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.
| Info |
|---|
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. |
| 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 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).
|
| Warning |
|---|
THIS EXAMPLE IS UNDER RE-CONSTRUCTION FOLLOWING THE TEAM CALL ON 17 JAN. See also example in the "sandbox' here, which demonstrates the current approach reviewed on that call. |
| Info |
|---|
NOTE TO TEAM REVIEWERS: The example below demonstrates the required data structure of one record per analyte per replicate per test condition per timepoint to accurately represent data from a stability study.
The resulting structure would require 648 rows to illustrate the 12 analytes shown in the example study we received, done in triplicate under two test conditions at the number of timepoints in the example study. For conciseness, we have abbreviated the examples below to demonstrate the concepts as follows: First- we show all 12 analytes as a single replicate, at one time point and one test condition in order to illustrate the variables and terminology required to put together a stability study with assays done in replicate at different time points and varying test conditions, even though only one record per analyte is illustrated. Second- We show ONE analyte (moisture) in triplicate, over a series of time points and two test conditions to give a sense of what the complete data would look like. Hopefully users could combine the information shown in both examples to construct a complete dataset containing all the records for each analyte-replicate-test condition-time point group. |
The example shown below is not an all inclusive comprehensive example. It is meant to be illustrative of the concepts.
Shelf life study has a protocol and provides the results of shelf life studies of Vapes products over time with different conditions and analytes. Generally there are many conditions with at least two with varying temperature, humidity, etc. The initial table shows the a number of the analytes and test conditions used in Shelf Life studies for Vapes products for one testing condition at one timepoint and one replicate.
Tobacco Product Testing (PT) is a Findings domain similar to the Laboratory Test Results domain.
PTCAS variable (in place of the LBLOINC variable) provides the accurate chemical name, structure for organic and inorganic substances.
| dataset-wrap |
|---|
|
| Rowcaps |
|---|
-20:| Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is Condition 1. | | Rows 2, 12, 13: | Show the Nicotine, 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK), and N-nitrosonornicotine analytes in the Aerosol substance represented using the PTSPEC variable. | Rows 17, 18: | Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is Condition 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 |
|---|
| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | STOCONDID | PTSEQ | PTREFID |
|---|
PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU |
|---|
PTSPECPTSPCCNDPTMETHOD| PTSPEC | PTLLOQ | PTREPNUM | PTDTC | PTTPT | PTTPTNUM |
|---|
| 1 | TOB07 | PT | 111 |
| Condition 1 | |
VAP77777.1 | 54-11-5 | NICOTINE | Nicotine | | NICOTINE | Nicotine | STABILITY TESTING |
| 35.94 | mg/g |
| 35.94 | 35.94 | mg/g | TPT LABCO | TLEL01_v1.5.pdf |
STABILITY STUDY | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | | 2 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 2 |
VAP77777.1 | 54-11-5 | | NON-INTENSE REGIMEN | NICOTINE | Nicotine | STABILITY |
STUDYAEROSOL | | TESTING |
| | mg/PUFF |
| 0.1039 | 0.1039 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 |
1 | Week 0 | 1 | | 3 | TOB07 | PT | 111 |
| Condition |
13 | VAP77777.494-97- STUDY| TESTING | Nicotine Degradant |
E-LIQUID | | 25.76 | ug/g |
| 25.76 | 25.76 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 |
1 | Week 0 | 1 | | 4 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 4 |
VAP77777.1 | 494-52-0 | ANABASN | | STABILITY STUDY | Nicotine Degradant | E-LIQUID | | NON-INTENSE REGIMEN | NORNCTN | | 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 |
1 | Week 0 | 1 | | 5 | TOB07 | PT | 111 |
| Condition |
15 | VAP77777.56-81- STUDY| TESTING | Primary Ingredient |
E-LIQUID | 1 | Week 0 | 1 | | 615.68 | mg/g |
| 615.68 | 615.68 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 |
6 | TOB07 | PT | 111 | Condition 1 | 6 | VAP77777.1 | 57-55-6 | PRPYLGLY | Propylene Glycol | STABILITY STUDY | Primary Ingredient | E-LIQUID | 17| 6 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
7 | VAP77777.1 | 65-85-0 | XXXXX | Benzoic Acid | STABILITY STUDY | Acid | E-LIQUID | 1 | Week 0 | 1 | 8 | TOB07 | PT | 111 | Condition 1 | 8 | VAP77777.1 | 89-78-1 confirm this one, there are two - the other is 1490-04-6 | 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 |
XXXXX | Menthol | STABILITY STUDY | Flavorant | E-LIQUID | 199VAP77777.1 | XXXXX | Vanillin STUDYFlavorant | E-LIQUID | | 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 |
110| 8 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
