The following example illustrates calculation of some of the statistics typically calculated on product stability measures.
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | Char | Req | PT.STUDYID | |
| USUBJID | Unique Subject Identifier | Char | Req | N/A | |
| TRTP | Planned Treatment | Char | Cond | N/A | |
| TRTA | Actual Treatment | Char | Cond | N/A | |
| PARQUAL | |||||
| PARAM | Parameter | Char | Req | ||
| PARAMCD | Parameter Code | text | Req | ||
| PARCAT1 | Parameter Category 1 | Char | Perm | PT.PTCAT | |
| AVAL | Analysis Value | Num | Cond | see parameter level metadata | |
| PTSEQ | Sequence Number | Num | Perm | PT.PTSEQ |
ADPT
| STUDYID | SPTOBID | PTREFID | PARQUAL | PARAM | PARAMCD | AVAL | PTTSTCND | PTSEQ | |
|---|---|---|---|---|---|---|---|---|---|
| TOB07 | Smokeless01 | TOB77777.1 | Product Moisture (%) | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 1 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Product Moisture (%) | S.D. | STD | Condition 1 (X°C/ Z% RH) | 1 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Product Moisture (%) | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 1 | ||
| TOB07 | Smokeless01 | TOB77777.1 | pH | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 2 | ||
| TOB07 | Smokeless01 | TOB77777.1 | pH | S.D. | STD | Condition 1 (X°C/ Z% RH) | 2 | ||
| TOB07 | Smokeless01 | TOB77777.1 | pH | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 2 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Water Activity | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 3 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Water Activity | S.D. | STD | Condition 1 (X°C/ Z% RH) | 3 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Water Activity | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 3 | ||
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESH | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 4 | ||
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESH | S.D. | STD | Condition 1 (X°C/ Z% RH) | 4 | ||
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESH | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 4 | ||
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIED | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 5 | ||
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIED | S.D. | STD | Condition 1 (X°C/ Z% RH) | 5 | ||
| TOB07 | Smokeless01 | TOB77777.1 | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIED | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 5 | ||
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine) (ng/g) - FRESH | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 6 | ||
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine) (ng/g) - FRESH | S.D. | STD | Condition 1 (X°C/ Z% RH) | 6 | ||
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine) (ng/g) - FRESH | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 6 | ||
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine (ng/g) - DRIED | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 7 | ||
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine (ng/g) - DRIED | S.D. | STD | Condition 1 (X°C/ Z% RH) | 7 | ||
| TOB07 | Smokeless01 | TOB77777.1 | N-nitrosonornicotine (ng/g) - DRIED | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 7 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - FRESH | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 8 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - FRESH | S.D. | STD | Condition 1 (X°C/ Z% RH) | 8 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - FRESH | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 8 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - DRIED | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 9 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - DRIED | S.D. | STD | Condition 1 (X°C/ Z% RH) | 9 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Tobacco-specific nitrosamines (ng/g) - DRIED | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 9 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Aerobic Plate Count | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 10 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Aerobic Plate Count | S.D. | STD | Condition 1 (X°C/ Z% RH) | 10 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Aerobic Plate Count | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 10 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Mold | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 11 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Mold | S.D. | STD | Condition 1 (X°C/ Z% RH) | 11 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Mold | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 11 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Yeast | Average | AVERAGE | Condition 1 (X°C/ Z% RH) | 12 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Yeast | S.D. | STD | Condition 1 (X°C/ Z% RH) | 12 | ||
| TOB07 | Smokeless01 | TOB77777.1 | Yeast | % RSD | PCTRSD | Condition 1 (X°C/ Z% RH) | 12 |
| param1 | paramval1 | param2 | paramval2 | colvar1 | colvar2 | colvaltyp | colval | colvalu | colord |
shelf life factor | Product Moisture | statistic | Average | Condition 1 (X°C/ Z% RH) | Week 0 | text? | xxx.x | % | 1 |
shelf life factor | Product Moisture | statistic | S.D. | Condition 1 (X°C/ Z% RH) | Week 0 | xxx.xx | % | 1 | |
shelf life factor | Product Moisture | statistic | % RSD | Condition 1 (X°C/ Z% RH) | Week 0 | xxx.x | % | 1 | |
shelf life factor | Product Moisture | statistic | Average | Condition 2 (A °C/ B %RH) | Week 0 | xxx.x | % | 10 | |
shelf life factor | Product Moisture | statistic | S.D. | Condition 2 (A °C/ B %RH) | Week 0 | xxx.xx | % | 10 | |
shelf life factor | Product Moisture | statistic | % RSD | Condition 2 (A °C/ B %RH) | Week 0 | xxx.x | % | 10 |
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