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The following example illustrates stability study results for an ENDS tobacco product. Stability study results are represented in the PT domain, with PTCAT = STABILITY STUDY.

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.

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.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONDIDPTSEQPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PT111
Condition 1

1

NICOTINENicotineSTABILITY STUDY
35.94mg/g
35.9435.94mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
2TOB07PT111PUFFMASTER3KCondition 12NICOTINENicotineSTABILITY STUDY

0.1039

mg/PUFF
0.10390.1039mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
3TOB07PT111
Condition 13NORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant25.76ug/g
25.7625.76ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
4TOB07PT111PUFFMASTER3KCondition 14NORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant0.0392ug/PUFF
0.03920.0392ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
5TOB07PT111
Condition 15GLYCRLGlycerolSTABILITY STUDYPrimary Ingredient615.68mg/g
615.68615.68mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
6TOB07PT111PUFFMASTER3KCondition 16GLYCRLGlycerolSTABILITY STUDYPrimary Ingredient1.81mg/PUFF0.001441.811.81mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
7TOB07PT111
Condition 17PRPYLGLYPropylene GlycolSTABILITY STUDYPrimary Ingredient218.21mg/g
218.21218.21mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
8TOB07PT111PUFFMASTER3KCondition 18PRPYLGLYPropylene GlycolSTABILITY STUDYPrimary Ingredient0.8565mg/PUFF0.000240.85650.8565mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
9TOB07PT111
Condition 19BNZOICACBenzoic AcidSTABILITY STUDYAcid42.2ug/PUFF
42.242.2ug/PUFFTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
10TOB07PT111
Condition 110MENTHOLMentholSTABILITY STUDYFlavorant37.53mg/g
37.5337.53mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
11TOB07PT111PUFFMASTER3KCondition 111MENTHOLMentholSTABILITY STUDYFlavorant0.5881mg/PUFF0.000240.58810.5881mg/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
12TOB07PT111PUFFMASTER3KCondition 112GLYCDOLGlycidolSTABILITY STUDYStabilizerNOT DETECTED
0.00011NOT DETECTED

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
13TOB07PT111PUFFMASTER3KCondition 113FRMLDHDFormaldehydeSTABILITY STUDY
0.0728ug/PUFF0.005490.07280.0728ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
14TOB07PT111PUFFMASTER3KCondition 114ACROLNAcrolienSTABILITY STUDY
DETECTED, BELOW LLOQ
0.00928DETECTED, BELOW LLOQ

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
15TOB07PT111
Condition 115LACTICACLactic AcidSTABILITY STUDY
40.44ug/g
40.4440.44ug/gTPT LABCOTLEL01_v1.5.pdf

E-LIQUID

0.0011Week 01
16TOB07PT111PUFFMASTER3KCondition 116LACTICACLactic AcidSTABILITY STUDY
29.71ug/PUFF0.28429.7129.71ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
17TOB07PT111
Condition 117VANLLNVanillinSTABILITY STUDYFlavorant1.12ug/g
1.121.12ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
18TOB07PT111
Condition 118NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDYHPHC0.0711ug/g
0.07110.0711ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
19TOB07PT111
Condition 119NNNN-NitrosonornicotineSTABILITY STUDYHPHC0.0852ug/g
0.08520.0852ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
20TOB07PT111PUFFMASTER3KCondition 120NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDYHPHC0.0577ug/PUFF
0.05770.0577ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
21TOB07PT111PUFFMASTER3KCondition 121NNNN-NitrosonornicotineSTABILITY STUDYHPHC0.0742ug/PUFF
0.07420.0742ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
22TOB07PT111
Condition 122NICKELNickelSTABILITY STUDYExtractables / Leachables0.0897ug/g
0.08970.0897ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
23TOB07PT111PUFFMASTER3KCondition 123MASSMassSTABILITY STUDY
3.87mg/PUFF0.00713.873.87mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
24TOB07PT111
Condition 124CHROMIUMChromiumSTABILITY STUDY
NOT DETECTED

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
25TOB07PT111
Condition 125PHpHSTABILITY STUDY
7.15

7.157.15
TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
26TOB07PT111PUFFMASTER3KCondition 126PHpHSTABILITY STUDY
7.24

7.247.24
TPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
27TOB07PT111
Condition 127ENDTXNEndotoxinSTABILITY STUDYToxinsNOT DETECTED

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
28TOB07PT111
Condition 128AEBPLCTAerobic Plate CountSTABILITY STUDYMicrobiological<1CFU/mL
<1
CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
29TOB07PT111
Condition 129TYMCTotal Yeast and/or Mold CountSTABILITY STUDYMicrobiological1CFU/mL
11CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
30TOB07PT111
Condition 130ACTALDAcetaldehydeSTABILITY STUDYAldehyde7.8ug/mL
7.87.8ug/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
31TOB07PT111
Condition 131ACTPROPNAcetyl PropionylSTABILITY STUDYDiketone32.4ug/mL
32.432.4ug/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points.  In the interest of brevity for this example, only portions of the content using the TEST of Nicotine is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1,  Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/puff is valid.

