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The first dataset shows 22 constituents 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. Some constituent names (Values of PTTESTCD/PTTEST) appear multiple times twice 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.

Note
  • The use of SPDEVID and PTREFID in this example on records where PTSPEC=AEROSOL indicates that a smoking machine (shown in SPDEVID) was used to perform a the smoking regimen (shown in PTREFID) to produce the aerosol from the e-liquid product on records where PTSPEC=AEROSOL. Details of the smoking machine and smoking regimen are not shown herein this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.1, Harmful  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. 
Dataset wrap
Namept
Rowcaps
Rows: 1,3,5,,, 9-31:Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in STOCONDID which is Condition 1. 10,27-31
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.
Dataset2
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

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