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The sponsor submitted the EX domain to represent the usage of the e-cigarettes. For each subject, the usage for the two weeks are represented, and then the specified usage during the in-clinic visit are shown. The sponsor elected not to represent each puff in this EX dataset. Each Puff could have been recorded.    

    DEVTYP= PUFF TOPOGRAPHER MODEL= Puffalyzer 900 MANUF = ACME

Dataset wrap
Nameex
Dataset2
RowSTUDYIDDOMAINUSUBJIDEXSEQSPTOBIDEXSPIDEXTRTEXDOSEEXDOSUEXROUTEEXPSTRGEXPSTRGUEXSTDTCEXENDTC
1TOPT001EX30011EC-333
e-nicotine liquidAD LIBITUM
INHALED8mg/mL2020-06-262020-07-14
2TENDS01EX30012EC-333PUFF 1e-nicotine liquid10PUFFSINHALED8mg/mL2020-07-15T9:002020-07-15TT9:45
3TENDS01EX40013EC-333
e-nicotine liquidAD LIBITUM
INHALED16mg/mL2020-09-062020-09-22
3TENDS01EX40014EC-333PUFF 1e-nicotine liquid10PUFFSINHALED16mg/mL2020-09-22T9:002020-09-22T9:30

The FAEX domain was used to represent the puff topography associated with the in -clinic visit.  A puff -by puff analysis was performed. Additionally , the vendor provided the mean puff volume and the mean puff duration for the 10 puffs in the session.    


inter-puff interval: sec average flow-rate (mL/s) peak flow rate (mL/s)


Dataset wrap
Namefaex
Rowcaps
Row 1:Shows the Number of Puff taken in the interval. This was pre-specified in the design, but the sponsor reported the actual number of puffs taken.  
Rows 2-3, 5-6 :Show the puff volume for Subject 3001 for each puff and the puff duration for Subject 4001.  FADTC and FAENDTC provides the timing of each puff. Only data for 2 puffs are shown.  
Rows 4 & 7:  Shows the mean puff volume for Subject 3001 and the mean puff duration for Subject 4001for all puffs during the interval provided in FADTC and FAENDTC. The NSV variable FACOLSRT indicates that the Mean puff volume is provided. The method to calculate the mean was provided in FAMETHOD, in this situation the DEVICE ALGORITHM. 
Dataset2
RowSTUDYIDDOMAINUSUBJIDSPDEVIDFASEQFASPIDFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESUFALOBXFLFAMETHODVISITNUMFADTCFAENDTCFATPT
FACOLSRT
1TGI400FA3001PUFANYXYZ1
PUFF TOTTOTAL NUMBER OF PUFFS e-nicotine liquid


10PUFFS10PUFFS

22020-07-15T9:002020-07-15TT9:45




1TGI400FA3001PUFANYXYZ2PUFF 1PUFFVOL PUFF VOLUMEe-nicotine liquid

PUFF TOPOGRAPHY

66.7ml/sec98ml/sec

2

2020-07-15T9:00


PUFF 1



2

TGI400

FA3001PUFANYXYZ3PUFF 2 PUFFVOL PUFF VOLUME e-nicotine liquidPUFF TOPOGRAPHY43ml/sec43ml/sec

22020-07-15T9:11
PUFF 2

3

TGI400

FA3001PUFANYXYZ4
PUFFVOLPUFF VOLUMEe-nicotine liquidPUFF TOPOGRAPHY53.7ml/sec53.7ml/sec
DEVICE ALGORITHM22020-07-15T9:002020-07-15TT9:45

MEAN
4

TGI400

FA4001PUFANYXYZ1PUFF 1PUFFDURPUFF DURATIONe-nicotine liquidPUFF TOPOGRAPHY2sec2sec

22020-07-22
PUFF 1

5

TGI400

FA4001PUFANYXYZ2PUFF 2 PUFFDURPUFF DURATIONe-nicotine liquidPUFF TOPOGRAPHY1.8sec1.8sec

22020-07-22
PUFF 2 

6

TGI400

FA4001PUFANYXYZ3
PUFFDURPUFF DURATIONe-nicotine liquidPUFF TOPOGRAPHY1.8sec1.8sec
DEVICE ALGORITHM22020-09-22T9:132020-09-22T9:30

MEAN



Nsvmeta
DomainFA
VariableLabelTypeRoleCODELISTOrigin
FACOLSRTCollected Summary Result TypetextNon-standard Record Qualifier(COLSTYP)CRF

...

Dataset wrap
Namerelrec
Dataset2

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1TD23CMEX
EXSPID
ONEEXFA1
2TD23FACMFAEX
FASPID
MANYEXFA1