10 | VAP77777.1 | 64091-91-4 | NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY STUDY | HPHC | E-LIQUID | | 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 |
11111 | VAP77777.1 | 80508-23-2 | NNN | N-Nitrosonornicotine | STABILITY STUDY | HPHC | E-LIQUID | | 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 |
11212VAP77777.1 | 64091-91-4 | NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY STUDY | HPHC | AEROSOL |
| 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 |
113| 11 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
13 | VAP77777.1 | 80508-23-2 | NNN | N-Nitrosonornicotine | STABILITY STUDY | HPHC | AEROSOL | 1 | Week 0 | 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 |
14 | TOB07 | PT | 111 | Condition 1 | 14 | VAP77777.1 | NICKEL | Nickel | STABILITY STUDY | Extractables / Leachables | E-LIQUID | 115| 12 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
15 | VAP77777.1 | PH | pH | STABILITY STUDY | E-LIQUID | 1 | Week 0 | 1 | 16 | TOB07 | PT | 111 | Condition 1 | 16 | VAP77777.1 | XXXXX | Endotoxin | STABILITY STUDY | Toxins | E-LIQUID | | 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 |
117| 13 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
17 | VAP77777.1 | AEBPLCT | Aerobic Plate Count | STABILITY STUDY | Microbiological | E-LIQUID | 1 | Week 0 | 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 |
18 | TOB07 | PT | 111 | Condition 1 | 18 | VAP77777.1 | TYMC | Total Yeast and/or Mold Count | STABILITY STUDY | Microbiological | E-LIQUID | 119| 14 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 |
19 | VAP77777.1 | 75-07-0 | ACTALD | Acetaldehyde | STABILITY STUDY | Aldehyde | E-LIQUID | | 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 |
12020VAP77777.1 | ACTPROPN | Acetyl propionyl | STABILITY STUDY |
| LACTICAC | Lactic Acid | STABILITY TESTING |
| 40.44 | ug/g |
| 40.44 | 40.44 | ug/g | TPT LABCO | TLEL01_v1.5.pdf |
Diketone | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
|
|
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 portions of the content using the TEST of Nicotine 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. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/puff is valid.
| | 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 | | 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 |
| AEBCT | Aerobic Colony 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 |
| YSTMLDCT | Yeast and/or Mold Colony 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 |
|
|
| Info |
|---|
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. |
| Note |
|---|
- 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.
|
| Dataset wrap |
|---|
|
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-9: | Show the PTTEST of Nicotine for Condition 1 which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine 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 10-19: | Show the PTTEST of Nicotine for Condition 2 across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain. |
Rows 20-27: | Show the PTTEST of Nicotine for Condition 3 across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain. | | Dataset2 |
|---|
| Row | | DOMAIN | SPTOBID | SPDEVID | STOCONID | PTSEQ | PTREFIDPTGRPID | PTTESTCD | PTTEST | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPECPTNAM | PTSPCCNDPTXFN | PTMETHODPTSPEC | PTREPNUM | PTDTC | PTTPT | PTTPTNUM |
|---|
| 1 | TOB07 | PT | 111 |
| Condition 1 | 211 | VAP77777.1 | 1 |
| NICOTINE | | 35.94 | mg/mLg | 35.94 | 35.94 | mg/mLg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | 02-01-2023 | Week 0 | 1 | | 2 | TOB07 | PT | 111 |
| Condition 1 | 212 | VAP77777.1 | 1 | | | Nicotine | 35.46 | mg/mLg | 35.46 | 35.46 | mg/mLg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | 02-01-2023 | Week 0 | 1 | | 3 | TOB07 | PT | 111 |
| Condition 1 | 213 |
| NICOTINE | Nicotine | VAP7777735. | 197 | 1 | NICOTINE | mg/g | 35.97 | 35.97Nicotine | mg/mLmg/mLg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | 02-01-2023 | Week 0 | 1 | | 4 | TOB07 | PT | 111 |
| Condition 1 | 214 | VAP77777.1 | 1 |
| NICOTINE | Nicotine | 35.55 | mg/mLg | 35.55 | 35.55 | mg/mLg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | 03-29-2023 | Week 248 | 42 | | 5 | TOB07 | PT | 111 |
| Condition 1 | 215 |
| NICOTINE | Nicotine | VAP7777735. | 188 | 1 | NICOTINE | mg/g | 35.88 | 35.88Nicotine | mg/mLmg/mLg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | 03-29-2023 | Week 248 | 42 | | 6 | TOB07 | PT | 111 |
| Condition 1 | 216 |
| NICOTINE | Nicotine | VAP7777735. | 167 | 1 | NICOTINE | mg/g | 35.67 | 35.67Nicotine | mg/mLmg/mLg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | 03-29-2023 | Week 248 | 42 | | 7 | TOB07 | PT | 111 |
| Condition 1 | 217 | VAP77777.1 | 1 |
| NICOTINE | Nicotine | 36.11 | mg/mLg | 36.11 | 36.11 | mg/mLg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | 07-19-2023 | Week 5224 | 93 | | 8 | TOB07 | PT | 111 | Condition 1 | 218 | VAP77777. |
| Condition 11 | 218 |
| NICOTINE | Nicotine | 35.72 | mg/mLg | 35.72 | 35.72 | mg/mLg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | 07-19-2023 | Week 5224 | 93 | | 9 | TOB07 | PT | 111 |
| Condition 1 | 219 |
