The following example illustrates stability study results for an ENDS tobacco product. Stability study results are represented in the Tobacco Product Testing (PT) domain, with PTCAT = STABILITY TESTING.
The first pt.xpt dataset shows 22 consituents and parameters each as a single replicate (PTREPNUM=1), at 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from 1 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 vaping regimen (shown in PTREFID) to produce the aerosol from the e-liquid product on records where PTSPEC=AEROSOL. Details of the smoking machine and vaping 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 / Vaping 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 Environmental Storage Conditions (ES) dataset example that follows the 2 PT dataset examples.
In this example, the applicant chose to subcategorize some consituents and parameters using the permissible variable PTSCAT (Sub-Category of Test).
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.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
SPDEVID
STOCONDID
PTSEQ
PTREFID
PTTESTCD
PTTEST
PTCAT
PTSCAT
PTORRES
PTORRESU
PTLLOD
PTSTRESC
PTSTRESN
PTSTRESU
PTNAM
PTXFN
PTSPEC
PTLLOQ
PTREPNUM
PTDTC
PTTPT
PTTPTNUM
1
TOB07
PT
111
Condition 1
1
NICOTINE
Nicotine
STABILITY TESTING
35.94
mg/g
35.94
35.94
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
2
TOB07
PT
111
PUFFMASTER3K
Condition 1
2
NON-INTENSE REGIMEN
NICOTINE
Nicotine
STABILITY TESTING
0.1039
mg/PUFF
0.1039
0.1039
mg/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
3
TOB07
PT
111
Condition 1
3
NORNCTN
Nornicotine
STABILITY TESTING
Nicotine Degradant
25.76
ug/g
25.76
25.76
ug/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
4
TOB07
PT
111
PUFFMASTER3K
Condition 1
4
NON-INTENSE REGIMEN
NORNCTN
Nornicotine
STABILITY TESTING
Nicotine Degradant
0.0392
ug/PUFF
0.0392
0.0392
ug/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
5
TOB07
PT
111
Condition 1
5
GLYCRL
Glycerol
STABILITY TESTING
Primary Ingredient
615.68
mg/g
615.68
615.68
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
6
TOB07
PT
111
PUFFMASTER3K
Condition 1
6
NON-INTENSE REGIMEN
GLYCRL
Glycerol
STABILITY TESTING
Primary Ingredient
1.81
mg/PUFF
0.00144
1.81
1.81
mg/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
7
TOB07
PT
111
Condition 1
7
PRPYLGLY
Propylene Glycol
STABILITY TESTING
Primary Ingredient
218.21
mg/g
218.21
218.21
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
8
TOB07
PT
111
PUFFMASTER3K
Condition 1
8
NON-INTENSE REGIMEN
PRPYLGLY
Propylene Glycol
STABILITY TESTING
Primary Ingredient
0.8565
mg/PUFF
0.00024
0.8565
0.8565
mg/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
9
TOB07
PT
111
Condition 1
9
BNZOICAC
Benzoic Acid
STABILITY TESTING
Acid
42.2
ug/PUFF
42.2
42.2
ug/PUFF
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
10
TOB07
PT
111
Condition 1
10
MENTHOL
Menthol
STABILITY TESTING
Flavorant
37.53
mg/g
37.53
37.53
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
11
TOB07
PT
111
PUFFMASTER3K
Condition 1
11
NON-INTENSE REGIMEN
MENTHOL
Menthol
STABILITY TESTING
Flavorant
0.5881
mg/PUFF
0.00024
0.5881
0.5881
mg/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
12
TOB07
PT
111
PUFFMASTER3K
Condition 1
12
NON-INTENSE REGIMEN
GLYCDOL
Glycidol
STABILITY TESTING
Stabilizer
NOT DETECTED
0.00011
NOT DETECTED
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
13
TOB07
PT
111
PUFFMASTER3K
Condition 1
13
NON-INTENSE REGIMEN
FRMLDHD
Formaldehyde
STABILITY TESTING
0.0728
ug/PUFF
0.00549
0.0728
0.0728
ug/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
14
TOB07
PT
111
PUFFMASTER3K
