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The following example illustrates calculation of some of the statistics typically calculated on product stability measures.

Variable NameVariable LabelTypeCodelist/Controlled TermsCoreCDISC Notes

STUDYID

Study IdentifierChar
ReqPT.STUDYID
USUBJIDUnique Subject IdentifierChar
ReqN/A
TRTPPlanned TreatmentChar
CondN/A
TRTAActual TreatmentChar
CondN/A
PARQUAL




PARAMParameterChar
Req
PARAMCDParameter Codetext
Req
PARCAT1Parameter Category 1Char
PermPT.PTCAT
AVALAnalysis ValueNum
Condsee parameter level metadata
PTSEQSequence NumberNum
PermPT.PTSEQ

ADPT

STUDYIDSPTOBID
PTREFIDPARQUALPARAMPARAMCDAVALPTTSTCNDPTSEQ
TOB07Smokeless01
TOB77777.1Product Moisture (%)AverageAVERAGE
Condition 1 (X°C/ Z% RH)1
TOB07Smokeless01
TOB77777.1Product Moisture (%)S.D.STD
Condition 1 (X°C/ Z% RH)1
TOB07Smokeless01
TOB77777.1Product Moisture (%)% RSDPCTRSD
Condition 1 (X°C/ Z% RH)1
TOB07Smokeless01
TOB77777.1pHAverageAVERAGE
Condition 1 (X°C/ Z% RH)2
TOB07Smokeless01
TOB77777.1pHS.D.STD
Condition 1 (X°C/ Z% RH)2
TOB07Smokeless01
TOB77777.1pH% RSDPCTRSD
Condition 1 (X°C/ Z% RH)2
TOB07Smokeless01
TOB77777.1Water ActivityAverageAVERAGE
Condition 1 (X°C/ Z% RH)3
TOB07Smokeless01
TOB77777.1Water ActivityS.D.STD
Condition 1 (X°C/ Z% RH)3
TOB07Smokeless01
TOB77777.1Water Activity% RSDPCTRSD
Condition 1 (X°C/ Z% RH)3
TOB07Smokeless01
TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESHAverageAVERAGE
Condition 1 (X°C/ Z% RH)4
TOB07Smokeless01
TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESHS.D.STD
Condition 1 (X°C/ Z% RH)4
TOB07Smokeless01
TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - FRESH% RSDPCTRSD
Condition 1 (X°C/ Z% RH)4
TOB07Smokeless01
TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIEDAverageAVERAGE
Condition 1 (X°C/ Z% RH)5
TOB07Smokeless01
TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIEDS.D.STD
Condition 1 (X°C/ Z% RH)5
TOB07Smokeless01
TOB77777.14-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) (ng/g) - DRIED% RSDPCTRSD
Condition 1 (X°C/ Z% RH)5
TOB07Smokeless01
TOB77777.1N-nitrosonornicotine) (ng/g) - FRESHAverageAVERAGE
Condition 1 (X°C/ Z% RH)6
TOB07Smokeless01
TOB77777.1N-nitrosonornicotine) (ng/g) - FRESHS.D.STD
Condition 1 (X°C/ Z% RH)6
TOB07Smokeless01
TOB77777.1N-nitrosonornicotine) (ng/g) - FRESH% RSDPCTRSD
Condition 1 (X°C/ Z% RH)6
TOB07Smokeless01
TOB77777.1N-nitrosonornicotine (ng/g) - DRIEDAverageAVERAGE
Condition 1 (X°C/ Z% RH)7
TOB07Smokeless01
TOB77777.1N-nitrosonornicotine (ng/g) - DRIEDS.D.STD
Condition 1 (X°C/ Z% RH)7
TOB07Smokeless01
TOB77777.1N-nitrosonornicotine (ng/g) - DRIED% RSDPCTRSD
Condition 1 (X°C/ Z% RH)7
TOB07Smokeless01
TOB77777.1Tobacco-specific nitrosamines (ng/g) - FRESHAverageAVERAGE
Condition 1 (X°C/ Z% RH)8
TOB07Smokeless01
TOB77777.1Tobacco-specific nitrosamines (ng/g) - FRESHS.D.STD
Condition 1 (X°C/ Z% RH)8
TOB07Smokeless01
TOB77777.1Tobacco-specific nitrosamines (ng/g) - FRESH% RSDPCTRSD
Condition 1 (X°C/ Z% RH)8
TOB07Smokeless01
TOB77777.1Tobacco-specific nitrosamines (ng/g) - DRIEDAverageAVERAGE
Condition 1 (X°C/ Z% RH)9
TOB07Smokeless01
TOB77777.1Tobacco-specific nitrosamines (ng/g) - DRIEDS.D.STD
Condition 1 (X°C/ Z% RH)9
TOB07Smokeless01
TOB77777.1Tobacco-specific nitrosamines (ng/g) - DRIED% RSDPCTRSD
Condition 1 (X°C/ Z% RH)9
TOB07Smokeless01
TOB77777.1Aerobic Plate CountAverageAVERAGE
Condition 1 (X°C/ Z% RH)10
TOB07Smokeless01
TOB77777.1Aerobic Plate CountS.D.STD
Condition 1 (X°C/ Z% RH)10
TOB07Smokeless01
TOB77777.1Aerobic Plate Count% RSDPCTRSD
Condition 1 (X°C/ Z% RH)10
TOB07Smokeless01
TOB77777.1MoldAverageAVERAGE
Condition 1 (X°C/ Z% RH)11
TOB07Smokeless01
TOB77777.1MoldS.D.STD
Condition 1 (X°C/ Z% RH)11
TOB07Smokeless01
TOB77777.1Mold% RSDPCTRSD
Condition 1 (X°C/ Z% RH)11
TOB07Smokeless01
TOB77777.1YeastAverageAVERAGE
Condition 1 (X°C/ Z% RH)12
TOB07Smokeless01
TOB77777.1YeastS.D.STD
Condition 1 (X°C/ Z% RH)12
TOB07Smokeless01
TOB77777.1Yeast% RSDPCTRSD
Condition 1 (X°C/ Z% RH)12
param1paramval1param2paramval2colvar1colvar2colvaltypcolvalcolvalucolord

shelf life factor

Product Moisture 

statistic

AverageCondition 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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