| NICOTINE | Nicotine | VAP7777735. | 154 | 1 | NICOTINE | mg/g | 35.54 | 35.54Nicotine | mg/mLmg/mLg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | 07-19-2023 | Week 5224 | 93 | | 10 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 220 | VAP77777.1 | 3NON-INTENSE REGIMEN | NICOTINE | | 0.1039 | mg/puffPUFF | 0.1039 | 0.1039 | mg/puff | AEROSOL | | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 02-01-20231 | Week 0 | 1 | | 11 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 221 | VAP77777.1 | 3NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1142 | mg/puffPUFF | 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 | VAP77777.1 | 3 | NICOTINE | | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1282 | mg/PUFF | 0.1282 | 0.1282Nicotine | mg/puffmg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 02-01-2023 | Week 0 | 1 | | 13 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 223 | VAP77777.1 | 3NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1242 | mg/puffPUFF | 0.1242 | 0.1242 | mg/puffpuff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 03-29-2023 | Week 248 | 42 | | 14 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 224 | VAP77777.1 | 3NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1084 | mg/puffPUFF | 0.1084 | 0.1084 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 03-29-2023 | Week 248 | 42 | | 15 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2225 | VAP77777.1 | 225 | NON-INTENSE REGIMEN3 | NICOTINE | Nicotine | 0.1174 | mg/puffPUFF | 0.1174 | 0.1174 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 03-29-2023 | Week 248 | 42 | | 16 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 226 | VAP77777.1 | 3 | NICOTINE | | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1374 | mg/PUFF | 0.1374 | 0.1374Nicotine | mg/puffmg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 07-19-2023 | Week 5224 | 93 | | 17 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 227 | VAP77777.1 | 3NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1364 | mg/puffPUFF | 0.1364 | 0.1364 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 07-19-2023 | Week 5224 | 93 | | 18 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 228 | VAP77777.1 | 3NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1264 | mg/puffPUFF | 0.1264 | 0.1264 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 07-19-2023 | Week 5224 | 93 | | 19 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 229 | VAP77777.1 | 3NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1256 | mg/puffPUFF | 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 | VAP77777.1 | 4 | NICOTINE | | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1236 | mg/PUFF | 0.1236 | 0.1236Nicotine | mg/puffmg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 02-01-2023 | Week 0 | 1 | | 21 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 231 | VAP77777.1 | 4NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1126 | mg/puffPUFF | 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 3232 | VAP77777.1 | 232 | NON-INTENSE REGIMEN4 | NICOTINE | Nicotine | 0.1334 | mg/puffPUFF | 0.1334 | 0.1334 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 03-29-2023 | Week 248 | 42 | | 23 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 233 | VAP77777.1 | 4 | NICOTINE | | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1134 | mg/PUFF | 0.1134 | 0.1134Nicotine | mg/puffmg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 03-29-2023 | Week 248 | 42 | | 24 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 234 | VAP77777.1 | 4NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1125 | mg/puffPUFF | 0.1125 | 0.1125 | mg/puffpuff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 03-29-2023 | Week 248 | 42 | | 25 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 235 | VAP77777.1 | 4NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1156 | mg/puffPUFF | 0.1156 | 0.1156 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 07-19-2023 | Week 5224 | 93 | | 26 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3236 | VAP77777.1 | 236 | NON-INTENSE REGIMEN4 | NICOTINE | Nicotine | 0.1145 | mg/puffPUFF | 0.1145 | 0.1145 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 07-19-2023 | Week 5224 | 93 | | 27 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 237 | VAP77777.1 | 4 | NICOTINE | | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1157 | mg/PUFF | 0.1157 | 0.1157Nicotine | mg/puffmg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 07-19-2023 | Week 5224 | 93 |
|
|
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 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.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | STOCONID | ESSEQ | ESPARMCD | ESPARM | ESVAL | ESVALU |
|---|
| 1 | TOB07 | ES | Condition 1 | 1 | HUMID | Humidity | 37 | % | | 2 | TOB07 | ES | Condition 1 | 2 | TEMP | Temperature | 24 | C | | 3 | TOB07 | ES | Condition 2 | 1 | HUMID | Humidity | 60 | % | | 4 | TOB07 | ES | Condition 2 | 2 | TEMP | Temperature | 27 | C | | 5 | TOB07 | ES | Condition 3 | 1 | HUMID | Humidity | 95 | % | | 6 | TOB07 | ES | Condition 3 | 2 | TEMP | Temperature | 31 | C |
|
|