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This is a study were where subjects were randomized to use 3 different concentration concentrations of nicotine e-nicotine liquid, or their usual brand of cigarettes. The subject subjects used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After two 2 weeks, the subjects were confined to the clinical clinic for one 1 day. They were required to not use any  e-cigarettes any tobacco products for 12 hours prior to the visit. Subjects had to have CO level levels below a pre-specified prespecified level , to attend the visit.   If the level , was too high, the visit was re-scheduledrescheduled. 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. 

Device Identifiers (DI), a Study Reference domain, DI, was used to identify the device used to measure puff topography.   The provide This provides a consistent sponsor-defined variable (SPDEVID) for linking data. Device Because device identifiers exist independently from subjects; therefore, the DI domain does not contain USUBJID. Only one 1 device was used for all subjects in the study. 

Dataset wrap
Namedi
Dataset2
RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOPT001DIPUFANYXYZ1DEVTYPEDevice TypePUFF TOPOGRAPHER TOPOGRAPHY ANALYZER
2TOPT001DIPUFANYXYZ2MODELModelPUFFALYZER 900
3TOPT001DIPUFANYXYZ3MANUF MANUFManufacturer ManufacturerACME

The sponsor applicant 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 Exposure (EX) domain to represent use of the tobacco product. Usage for the 2-week period is represented for each subject, along with the specified use during the in-clinic visit are shown. The sponsor applicant elected not to represent each puff in this EX dataset. Each Puff , although each puff could have been recorded.         

Dataset wrap
Nameex
Dataset2
RowSTUDYIDDOMAINUSUBJIDSPTOBIDEXSEQ
SPTOBID
EXLNKIDEXTRTEXDOSEEXDOSTXTEXDOSUEXDOSFRMEXROUTEEXPSTRGEXPSTRGUEXSTDTCEXENDTC
1TOPT001EX3001
1
EC-3331
Nicotine e-
nicotine
liquid
AD LIBITUM
INHALED

CARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-06-262020-07-14
2
TENDS01
TOPT001EX3001
2
EC-33321Nicotine e-
nicotine
liquid10
PUFFS

PUFFCARTRIDGERESPIRATORY (INHALATION)
INHALED
8mg/mL2020-07-15T9:002020-07-15TT9:45
3
TENDS01
TOPT001EX3001
3
EC-33332Nicotine e-
nicotine
liquid10
PUFFS

PUFFCARTRIDGERESPIRATORY (INHALATION)
INHALED
8mg/mL2020-07-15T3:002020-07-15TT3:45
4
TENDS01
TOPT001EX4001
1
EC-3331
Nicotine e-
nicotine
liquid
AD LIBITUM
INHALED

CARTRIDGERESPIRATORY (INHALATION)16mg/mL2020-09-062020-09-22
5
TENDS01
TOPT001EX4001
2
EC-33321Nicotine e-
nicotine
liquid10
PUFFS

PUFFCARTRIDGERESPIRATORY (INHALATION)
INHALED
16mg/mL2020-09-22T9:002020-09-22T9:30
6
TENDS01
TOPT001EX4001
3
EC-33332Nicotine e-
nicotine
liquid10
PUFF
PUFFS
CARTRIDGERESPIRATORY (INHALATION)
INHALED
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

The FAEX domain was used to represent the puff topography associated with the in-clinic visit. The Findings About Events or Interventions structure ("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. Only selected data for puffs 1 and 10 are shown. No data are shown for 2-9 to simplify dataset review. FATPT was used to represent the time point , (in this case, AM and PM).   Additonally , the vendor provided the mean of the measurements of 10 puffs in the mornings, and also in the afternoon. These derived means are included because they were provided by the vendor. If the sponsor had calculated the means, then these results would be represented in an ADaM datset .      Typically, applicants derive summary results using 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 applicant created an ADaM dataset to represent the summary data (not shown). 

Dataset wrap
Namefaex

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-288

Shows the mean puff volume for subject 3001. The means for the other tests are not shown. FACOLSRT indicates that this result is a calculated as a Mean
Rowcaps
Rows 1, 6:
Shows
Show the
Number
number of
Puff
puffs taken in the time interval specified in FADTC and FAENDTC.
 
