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This is a study where subjects were randomized to 3 different concentrations of Nicotine e-liquid, or their usual brand of cigarettes. 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 tobacco products 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/usual brand of cigarettes in the morning and afternoon. Puff topography was measured in the morning and afternoon using the same device for all subjects. Subjects were not allowed to use any tobacco products between the morning and afternoon sessions. 

A  Study Reference domain, DI, was used to identify the device used to measure puff topography. This provides 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 ANALYZER
2TOPT001DIPUFANYXYZ2MODELModelPUFFALYZER 900
3TOPT001DIPUFANYXYZ3MANUFManufacturerACME
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The sponsor submitted the EX TOBA-80 - Getting issue details... STATUS domain t SDTM-715 - Getting issue details... STATUS o represent the usage of the tobacco product. For each subject, the usage for the two week period 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

RowSTUDYIDDOMAINUSUBJIDSPTOBIDEXSEQEXLNKIDEXTRTEXDOSEEXDOSTXTEXDOSUEXDOSFRMEXROUTEEXPSTRGEXPSTRGUEXSTDTCEXENDTC
1TOPT001EX3001EC-3331
Nicotine e-liquid
AD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-06-262020-07-14
2TOPT001EX3001EC-33321Nicotine e-liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-07-15T9:002020-07-15TT9:45
3TOPT001EX3001EC-33332Nicotine e-liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-07-15T3:002020-07-15TT3:45
4TOPT001EX4001EC-3331
Nicotine e-liquid
AD LIBITUM
CARTRIDGERESPIRATORY (INHALATION)16mg/mL2020-09-062020-09-22
5TOPT001EX4001EC-33321Nicotine e-liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)16mg/mL2020-09-22T9:002020-09-22T9:30
6TOPT001EX4001EC-33332Nicotine e-liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)16mg/mL2020-09-22T3:002020-09-22T3:30
7TOPT001EX5004
1
Cigarettes Brand XYZ
AD LIBITUM
CIGARETTERESPIRATORY (INHALATION)12.1mg/cigarette2020-10-082020-10-22
8TOPT001EX5004
21Cigarettes Brand XYZ10
PUFFCIGARETTERESPIRATORY (INHALATION)12.1mg/cigarette2020-10-22T9:002020-09-22T9:30
9TOPT0011EX5004
32Cigarettes Brand XYZ10
PUFFCIGARETTERESPIRATORY (INHALATION)12.1mg/cigarette2020-10-22T3:002020-09-22T3:30
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The FAEX domain was used to represent the puff topography associated with the in-clinic visit. The Findings About Events or Interventions structure (or "FA structure") is used to represent collected data that are findings about” an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. Not all findings associated with an event or intervention should be represented in the FA structure.

A puff-by puff analysis was performed. FATPT was used to represent the time point, in this case, AM and PM. Typically, the sponsor derives summary results using the individual source data records; these summary results are represented in ADaM. However, if summary results are collected on a CRF or provided by an external vendor, these derived results can be represented in FAEX using the variable FACOLSRT. In this example, the sponsor created an ADaM dataset to represent the summary data ( Not Shown). 

Rows 1, 6:Show the Number of Puffs taken in the time interval specified in FADTC and FAENDTC. This was pre-specified in the design, but the sponsor reported the actual number of puffs taken.
Rows 2-5:Show the various measurements recorded for subject 3001 for Puff 1 during the morning administration of the tobacco product. FADTC and FAENDTC provide the timing of each puff. The individual puff data for the afternoon are not shown.
Rows 6-10:Show the various measurements recorded for subject 3001 for Puff 10 during the afternoon administration of the tobacco product. FADTC and FAENDTC provide the timing of each puff. The individual puff data for the morning session are not shown. Note the data for Puffs 2-9 are not shown to simplify dataset review.
Rows 12-15:Show the various measurements recorded for subject 4001. Only a few rows are shown to simplify dataset review.

