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The first pt.xpt 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 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 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 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.
  • 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. 
  • In this example, the applicant chose to sub-categorize some constituents using the permissible variable PTSCAT (Sub-Category of Test).
Dataset wrap
Namept
Rowcaps
Row 1:Shows the PTTEST of Product Moisture which reflects the percentage of moisture in the substance for the condition noted in STOCONID which is Condition 1.  Product Moisture is sometimes referred to as "Oven Volatiles".
Rows 4, 6, 8:Show the NNK, NNN, and TSN tests with the tobacco product "AS-IS" using the PTSPCCND to show that the tobacco is "FRESH".
Rows 5, 7, 9:Show the NNK, NNN, and TSN tests with the tobacco product as "DRY WEIGHT BASIS" (DWB) using the PTSPCCND to show that the tobacco is "DRIED".
Rows 2-11:Show the other analytes used in testing (pH, water activity, NNK, NNN, TSNA, etc.) using the PTTEST and PTTESTCD variables.
Dataset2
RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PTSmokeless01Condition 11PRODMSTProduct MoistureSTABILITY STUDY52.0%
52.052.0%TLT07_V1TPT LABCOTOBACCO

1Week 01
2TOB07PTSmokeless01Condition 12PHpHSTABILITY STUDY8.06

8.068.06
TL009_V1TPT LABCOTOBACCO

1Week 01
3TOB07PTSmokeless01Condition 13H2OACTWater ActivitySTABILITY STUDY0.86

0.860.86
TLPH01_V1TPT LABCOTOBACCO

1Week 01
4TOB07PTSmokeless01Condition 14NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDY1.0225ug/g
1.02251.0225ug/gTL026_V12.2TPT LABCOTOBACCO, FRESHAS-IS
1Week 01
5TOB07PTSmokeless01Condition 15NNKNicotine-Derived Nitrosamine KetoneSTABILITY STUDY0.4908ug/g
0.49080.4908ug/gTL026_V12.2TPT LABCOTOBACCO, DRIEDDRY WEIGHT
1Week 01
6TOB07PTSmokeless01Condition 16NNNN-NitrosonornicotineSTABILITY STUDY4.4633ug/g
4.46334.4633ug/gTL026_V12.2TPT LABCOTOBACCO, FRESHAS-IS
1Week 01
7TOB07PTSmokeless01Condition 17NNNN-NitrosonornicotineSTABILITY STUDY2.1424ug/g
2.14242.1424ug/gTL026_V12.2TPT LABCOTOBACCO, DRIEDDRY WEIGHT
1Week 01
10TOB07PTSmokeless01Condition 18AEBPLCTAerobic Plate CountSTABILITY STUDY154000CFU/g
154000154000CFU/gTLMB_V1.1TPT LABCOTOBACCO

1Week 01
11TOB07PTSmokeless01Condition 19TYMCTotal Yeast and/or Mold CountSTABILITY STUDY<10CFU/g
<10<10CFU/gTLMB_V1.1TPT LABCOTOBACCO

1Week 01

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