, 20, 21, 23, 26:	Show the several analytes such as Nicotine, 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK), and N-nitrosonornicotine analytes in the Aerosol substance represented using the PTSPEC variable.
Rows 28, 29:	Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTSCAT variable.

Dataset2

Row	STUDYID	DOMAIN	SPDEVID	SPTOBID	STOCONDID	PTSEQ	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTORRES	PTORRESU	PTLLOD	PTSTRESC	PTSTRESN	PTSTRESU	PTNAM	PTXFN	PTSPEC	PTLLOQ	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT		111	Condition 1	1	NICOTINE	Nicotine	STABILITY STUDY		35.94	mg/g		35.94	35.94	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
2	TOB07	PT	PUFFMASTER3K	111	Condition 1	2	NICOTINE	Nicotine	STABILITY STUDY		0.1039	mg/PUFF		0.1039	0.1039	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
3	TOB07	PT		111	Condition 1	3	NORNCTN	Nornicotine	STABILITY STUDY	Nicotine Degradant	25.76	ug/g		25.76	25.76	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
4	TOB07	PT	PUFFMASTER3K	111	Condition 1	4	NORNCTN	Nornicotine	STABILITY STUDY	Nicotine Degradant	0.0392	ug/PUFF		0.0392	0.0392	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
5	TOB07	PT		111	Condition 1	5	GLYCRL	Glycerol	STABILITY STUDY	Primary Ingredient	615.68	mg/g		615.68	615.68	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
6	TOB07	PT	PUFFMASTER3K	111	Condition 1	6	GLYCRL	Glycerol	STABILITY STUDY	Primary Ingredient	1.81	mg/PUFF	0.00144	1.81	1.81	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
7	TOB07	PT		111	Condition 1	7	PRPYLGLY	Propylene Glycol	STABILITY STUDY	Primary Ingredient	218.21	mg/g		218.21	218.21	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
8	TOB07	PT	PUFFMASTER3K	111	Condition 1	8	PRPYLGLY	Propylene Glycol	STABILITY STUDY	Primary Ingredient	0.8565	mg/PUFF	0.00024	0.8565	0.8565	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
9	TOB07	PT		111	Condition 1	9	BNZOICAC	Benzoic Acid	STABILITY STUDY	Acid	42.2	ug/PUFF		42.2	42.2	ug/PUFF	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
10	TOB07	PT		111	Condition 1	10	MENTHOL	Menthol	STABILITY STUDY	Flavorant	37.53	mg/g		37.53	37.53	mg/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
11	TOB07	PT	PUFFMASTER3K	111	Condition 1	11	MENTHOL	Menthol	STABILITY STUDY	Flavorant	0.5881	mg/PUFF	0.00024	0.5881	0.5881	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
12	TOB07	PT	PUFFMASTER3K	111	Condition 1	12	GLYCDOL	Glycidol	STABILITY STUDY	Stabilizer	NOT DETECTED		0.00011	NOT DETECTED			TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
13	TOB07	PT	PUFFMASTER3K	111	Condition 1	13	FRMLDHD	Formaldehyde	STABILITY STUDY		0.0728	ug/PUFF	0.00549	0.0728	0.0728	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
14	TOB07	PT	PUFFMASTER3K	111	Condition 1	14	ACROLN	Acrolien	STABILITY STUDY		DETECTED, BELOW LLOQ		0.00928	DETECTED, BELOW LLOQ			TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
15	TOB07	PT		111	Condition 1	15	LACTICAC	Lactic Acid	STABILITY STUDY		40.44	ug/g		40.44	40.44	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
16	TOB07	PT	PUFFMASTER3K	111	Condition 1	16	LACTICAC	Lactic Acid	STABILITY STUDY		29.71	ug/PUFF	0.284	29.71	29.71	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
17	TOB07	PT		111	Condition 1	17	VANLLN	Vanillin	STABILITY STUDY	Flavorant	1.12	ug/g		1.12	1.12	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
18	TOB07	PT		111	Condition 1	18	NNK	Nicotine-Derived Nitrosamine Ketone	STABILITY STUDY	HPHC	0.0711	ug/g		0.0711	0.0711	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
19	TOB07	PT		111	Condition 1	19	NNN	N-Nitrosonornicotine	STABILITY STUDY	HPHC	0.0852	ug/g		0.0852	0.0852	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
20	TOB07	PT	PUFFMASTER3K	111	Condition 1	20	NNK	Nicotine-Derived Nitrosamine Ketone	STABILITY STUDY	HPHC	0.0577	ug/PUFF		0.0577	0.0577	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
21	TOB07	PT	PUFFMASTER3K	111	Condition 1	21	NNN	N-Nitrosonornicotine	STABILITY STUDY	HPHC	0.0742	ug/PUFF		0.0742	0.0742	ug/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
22	TOB07	PT		111	Condition 1	22	NICKEL	Nickel	STABILITY STUDY	Extractables / Leachables	0.0897	ug/g		0.0897	0.0897	ug/g	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
23	TOB07	PT	PUFFMASTER3K	111	Condition 1	23	MASS	Mass	STABILITY STUDY		3.87	mg/PUFF	0.0071	3.87	3.87	mg/PUFF	TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
24	TOB07	PT		111	Condition 1	24	CHROMIUM	Chromium	STABILITY STUDY		NOT DETECTED			NOT DETECTED			TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
25	TOB07	PT		111	Condition 1	25	PH	pH	STABILITY STUDY		7.15			7.15	7.15		TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
26	TOB07	PT	PUFFMASTER3K	111	Condition 1	26	PH	pH	STABILITY STUDY		7.24			7.24	7.24		TPT LABCO	TLAE01_v2.1.pdf	AEROSOL	0.001	1	Week 0	1
27	TOB07	PT		111	Condition 1	27	ENDTXN	Endotoxin	STABILITY STUDY	Toxins	NOT DETECTED			NOT DETECTED			TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
28	TOB07	PT		111	Condition 1	28	AEBPLCT	Aerobic Plate Count	STABILITY STUDY	Microbiological	<1	CFU/mL		<1		CFU/mL	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
29	TOB07	PT		111	Condition 1	29	TYMC	Total Yeast and/or Mold Count	STABILITY STUDY	Microbiological	1	CFU/mL		1	1	CFU/mL	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
30	TOB07	PT		111	Condition 1	30	ACTALD	Acetaldehyde	STABILITY STUDY	Aldehyde	7.8	ug/mL		7.8	7.8	ug/mL	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1
31	TOB07	PT		111	Condition 1	31	ACTPROPN	Acetyl Propionyl	STABILITY STUDY	Diketone	32.4	ug/mL		32.4	32.4	ug/mL	TPT LABCO	TLEL01_v1.5.pdf	E-LIQUID	0.001	1	Week 0	1

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