Versions Compared

Old Version 104

changes.mady.by.user Jon Neville

Saved on

compared with

New Version 105

changes.mady.by.user Jon Neville

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Info

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-156
The first pt.xpt dataset shows 22 constituents consituents and 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. 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 3.1.3.2, 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 consituents and parameters using the permissible variable PTSCAT (Sub-Category of Test).
Dataset wrap
Namept
Rowcaps
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/parameters in aerosol produced from the e-liquid product. The smoking machine is shown in SPDEVID and the regimen is shown in PTREFID.
Dataset2
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 

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-109

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

...