fa.xpt

faex.xpt

RowSTUDYIDDOMAINUSUBJIDSPDEVIDSPTOBIDFASEQFALNKIDFASPIDFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESUVISITNUMFADTCFAENDTCFATPT
1TOPT001FA3001PUFANYXYZEC-33311
PUFF TOTTotal Number of PuffsNicotine e-liquid

PUFF TOPOGRAPHY

10PUFFS10PUFFS22020-07-15T09:002020-07-15TT9:45

AM

2TOPT001FA3001PUFANYXYZEC-33321PUFF 1PUFFVOLPuff VolumeNicotine e-liquid

PUFF TOPOGRAPHY

36.7mL/sec37mL/sec2

2020-07-15T09:01.36

2020-07-15T09:01.38

AM

3

TOPT001

FA3001PUFANYXYZEC-33331PUFF 1AVGFLOWAverage Flow rateNicotine e-liquidPUFF TOPOGRAPHY15.5mL/sec15.5mL/sec22020-07-15T09:01.362020-07-15T09:01.38AM
4TOPT001FA3001PUFANYXYZEC-33341PUFF 1PKFLOWPeak Flow RateNicotine e-liquidPUFF TOPOGRAPHY20.5mL/sec20.5mL/sec22020-07-15T09:01.362020-07-15T09:01.38AM
5TOPT001FA3001PUFANYXYZEC-33351PUFF 1PUFFDURPuff DurationNicotine e-liquidPUFF TOPOGRAPHY2.0msec1.6msec22020-07-15T09:01.362020-07-15T09:01.38AM
6

TOPT001

FA3001PUFANYXYZEC-33362
PUFF TOTTotal Number of Puffse-nicotin liquid

PUFF TOPOGRAPHY

9PUFFS9PUFFS22020-07-15T03:002020-07-15T03:30PM
7TOPT001FA3001PUFANYXYZEC-33372PUFF 10INTPUFINPuff IntervalNicotine e-liquidPUFF TOPOGRAPHY910396.8sec910396.8sec22020-07-15T03:30:342020-07-15T03:30:36PM
8TOPT001FA3001PUFANYXYZEC-33382PUFF 10PUFFVOLPuff VolumeNicotine e-liquidPUFF TOPOGRAPHY43mL/sec43mL/sec22020-07-15T03:30:342020-07-15T03:30:36

PM

9

TOPT001

FA3001PUFANYXYZEC-33392PUFF 10AVGFLOWAverage Flow rateNicotine e-liquidPUFF TOPOGRAPHY14.5mL/sec14.5mL/sec22020-07-15T03:30:342020-07-15T03:30:36

PM

10TOPT001FA3001PUFANYXYZEC-333102PUFF 10PKFLOWPeak Flow RateNicotine e-liquidPUFF TOPOGRAPHY22.5mL/sec22.5mL/sec22020-07-15T03:30:342020-07-15T03:30:36

PM

12TOPT001FA4001PUFANYXYZEC-33311
PUFF TOTTotal Number of PuffsNicotine e-liquid

PUFF TOPOGRAPHY

10PUFFS10PUFFS22020-08-15T9:002020-08-15TT9:45

AM

13

TOPT001

FA4001PUFANYXYZEC-33321PUFF 1PUFFVOLPuff VolumeNicotine e-liquidPUFF TOPOGRAPHY34.7mL/sec34mL/sec22020-08-15T09:01.362020-08-15T09:01.38AM
14TOPT001FA4001PUFANYXYZEC-33331PUFF 1AVGFLOWAverage Flow rateNicotine e-liquidPUFF TOPOGRAPHY15.5mL/sec15.5mL/sec22020-08-15T09:01.362020-08-15T09:01.38AM
15TOPT001FA4001PUFANYXYZEC-33341PUFF 1PKFLOWPeak Flow RateNicotine e-liquidPUFF TOPOGRAPHY23.5mL/sec23.5mL/sec22020-08-15T09:01.362020-08-15T09:01.38AM
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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.
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relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1TD23EX
EXLNKID
ONEEXFA1
2TD23FAEX
FALNKID
MANYEXFA1
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