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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 both 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.

  • 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. Details of the smoking machine and smoking regimen are not shown here. 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.
  • STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details of these conditions are represented in the ES dataset example that follows the two PT dataset examples. 

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, 11-14, 16, 20, 21, 23, 26:Show the results of testing for constituents in aerosol produced from the e-liquid product. The smoking machine is shown in SPDEVID and the regimen is shown in PTREFID.
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

RowSTUDYIDDOMAINSPDEVIDSPTOBIDSTOCONDIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PT
111Condition 1

1


NICOTINENicotineSTABILITY STUDY
35.94mg/g
35.9435.94mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
2TOB07PTPUFFMASTER3K111Condition 12NON-INTENSE REGIMENNICOTINENicotineSTABILITY STUDY

0.1039

mg/PUFF
0.10390.1039mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
3TOB07PT
111Condition 13
NORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant25.76ug/g
25.7625.76ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
4TOB07PTPUFFMASTER3K111Condition 14NON-INTENSE REGIMENNORNCTN

Nornicotine

STABILITY STUDYNicotine Degradant0.0392ug/PUFF
0.03920.0392ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
5TOB07PT
111Condition 15
GLYCRLGlycerolSTABILITY STUDYPrimary Ingredient615.68mg/g
615.68615.68mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
6TOB07PTPUFFMASTER3K111Condition 16NON-INTENSE REGIMENGLYCRLGlycerolSTABILITY STUDYPrimary Ingredient1.81mg/PUFF0.001441.811.81mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
7TOB07PT
111Condition 17
PRPYLGLYPropylene GlycolSTABILITY STUDYPrimary Ingredient218.21mg/g
218.21218.21mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
8TOB07PTPUFFMASTER3K111Condition 18NON-INTENSE REGIMENPRPYLGLYPropylene GlycolSTABILITY STUDYPrimary Ingredient0.8565mg/PUFF0.000240.85650.8565mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
9TOB07PT
111Condition 19
BNZOICACBenzoic AcidSTABILITY STUDYAcid42.2ug/PUFF
42.242.2ug/PUFFTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
10TOB07PT
111Condition 110
MENTHOLMentholSTABILITY STUDYFlavorant37.53mg/g
37.5337.53mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
11TOB07PTPUFFMASTER3K111Condition 111NON-INTENSE REGIMENMENTHOLMentholSTABILITY STUDYFlavorant0.5881mg/PUFF0.000240.58810.5881mg/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
12TOB07PTPUFFMASTER3K111Condition 112NON-INTENSE REGIMENGLYCDOLGlycidolSTABILITY STUDYStabilizerNOT DETECTED
0.00011NOT DETECTED

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
13TOB07PTPUFFMASTER3K111Condition 113NON-INTENSE REGIMENFRMLDHDFormaldehydeSTABILITY STUDY
0.0728ug/PUFF0.005490.07280.0728ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
14TOB07PTPUFFMASTER3K111Condition 114NON-INTENSE REGIMENACROLNAcrolienSTABILITY STUDY
DETECTED, BELOW LLOQ
0.00928DETECTED, BELOW LLOQ

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
15TOB07PT
111Condition 115
LACTICACLactic AcidSTABILITY STUDY
40.44ug/g
40.4440.44ug/gTPT LABCOTLEL01_v1.5.pdf

E-LIQUID

0.0011Week 01
16TOB07PTPUFFMASTER3K111Condition 116NON-INTENSE REGIMENLACTICACLactic AcidSTABILITY STUDY
29.71ug/PUFF0.28429.7129.71ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
17TOB07PT
111Condition 117
VANLLNVanillinSTABILITY STUDYFlavorant1.12ug/g
1.121.12ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
18TOB07PT
111Condition 118
NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDYHPHC0.0711ug/g
0.07110.0711ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
19TOB07PT
111Condition 119
NNNN-NitrosonornicotineSTABILITY STUDYHPHC0.0852ug/g
0.08520.0852ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
20TOB07PTPUFFMASTER3K111Condition 120NON-INTENSE REGIMENNNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDYHPHC0.0577ug/PUFF
0.05770.0577ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
21TOB07PTPUFFMASTER3K111Condition 121NON-INTENSE REGIMENNNNN-NitrosonornicotineSTABILITY STUDYHPHC0.0742ug/PUFF
0.07420.0742ug/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
22TOB07PT
111Condition 122
NICKELNickelSTABILITY STUDYExtractables / Leachables0.0897ug/g
0.08970.0897ug/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
23TOB07PTPUFFMASTER3K111Condition 123NON-INTENSE REGIMENMASSMassSTABILITY STUDY
3.87mg/PUFF0.00713.873.87mg/PUFFTPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
24TOB07PT
111Condition 124
CHROMIUMChromiumSTABILITY STUDY
NOT DETECTED

