The following example illustrates stability study results for an ENDS tobacco product
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-107 |
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. Stability study results are represented in the PT domain, with PTCAT = STABILITY STUDY.
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-156 |
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The first pt.xpt dataset shows 22 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. |
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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. |
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Dataset2 |
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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 |
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1 | TOB07 | PT | 111 |
| Condition 1 | | | NICOTINE | Nicotine | STABILITY STUDY |
| 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 |
| | 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 | 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 | 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 | 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 | 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 | 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 STUDY | 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 | 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 | 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 | 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 | Stabilizer | NOT DETECTED |
| 0.00011 | NOT DETECTED |
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| 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 |
| 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 |
| DETECTED, BELOW LLOQ |
| 0.00928 | DETECTED, BELOW LLOQ |
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| 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 |
| 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 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 |
| NOT DETECTED |
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| NOT DETECTED |
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| 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 | pHjira showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-109 |
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| | STABILITY STUDY |
| 7.15 |
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| 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 |
| 7.24 |
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| 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 | Toxins | NOT DETECTED |
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| NOT DETECTED |
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| 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 STUDY | 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 STUDY | 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 STUDY | 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 | 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 |
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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 Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-124 |
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| ), 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. |
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