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This is a study were subjects were randomized to use 3 different concentration of e-nicotine liquid. The subject used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After two weeks, the subjects were confined to the clinical for one day. They were required to not use any  e-cigarettes for 12 hours prior to the visit. Subjects had to have CO level below a pre-specified level, to attend the visit.  If the level, was too high, the visit was re-scheduled. Subjects were instructed to take 10 puffs on the e-cigarette. Puff topography was measured using the same device for all subjects. 

A  Study Reference domain, DI, was used to identify the device used to measure puff topography.  The provide a consistent sponsor-defined variable (SPDEVID) for linking data. Device identifiers exist independently from subjects; therefore, the DI domain does not contain USUBJID. Only one device was used for all subjects in the study. 

di.xpt

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOPT001DIPUFANYXYZ1DEVTYPEDevice TypePuff Topography 

Dataset Debug Message

There is a leading, trailing, or non-breaking space in the dataset.

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.    

   

ex.xpt

ex.xpt

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
$warningHtml
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.    
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.

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

fa.xpt

faex.xpt

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

Dataset Debug Messages

  • There are seven leading, trailing, or non-breaking spaces in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

FA NSV Metadata

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The RELREC dataset was used to record the relationship between the Exposure records in EX and the records in FAEX.


$titleHtml

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1TD23CM
EXSPID
ONEEXFA1
2TD23FACM
FASPID
MANYEXFA1
$warningHtml

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