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
25TOB07PT
111Condition 125
PHpHSTABILITY STUDY
7.15

7.157.15
TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
26TOB07PTPUFFMASTER3K111Condition 126NON-INTENSE REGIMENPHpHSTABILITY STUDY
7.24

7.247.24
TPT LABCOTLAE01_v2.1.pdfAEROSOL0.0011Week 01
27TOB07PT
111Condition 127
ENDTXNEndotoxinSTABILITY STUDYToxinsNOT DETECTED

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
28TOB07PT
111Condition 128
AEBPLCTAerobic Plate CountSTABILITY STUDYMicrobiological<1CFU/mL
<1
CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
29TOB07PT
111Condition 129
TYMCTotal Yeast and/or Mold CountSTABILITY STUDYMicrobiological1CFU/mL
11CFU/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
30TOB07PT
111Condition 130
ACTALDAcetaldehydeSTABILITY STUDYAldehyde7.8ug/mL
7.87.8ug/mLTPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
31TOB07PT
111Condition 131
ACTPROPNAcetyl 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.

pt.xpt

pt.xpt

Row

STUDYID

DOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTREPNUMPTTPTPTTPTNUM
1TOB07PT111Condition 1211NICOTINE

Nicotine

35.94mg/g35.9435.94mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 01
2TOB07PT111Condition 1212

NICOTINE

Nicotine35.46mg/g35.4635.46mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID2Week 01
3TOB07PT111Condition 1213NICOTINENicotine35.97mg/g35.9735.97mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 01
4TOB07PT111Condition 1214NICOTINENicotine35.55mg/g35.5535.55mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 244
5TOB07PT111Condition 1215NICOTINENicotine35.88mg/g35.8835.88mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID2Week 244
6TOB07PT111Condition 1216NICOTINENicotine35.67mg/g35.6735.67mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 244
7TOB07PT111Condition 1217NICOTINENicotine36.11mg/g36.1136.11mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 529
8TOB07PT111Condition 1218NICOTINENicotine35.72mg/g35.7235.72mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID2Week 529
9TOB07PT111Condition 1219NICOTINENicotine35.54mg/g35.5435.54mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 529
10TOB07PT111Condition 2220NICOTINE

Nicotine

0.1039mg/PUFF0.10390.1039mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 01
11TOB07PT111Condition 2221NICOTINENicotine0.1142mg/PUFF0.11420.1142mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 01
12TOB07PT111Condition 2222NICOTINENicotine0.1282mg/PUFF0.12820.1282mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 01
13TOB07PT111Condition 2223NICOTINENicotine0.1242mg/PUFF0.12420.1242mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 244
14TOB07PT111Condition 2224NICOTINENicotine0.1084mg/PUFF0.10840.1084mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 244
15TOB07PT111Condition 2225NICOTINENicotine0.1174mg/PUFF0.11740.1174mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 244
16TOB07PT111Condition 2226NICOTINENicotine0.1374mg/PUFF0.13740.1374mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 529
17TOB07PT111Condition 2227NICOTINENicotine0.1364mg/PUFF0.13640.1364mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 529
18TOB07PT111Condition 2228NICOTINENicotine0.1264mg/PUFF0.12640.1264mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 529
19TOB07PT111Condition 2229NICOTINENicotine0.1256mg/PUFF0.12560.1256mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 01
20TOB07PT111Condition 3230NICOTINENicotine0.1236mg/PUFF0.12360.1236mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 01
21TOB07PT111Condition 3231NICOTINENicotine0.1126mg/PUFF0.11260.1126mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 01
22TOB07PT111Condition 3232NICOTINENicotine0.1334mg/PUFF0.13340.1334mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 244
23TOB07PT111Condition 3233NICOTINENicotine0.1134mg/PUFF0.11340.1134mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 244
24TOB07PT111Condition 3234NICOTINENicotine0.1125mg/PUFF0.11250.1125mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 244
25TOB07PT111Condition 3235NICOTINENicotine0.1156mg/PUFF0.11560.1156mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 529
26TOB07PT111Condition 3236NICOTINENicotine0.1145mg/PUFF0.11450.1145mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 529
27TOB07PT111Condition 3237NICOTINENicotine0.1157mg/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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