Condition 1
14
NON-INTENSE REGIMEN
ACROLN
Acrolien
STABILITY TESTING
DETECTED, BELOW LLOQ
0.00928
DETECTED, BELOW LLOQ
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
15
TOB07
PT
111
Condition 1
15
LACTICAC
Lactic Acid
STABILITY TESTING
40.44
ug/g
40.44
40.44
ug/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
16
TOB07
PT
111
PUFFMASTER3K
Condition 1
16
NON-INTENSE REGIMEN
LACTICAC
Lactic Acid
STABILITY TESTING
29.71
ug/PUFF
0.284
29.71
29.71
ug/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
17
TOB07
PT
111
Condition 1
17
VANLLN
Vanillin
STABILITY TESTING
Flavorant
1.12
ug/g
1.12
1.12
ug/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
18
TOB07
PT
111
Condition 1
18
NNK
Nicotine-Derived Nitrosamine Ketone
STABILITY TESTING
HPHC
0.0711
ug/g
0.0711
0.0711
ug/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
19
TOB07
PT
111
Condition 1
19
NNN
N-Nitrosonornicotine
STABILITY TESTING
HPHC
0.0852
ug/g
0.0852
0.0852
ug/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
20
TOB07
PT
111
PUFFMASTER3K
Condition 1
20
NON-INTENSE REGIMEN
NNK
Nicotine-Derived Nitrosamine Ketone
STABILITY TESTING
HPHC
0.0577
ug/PUFF
0.0577
0.0577
ug/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
21
TOB07
PT
111
PUFFMASTER3K
Condition 1
21
NON-INTENSE REGIMEN
NNN
N-Nitrosonornicotine
STABILITY TESTING
HPHC
0.0742
ug/PUFF
0.0742
0.0742
ug/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
22
TOB07
PT
111
Condition 1
22
NICKEL
Nickel
STABILITY TESTING
Extractables / Leachables
0.0897
ug/g
0.0897
0.0897
ug/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
23
TOB07
PT
111
PUFFMASTER3K
Condition 1
23
NON-INTENSE REGIMEN
MASS
Mass
STABILITY TESTING
3.87
mg/PUFF
0.0071
3.87
3.87
mg/PUFF
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
24
TOB07
PT
111
Condition 1
24
CHROMIUM
Chromium
STABILITY TESTING
NOT DETECTED
NOT DETECTED
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
25
TOB07
PT
111
Condition 1
25
PH
pH
STABILITY TESTING
7.15
7.15
7.15
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
26
TOB07
PT
111
PUFFMASTER3K
Condition 1
26
NON-INTENSE REGIMEN
PH
pH
STABILITY TESTING
7.24
7.24
7.24
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
0.001
1
02-01-2023
Week 0
1
27
TOB07
PT
111
Condition 1
27
ENDTXN
Endotoxin
STABILITY TESTING
Toxins
NOT DETECTED
NOT DETECTED
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
28
TOB07
PT
111
Condition 1
28
AEBPLCT
Aerobic Plate Count
STABILITY TESTING
Microbiological
<1
CFU/mL
<1
CFU/mL
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
29
TOB07
PT
111
Condition 1
29
TYMC
Total Yeast and/or Mold Count
STABILITY TESTING
Microbiological
1
CFU/mL
1
1
CFU/mL
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
30
TOB07
PT
111
Condition 1
30
ACTALD
Acetaldehyde
STABILITY TESTING
Aldehyde
7.8
ug/mL
7.8
7.8
ug/mL
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
31
TOB07
PT
111
Condition 1
31
ACTPROPN
Acetyl Propionyl
STABILITY TESTING
Diketone
32.4
ug/mL
32.4
32.4
ug/mL
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
0.001
1
02-01-2023
Week 0
1
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The second PT dataset shows testing for just 1 constituent (nicotine), performed in 3 replicates (note the values of PTREPNUM), at the first 3 time points of the study (as shown in PTTPT/PTTPTNUM), from 3 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.
As in the first PT dataset, the details of the smoking machine and vaping 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/Vaping Regimens.
Details of the 3 conditions are represented in the ES dataset example that follows.
