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The following example illustrates stability study results for an ENDS tobacco product TOBA-107 - Getting issue details... STATUS . Stability study results are represented in the PT domain, with PTCAT = STABILITY STUDY.

TOBA-156 - Getting issue details... STATUS 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.

  • 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 3.1.3.2, HPHCs, Other Constituents, and Smoking Regimens.
  • PTXFN (External File Path) is used to document the location or file name within the submission that contains the lab methodology protocol used to assay the associated constituent when such methodology is too complex for the single PTMETHOD variable.
  • 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).

Rows 1, 3, 5, 7, 9, 10, 15, 17-19, 22, 24, 25, 27-31:Show the results of testing for constituents in samples of e-liquid product (PTSPEC=E-LIQUID).
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.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSPDEVIDSTOCONDIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTLLODPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PT111
Condition 1

1


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

0.1039

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

Nornicotine

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

Nornicotine

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

AEROSOL

0.0011Week 01
12TOB07PT111PUFFMASTER3KCondition 112NON-INTENSE REGIMENGLYCDOLGlycidolSTABILITY STUDYStabilizerNOT DETECTED
0.00011NOT DETECTED

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
13TOB07PT111PUFFMASTER3KCondition 113NON-INTENSE REGIMENFRMLDHDFormaldehydeSTABILITY STUDY
0.0728ug/PUFF0.005490.07280.0728ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

0.0011Week 01
14TOB07PT111PUFFMASTER3KCondition 114NON-INTENSE REGIMENACROLNAcrolienSTABILITY STUDY
DETECTED, BELOW LLOQ
0.00928DETECTED, BELOW LLOQ

TPT LABCOTLAE01_v2.1.pdf

AEROSOL

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

E-LIQUID

0.0011Week 01
16TOB07PT111PUFFMASTER3KCondition 116NON-INTENSE REGIMENLACTICACLactic AcidSTABILITY STUDY
29.71ug/PUFF0.28429.7129.71ug/PUFFTPT LABCOTLAE01_v2.1.pdf

AEROSOL

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

NOT DETECTED

TPT LABCOTLEL01_v1.5.pdfE-LIQUID0.0011Week 01
25TOB07PT111
Condition 125
PH

pH  TOBA-109 - Jira project doesn't exist or you don't have permission to view it.

STABILITY STUDY
7.15

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

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

NOT DETECTED

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

Dataset Debug Messages

  • When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.
  • There is a leading, trailing, or non-breaking space in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The second pt.xpt dataset shows testing for just one constituent, nicotine, performed in three replicates (note the values of PTREPNUM), at the first three time points of the study (as shown in PTTPT / PTTPTNUM), from three sets of storage conditions (STOCONID TOBA-124 - Getting issue details... STATUS ), 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. 

pt.xpt

pt.xpt

Row

STUDYID

DOMAINSPTOBIDSPDEVIDSTOCONIDPTSEQPTREFIDPTTESTCDPTTESTPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTNAMPTXFNPTSPECPTREPNUMPTTPTPTTPTNUM
1TOB07PT111
Condition 1211
NICOTINE

Nicotine

35.94mg/g35.9435.94mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 01
2TOB07PT111
Condition 1212


NICOTINE

Nicotine35.46mg/g35.4635.46mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID2Week 01
3TOB07PT111
Condition 1213
NICOTINENicotine35.97mg/g35.9735.97mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 01
4TOB07PT111
Condition 1214
NICOTINENicotine35.55mg/g35.5535.55mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 82
5TOB07PT111
Condition 1215
NICOTINENicotine35.88mg/g35.8835.88mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID2Week 82
6TOB07PT111
Condition 1216
NICOTINENicotine35.67mg/g35.6735.67mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 82
7TOB07PT111
Condition 1217
NICOTINENicotine36.11mg/g36.1136.11mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID1Week 243
8TOB07PT111
Condition 1218
NICOTINENicotine35.72mg/g35.7235.72mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID2Week 243
9TOB07PT111
Condition 1219
NICOTINENicotine35.54mg/g35.5435.54mg/gTPT LABCOTLEL01_v1.5.pdfE-LIQUID3Week 243
10TOB07PT111PUFFMASTER3KCondition 2220NON-INTENSE REGIMENNICOTINE

Nicotine

0.1039mg/PUFF0.10390.1039mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 01
11TOB07PT111PUFFMASTER3KCondition 2221NON-INTENSE REGIMENNICOTINENicotine0.1142mg/PUFF0.11420.1142mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 01
12TOB07PT111PUFFMASTER3KCondition 2222NON-INTENSE REGIMENNICOTINENicotine0.1282mg/PUFF0.12820.1282mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 01
13TOB07PT111PUFFMASTER3KCondition 2223NON-INTENSE REGIMENNICOTINENicotine0.1242mg/PUFF0.12420.1242mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 82
14TOB07PT111PUFFMASTER3KCondition 2224NON-INTENSE REGIMENNICOTINENicotine0.1084mg/PUFF0.10840.1084mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 82
15TOB07PT111PUFFMASTER3KCondition 2225NON-INTENSE REGIMENNICOTINENicotine0.1174mg/PUFF0.11740.1174mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 82
16TOB07PT111PUFFMASTER3KCondition 2226NON-INTENSE REGIMENNICOTINENicotine0.1374mg/PUFF0.13740.1374mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 243
17TOB07PT111PUFFMASTER3KCondition 2227NON-INTENSE REGIMENNICOTINENicotine0.1364mg/PUFF0.13640.1364mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 243
18TOB07PT111PUFFMASTER3KCondition 2228NON-INTENSE REGIMENNICOTINENicotine0.1264mg/PUFF0.12640.1264mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 243
19TOB07PT111PUFFMASTER3KCondition 2229NON-INTENSE REGIMENNICOTINENicotine0.1256mg/PUFF0.12560.1256mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 01
20TOB07PT111PUFFMASTER3KCondition 3230NON-INTENSE REGIMENNICOTINENicotine0.1236mg/PUFF0.12360.1236mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 01
21TOB07PT111PUFFMASTER3KCondition 3231NON-INTENSE REGIMENNICOTINENicotine0.1126mg/PUFF0.11260.1126mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 01
22TOB07PT111PUFFMASTER3KCondition 3232NON-INTENSE REGIMENNICOTINENicotine0.1334mg/PUFF0.13340.1334mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 82
23TOB07PT111PUFFMASTER3KCondition 3233NON-INTENSE REGIMENNICOTINENicotine0.1134mg/PUFF0.11340.1134mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 82
24TOB07PT111PUFFMASTER3KCondition 3234NON-INTENSE REGIMENNICOTINENicotine0.1125mg/PUFF0.11250.1125mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 82
25TOB07PT111PUFFMASTER3KCondition 3235NON-INTENSE REGIMENNICOTINENicotine0.1156mg/PUFF0.11560.1156mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL1Week 243
26TOB07PT111PUFFMASTER3KCondition 3236NON-INTENSE REGIMENNICOTINENicotine0.1145mg/PUFF0.11450.1145mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL2Week 243
27TOB07PT111PUFFMASTER3KCondition 3237NON-INTENSE REGIMENNICOTINENicotine0.1157mg/PUFF0.11570.1157mg/puffTPT LABCOTLAE01_v2.1.pdfAEROSOL3Week 243
$warningHtml

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.

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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