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The first pt.xpt dataset shows 22 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 e-liquid and aerosol tobacco "as-is" and dried tobacco (as indicated by PTSPEC / PTSPECCND). 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

    *DWB=Dry weight basis. The DWB normalizes the results since starting moisture may vary.

    Info

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

    Note

    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 moisture content using the TEST of Product Moisture (also known as Oven Volatile) percentage 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.

    Dataset wrap
    Namept
    Rowcaps
    Rows 1-9:Show the PTTEST of Product Moisture for Condition 1 which is shown in STOCONID. The sample of various timepoints that may be used in the testing for product moisture 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 10-18:Show the PTTEST of Product Moisture for Condition 2 across the same timepoints shown for Condition 1. 
    Dataset2
    RowSTUDYIDDOMAINSPTOBIDSTOCONIDPTSEQPTTESTCDPTTESTPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTSPCCNDPTLLOQPTREPNUMPTTPTPTTPTNUM
    1TOB07PTSmokeless01Condition 1111PRODMSTProduct Moisture51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.121Week 01
    2TOB07PTSmokeless01Condition 1112PRODMSTProduct Moisture51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.122Week 01
    3TOB07PTSmokeless01Condition 1113PRODMSTProduct Moisture51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.123Week 01
    4TOB07PTSmokeless01Condition 1114PRODMSTProduct Moisture51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.121Week 84
    5TOB07PTSmokeless01Condition 1115PRODMSTProduct Moisture51.75%0.151.7551.75%TLT07_V1TPT LABCOTOBACCOAS-IS0.122Week 84
    6TOB07PTSmokeless01Condition 1116PRODMSTProduct Moisture51.67%0.151.6751.67%TLT07_V1TPT LABCOTOBACCOAS-IS0.123Week 84
    7TOB07PTSmokeless01Condition 1117PRODMSTProduct Moisture52.05%0.152.0552.05%TLT07_V1TPT LABCOTOBACCOAS-IS0.121Week 489
    8TOB07PTSmokeless01Condition 1118PRODMSTProduct Moisture52.68%0.152.6852.68%TLT07_V1TPT LABCOTOBACCOAS-IS0.122Week 489
    9TOB07PTSmokeless01Condition 1119PRODMSTProduct Moisture52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.123Week 489
    10TOB07PTSmokeless01Condition 2120PRODMSTProduct Moisture51.93%0.151.9351.93%TLT07_V1TPT LABCOTOBACCOAS-IS0.121Week 01
    11TOB07PTSmokeless01Condition 2121PRODMSTProduct Moisture51.96%0.151.9651.96%TLT07_V1TPT LABCOTOBACCOAS-IS0.122Week 01
    12TOB07PTSmokeless01Condition 2122PRODMSTProduct Moisture51.98%0.151.9851.98%TLT07_V1TPT LABCOTOBACCOAS-IS0.123Week 01
    13TOB07PTSmokeless01Condition 2123PRODMSTProduct Moisture51.80%0.151.8051.80%TLT07_V1TPT LABCOTOBACCOAS-IS0.121Week 84
    14TOB07PTSmokeless01Condition 2124PRODMSTProduct Moisture51.77%0.151.7751.77%TLT07_V1TPT LABCOTOBACCOAS-IS0.122Week 84
    15TOB07PTSmokeless01Condition 2125PRODMSTProduct Moisture51.84%0.151.8451.84%TLT07_V1TPT LABCOTOBACCOAS-IS0.123Week 84
    16TOB07PTSmokeless01Condition 2126PRODMSTProduct Moisture52.18%0.152.1852.18%TLT07_V1TPT LABCOTOBACCOAS-IS0.121Week 489
    17TOB07PTSmokeless01Condition 2127PRODMSTProduct Moisture52.21%0.152.2152.21%TLT07_V1TPT LABCOTOBACCOAS-IS0.122Week 489
    18TOB07PTSmokeless01Condition 2128PRODMSTProduct Moisture51.87%0.151.8751.87%TLT07_V1TPT LABCOTOBACCOAS-IS0.123Week 489

    The storage conditions details of "E-Liquid Standard (Long Term) Condition 1" and "E-Liquid Standard (Long Term) Condition 1" Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID

    ...

    /Storage Condition ID

    ...

    represents the storage condition and links to the PT datasets above by matching values of STOCONID there. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU. The es.xpt dataset below shows all three sets of storage conditions used across both pt.xpt dataset examples above..

    Dataset wrap
    Namees
    Dataset2
    RowSTUDYIDDOMAINSTOCONIDESSEQESPARMCDESPARMESVALESVALU
    1

    TOB07

    		ESCondition 11HUMIDHumidity37%
    2

    TOB07

    		ESCondition 12TEMPTemperature24C
    3

    TOB07

    		ESCondition 21HUMIDHumidity85%
    4

    TOB07

    		ESCondition 22TEMPTemperature27C