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The first pt.xpt dataset shows 7 constituents / parameters, each as a single replicate (PTREPNUM=1), at one time point (PTTPT=Week 0 / PTTPTNUM=1) and from one set of storage conditions (STOCONID= Condition 1) in order to illustrate the variables and terminology required to construct an SDTM-conformant PT dataset for a stability study of a smokeless product. Some constituent names (Values of PTTESTCD/PTTEST) appear twice because they are tested separately in both tobacco "as-is" and dried tobacco (as indicated by PTSPEC / PTSPECCNDand PTSPCCND). 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.

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The second pt.xpt dataset shows testing for just one constituent, nicotineproduct moisture, performed in three replicates (note the values of PTREPNUM), at three time points (as shown in PTTPT / PTTPTNUM), from three two sets of storage conditions (STOCONID), in samples of e-liquid and aerosol )PTSPECboth dried and as-is tobacco (PTSPEC, PTSPCCND) in order to illustrate how those variables are used to represent their associated concepts in a stability study.

As in the first pt.xpt dataset, the details of the smoking machine and smoking regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.1, Harmful and Potentially Harmful Constituents (HPHCs) and Smoking Regimens.

Note

Details of the three storage conditions are represented in the ES dataset example that follows below.

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Dataset wrap

Name	pt

Rowcaps

Rows 1-9:	Show the results of testing Product Moisture in three replicates (PTREPNUM) at three timepoints (Week 0, Week 8, and Week 24) under the storage "Condition 1", indicated in STOCONID.
Rows 10-18::	Show the results of testing Product Moisture in three replicates (PTREPNUM) at three timepoints (Week 0, Week 8, and Week 24) under the storage "Condition 2", indicated in STOCONID.

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	STOCONID	PTSEQ	PTTESTCD	PTTEST	PTORRES	PTORRESU	PTLLOD	PTSTRESC	PTSTRESN	PTSTRESU	PTXFN	PTNAM	PTSPEC	PTSPCCND	PTLLOQ	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT	Smokeless01	Condition 1	111	PRODMST	Product Moisture	51.93	%	0.1	51.93	51.93	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	Week 0	1
2	TOB07	PT	Smokeless01	Condition 1	112	PRODMST	Product Moisture	51.96	%	0.1	51.96	51.96	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	Week 0	1
3	TOB07	PT	Smokeless01	Condition 1	113	PRODMST	Product Moisture	51.98	%	0.1	51.98	51.98	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	Week 0	1
4	TOB07	PT	Smokeless01	Condition 1	114	PRODMST	Product Moisture	51.75	%	0.1	51.75	51.75	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	Week 8	2
5	TOB07	PT	Smokeless01	Condition 1	115	PRODMST	Product Moisture	51.75	%	0.1	51.75	51.75	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	Week 8	2
6	TOB07	PT	Smokeless01	Condition 1	116	PRODMST	Product Moisture	51.67	%	0.1	51.67	51.67	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	Week 8	2
7	TOB07	PT	Smokeless01	Condition 1	117	PRODMST	Product Moisture	52.05	%	0.1	52.05	52.05	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	Week 24	3
8	TOB07	PT	Smokeless01	Condition 1	118	PRODMST	Product Moisture	52.68	%	0.1	52.68	52.68	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	Week 24	3
9	TOB07	PT	Smokeless01	Condition 1	119	PRODMST	Product Moisture	52.21	%	0.1	52.21	52.21	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	Week 24	3
10	TOB07	PT	Smokeless01	Condition 2	120	PRODMST	Product Moisture	51.93	%	0.1	51.93	51.93	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	Week 0	1
11	TOB07	PT	Smokeless01	Condition 2	121	PRODMST	Product Moisture	51.96	%	0.1	51.96	51.96	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	Week 0	1
12	TOB07	PT	Smokeless01	Condition 2	122	PRODMST	Product Moisture	51.98	%	0.1	51.98	51.98	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	Week 0	1
13	TOB07	PT	Smokeless01	Condition 2	123	PRODMST	Product Moisture	51.80	%	0.1	51.80	51.80	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	Week 8	2
14	TOB07	PT	Smokeless01	Condition 2	124	PRODMST	Product Moisture	51.77	%	0.1	51.77	51.77	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	Week 8	2
15	TOB07	PT	Smokeless01	Condition 2	125	PRODMST	Product Moisture	51.84	%	0.1	51.84	51.84	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	Week 8	2
16	TOB07	PT	Smokeless01	Condition 2	126	PRODMST	Product Moisture	52.18	%	0.1	52.18	52.18	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	1	Week 24	3
17	TOB07	PT	Smokeless01	Condition 2	127	PRODMST	Product Moisture	52.21	%	0.1	52.21	52.21	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	2	Week 24	3
18	TOB07	PT	Smokeless01	Condition 2	128	PRODMST	Product Moisture	51.87	%	0.1	51.87	51.87	%	TLT07_V1	TPT LABCO	TOBACCO	AS-IS	0.12	3	Week 24	3

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