The following example illustrates stability study results for an ENDS tobacco product
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-107 |
|---|
|
. Stability study results are represented in the
Tobacco Product Testing (PT
) domain, with PTCAT = STABILITY
STUDYTESTING.
| Info |
|---|
The first pt.xpt dataset shows 22 constituents consituents and parameters each as a single replicate (PTREPNUM=1), at one 1 time point (PTTPT=Week 0 / PTTPTNUM=1) and from one 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 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 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 smoking vaping 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 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 ES Environmental Storage Conditions (ES) dataset example that follows the two 2 PT dataset examples.
- In this example, the applicant chose to sub-categorize some constituents subcategorize some consituents and parameters using the permissible variable PTSCAT (Sub-Category of Test).
|
| Dataset wrap |
|---|
|
| 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 |
|---|
| 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 | | | NICOTINE | Nicotine | STABILITY |
STUDY| 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 |
STUDY| TESTING |
| | 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 | | STABILITY |
STUDY| 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 | | STABILITY |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| TESTING | Primary Ingredient | 218.21 | mg/g |
| 218.21 | 218.21 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 |
Week | 02-01-2023 | Week 0 | 1 | | 8 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 8 | NON-INTENSE REGIMEN | PRPYLGLY | Propylene Glycol | STABILITY |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 |
STUDY| 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 | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-109 |
|---|
|
| STABILITY STUDY |
| 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 |
STUDY| 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 |
STUDY| 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 Plate STUDY| 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 |
TYMCTotal | Yeast and/or Mold Colony Count | STABILITY |
STUDY| TESTING | Microbiological | 1 | CFU/mL |
| 1 | 1 | CFU/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 |
1 | 1 | 02-01-2023 | Week 0 | 1 | | 30 | TOB07 | PT | 111 |
| Condition 1 | 30 |
| ACTALD | Acetaldehyde | STABILITY |
STUDY| 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 |
STUDY| 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.xpt PT dataset shows testing for just one 1 constituent , (nicotine), performed in three 3 replicates (note the values of PTREPNUM), at the first three 3 time points of the study (as shown in PTTPT/PTTPTNUM), from three 3 sets of storage conditions (STOCONID| Jira |
|---|
|
| showSummary | false |
|---|
server | Issue Tracker (JIRA)| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-124 |
|---|
), 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.xpt PT dataset, the details of the smoking machine and smoking vaping 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 2, HPHCs, Other Constituents, and Smoking/Vaping Regimens.
- Details of the three 3 conditions are represented in the ES dataset example that follows below.
|
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | | 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 | | 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 | 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 | -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 | | 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 | | 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 |
|
|
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 ES dataset below shows all three 3 sets of storage conditions used across both pt.xpt of the PT dataset examples above.
| 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 |
|
|