Rows 1-9:Show the PTTEST of Nicotine for Condition 1 which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test.
Rows 10-19:Show the PTTEST of Nicotine for Condition 2 across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.
Rows 20-27:Show the PTTEST of Nicotine for Condition 3 across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.

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pt.xpt

Row

STUDYID

DOMAINSPTOBIDSTOCONIDPTSEQPTGRPIDPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTREPNUMPTTPTPTTPTNUM
1TOB07PT111Condition 12111NICOTINE

Nicotine

35.94mg/g35.9435.94mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 01
2TOB07PT111Condition 12121

NICOTINE

Nicotine35.46mg/g35.4635.46mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID2Week 01
3TOB07PT111Condition 12131NICOTINENicotine35.97mg/g35.9735.97mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 01
4TOB07PT111Condition 12141NICOTINENicotine35.55mg/g35.5535.55mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 244
5TOB07PT111Condition 12151NICOTINENicotine35.88mg/g35.8835.88mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID2Week 244
6TOB07PT111Condition 12161NICOTINENicotine35.67mg/g35.6735.67mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 244
7TOB07PT111Condition 12171NICOTINENicotine36.11mg/g36.1136.11mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 529
8TOB07PT111Condition 12181NICOTINENicotine35.72mg/g35.7235.72mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID2Week 529
9TOB07PT111Condition 12191NICOTINENicotine35.54mg/g35.5435.54mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 529
10TOB07PT111Condition 22203NICOTINE

Nicotine

0.1039mg/PUFF0.10390.1039mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 01
11TOB07PT111Condition 22213NICOTINENicotine0.1142mg/PUFF0.11420.1142mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 01
12TOB07PT111Condition 22223NICOTINENicotine0.1282mg/PUFF0.12820.1282mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 01
13TOB07PT111Condition 22233NICOTINENicotine0.1242mg/PUFF0.12420.1242mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 244
14TOB07PT111Condition 22243NICOTINENicotine0.1084mg/PUFF0.10840.1084mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 244
15TOB07PT111Condition 22253NICOTINENicotine0.1174mg/PUFF0.11740.1174mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 244
16TOB07PT111Condition 22263NICOTINENicotine0.1374mg/PUFF0.13740.1374mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 529
17TOB07PT111Condition 22273NICOTINENicotine0.1364mg/PUFF0.13640.1364mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 529
18TOB07PT111Condition 22283NICOTINENicotine0.1264mg/PUFF0.12640.1264mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 529
19TOB07PT111Condition 22293NICOTINENicotine0.1256mg/PUFF0.12560.1256mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 01
20TOB07PT111Condition 32304NICOTINENicotine0.1236mg/PUFF0.12360.1236mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 01
21TOB07PT111Condition 32314NICOTINENicotine0.1126mg/PUFF0.11260.1126mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 01
22TOB07PT111Condition 32324NICOTINENicotine0.1334mg/PUFF0.13340.1334mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 244
23TOB07PT111Condition 32334NICOTINENicotine0.1134mg/PUFF0.11340.1134mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 244
24TOB07PT111Condition 32344NICOTINENicotine0.1125mg/PUFF0.11250.1125mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 244
25TOB07PT111Condition 32354NICOTINENicotine0.1156mg/PUFF0.11560.1156mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 529
26TOB07PT111Condition 32364NICOTINENicotine0.1145mg/PUFF0.11450.1145mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 529
27TOB07PT111Condition 32374NICOTINENicotine0.1157mg/PUFF0.11570.1157mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 529
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID/Storage Condition ID represents the storage condition. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.

es.xpt

es.xpt

RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
1

TOB07

ESCondition 11HUMIDHumidity37%
2

TOB07

ESCondition 12TEMPTemperature24C
3

TOB07

ESCondition 21HUMIDHumidity60%
4

TOB07

ESCondition 22TEMPTemperature27C
5

TOB07

ESCondition 31HUMIDHumidity95%
6

TOB07

ESCondition 32TEMPTemperature31C
$warningHtml

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