pt.xpt
pt.xpt
Row
STUDYID
DOMAIN
SPTOBID
SPDEVID
STOCONID
PTSEQ
PTREFID
PTTESTCD
PTTEST
PTORRES
PTORRESU
PTSTRESC
PTSTRESN
PTSTRESU
PTNAM
PTXFN
PTSPEC
PTREPNUM
PTDTC
PTTPT
PTTPTNUM
1
TOB07
PT
111
Condition 1
211
NICOTINE
Nicotine
35.94
mg/g
35.94
35.94
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
1
02-01-2023
Week 0
1
2
TOB07
PT
111
Condition 1
212
NICOTINE
Nicotine
35.46
mg/g
35.46
35.46
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
2
02-01-2023
Week 0
1
3
TOB07
PT
111
Condition 1
213
NICOTINE
Nicotine
35.97
mg/g
35.97
35.97
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
3
02-01-2023
Week 0
1
4
TOB07
PT
111
Condition 1
214
NICOTINE
Nicotine
35.55
mg/g
35.55
35.55
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
1
03-29-2023
Week 8
2
5
TOB07
PT
111
Condition 1
215
NICOTINE
Nicotine
35.88
mg/g
35.88
35.88
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
2
03-29-2023
Week 8
2
6
TOB07
PT
111
Condition 1
216
NICOTINE
Nicotine
35.67
mg/g
35.67
35.67
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
3
03-29-2023
Week 8
2
7
TOB07
PT
111
Condition 1
217
NICOTINE
Nicotine
36.11
mg/g
36.11
36.11
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
1
07-19-2023
Week 24
3
8
TOB07
PT
111
Condition 1
218
NICOTINE
Nicotine
35.72
mg/g
35.72
35.72
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
2
07-19-2023
Week 24
3
9
TOB07
PT
111
Condition 1
219
NICOTINE
Nicotine
35.54
mg/g
35.54
35.54
mg/g
TPT LABCO
TLEL01_v1.5.pdf
E-LIQUID
3
07-19-2023
Week 24
3
10
TOB07
PT
111
PUFFMASTER3K
Condition 2
220
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1039
mg/PUFF
0.1039
0.1039
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
1
02-01-2023
Week 0
1
11
TOB07
PT
111
PUFFMASTER3K
Condition 2
221
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1142
mg/PUFF
0.1142
0.1142
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
2
02-01-2023
Week 0
1
12
TOB07
PT
111
PUFFMASTER3K
Condition 2
222
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1282
mg/PUFF
0.1282
0.1282
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
3
02-01-2023
Week 0
1
13
TOB07
PT
111
PUFFMASTER3K
Condition 2
223
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1242
mg/PUFF
0.1242
0.1242
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
1
03-29-2023
Week 8
2
14
TOB07
PT
111
PUFFMASTER3K
Condition 2
224
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1084
mg/PUFF
0.1084
0.1084
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
2
03-29-2023
Week 8
2
15
TOB07
PT
111
PUFFMASTER3K
Condition 2
225
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1174
mg/PUFF
0.1174
0.1174
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
3
03-29-2023
Week 8
2
16
TOB07
PT
111
PUFFMASTER3K
Condition 2
226
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1374
mg/PUFF
0.1374
0.1374
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
1
07-19-2023
Week 24
3
17
TOB07
PT
111
PUFFMASTER3K
Condition 2
227
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1364
mg/PUFF
0.1364
0.1364
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
2
07-19-2023
Week 24
3
18
TOB07
PT
111
PUFFMASTER3K
Condition 2
228
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1264
mg/PUFF
0.1264
0.1264
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
3
07-19-2023
Week 24
3
19
TOB07
PT
111
PUFFMASTER3K
Condition 2
229
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1256
mg/PUFF
0.1256
0.1256
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
1
02-01-2023
Week 0
1
20
TOB07
PT
111
PUFFMASTER3K
Condition 3
230
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1236
mg/PUFF
0.1236
0.1236
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
2
02-01-2023
Week 0
1
21
TOB07
PT
111
PUFFMASTER3K
Condition 3
231
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1126
mg/PUFF
0.1126
0.1126
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
3
02-01-2023
Week 0
1
22
TOB07
PT
111
PUFFMASTER3K
Condition 3
232
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1334
mg/PUFF
0.1334
0.1334
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
1
03-29-2023
Week 8
2
23
TOB07
PT
111
PUFFMASTER3K
Condition 3
233
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1134
mg/PUFF
0.1134
0.1134
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
2
03-29-2023
Week 8
2
24
TOB07
PT
111
PUFFMASTER3K
Condition 3
234
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1125
mg/PUFF
0.1125
0.1125
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
3
03-29-2023
Week 8
2
25
TOB07
PT
111
PUFFMASTER3K
Condition 3
235
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1156
mg/PUFF
0.1156
0.1156
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
1
07-19-2023
Week 24
3
26
TOB07
PT
111
PUFFMASTER3K
Condition 3
236
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1145
mg/PUFF
0.1145
0.1145
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
2
07-19-2023
Week 24
3
27
TOB07
PT
111
PUFFMASTER3K
Condition 3
237
NON-INTENSE REGIMEN
NICOTINE
Nicotine
0.1157
mg/PUFF
0.1157
0.1157
mg/puff
TPT LABCO
TLAE01_v2.1.pdf
AEROSOL
3
07-19-2023
Week 24
3
$warningHtml
Details of the storage conditions are represented in the ES dataset. The variable STOCONID/Storage Condition ID represents the storage condition and links to the PT datasets 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 dataset shows all 3 sets of storage conditions used across both of the PT dataset examples.