This was
pre-specified
prespecified in the design, but the
sponsor
applicant reported the actual number of puffs taken.  
Rows 2-5:Show the various measurements recorded for subject 3001 for
Puff
puff 1 during the morning administration of the tobacco product. FADTC and FAENDTC
provides
provide the timing of each puff. The individual puff
.  
data for the afternoon are not shown. 
Rows 7-10:Show the various measurements recorded for subject 3001 for
Puff
puff 10 during the afternoon administration of the tobacco product. FADTC and FAENDTC
provides
provide the timing of each puff.
Note the
The individual puff data for
PUFFS 2-9
the morning session are not shown
to save space. 
Row 11
. Note: Data for puffs  2-9 are not shown to simplify dataset review.  
Rows 12-
15  
15:  
Shows
Show the various measurements recorded for subject 4001. Only a few rows are shown to
save space
simplify dataset review
  
    
FALOBXFL
Dataset2
RowSTUDYIDDOMAINUSUBJIDSPDEVIDSPTOBIDFASEQFALNKIDFASPIDFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESU
FACOLSRT
VISITNUMFADTCFAENDTCFATPT
1
TGI400
TOPT001FA3001PUFANYXYZEC-33311
PUFF TOT
TOTAL NUMBER OF PUFFS 
Total Number of PuffsNicotine e-
nicotine
liquid

PUFF TOPOGRAPHY

10PUFFS10PUFFS22020-07-
15T9
15T09:002020-07-15TT9:45

AM

2
TGI400
TOPT001FA3001PUFANYXYZEC-33321PUFF 1
PUFFVOL 
PUFFVOL
PUFF VOLUME
Puff VolumeNicotine e-
nicotine
liquid

PUFF TOPOGRAPHY

66
36.7
ml
mL/sec
98
37
ml
mL/sec2

2020-07-

15T9:00

15T09:01.36

2020-07-15T09:01.38

AM

3
TGI400

TOPT001

FA3001PUFANYXYZEC-33331PUFF 1AVGFLOWAverage Flow rateNicotine e-
nicotine
liquidPUFF TOPOGRAPHY15.5mL/sec15.5mL/sec22020-07-15T09:01.362020-07-15T09:01.38AM
4
TGI400
TOPT001FA3001PUFANYXYZEC-33341PUFF 1PKFLOWPeak Flow RateNicotine e-
nicotine
liquidPUFF TOPOGRAPHY20.5mL/sec20.5mL/sec22020-07-15T09:01.362020-07-15T09:01.38AM
5
TGI400
TOPT001FA3001PUFANYXYZEC-33351PUFF 1PUFFDURPuff DurationNicotine e-
nicotine liqui
liquidPUFF TOPOGRAPHY
6
2.0msec1.6msec22020-07-15T09:01.362020-07-15T09:01.38AM
6

TOPT001

TGI400

FA3001PUFANYXYZEC-33362
PUFF TOT
TOTAL NUMBER OF PUFFS 
Total Number of Puffse-
nicotine
nicotin liquid

PUFF TOPOGRAPHY

10
9PUFFS
10
9PUFFS22020-07-15T03:002020-07-15T03:30PM
7
TGI400
TOPT001FA3001PUFANYXYZEC-33372PUFF 10INTPUFINPuff IntervalNicotine e-
nicotine liqui
liquidPUFF TOPOGRAPHY
AM
910396.8sec910396.8sec22020-07-15T03:30:342020-07-15T03:30:36PM
8
TGI400
TOPT001FA3001PUFANYXYZEC-33382PUFF
10 
10
PUFFVOL 
PUFFVOL
PUFF VOLUME 
Puff VolumeNicotine e-
nicotine
liquidPUFF TOPOGRAPHY43
ml
mL/sec43
ml
mL/sec22020-07-15T03:30:342020-07-
15T9
15T03:30:
11
36
AM

PM

9
TGI400

TOPT001

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

PM

10TOPT001
TGI400
FA3001PUFANYXYZEC-333102PUFF 10PKFLOWPeak Flow RateNicotine e-
nicotine
liquidPUFF TOPOGRAPHY
11

TGI400

FA3001PUFANYXYZ11PUFFVOLPUFF VOLUMEe-nicotine liquidPUFF TOPOGRAPHY53.7
22.5mL
ml
/sec
53
22.
7
5
ml
mL/sec
MEAN
22020-07-
15T9
15T03:30:
00
342020-07-
15TT9
15T03:30:
45
36
AM

PM

12
TGI400
TOPT001FA4001PUFANYXYZEC-33311
PUFF TOT
TOTAL NUMBER OF PUFFS 
Total Number of PuffsNicotine e-
nicotine
liquid

PUFF TOPOGRAPHY

10PUFFS10PUFFS22020-
07
08-15T9:002020-
07
08-15TT9:45

AM

13
TGI400

TOPT001

FA4001PUFANYXYZEC-33321PUFF 1
PUFFVOL 
PUFFVOL
PUFF VOLUME
Puff VolumeNicotine e-
nicotine
liquidPUFF TOPOGRAPHY
2
34.7mL/sec
2
34mL/sec22020-08-15T09:01.362020-
07-22
08-15T09:01.38AM
14
TGI400
TOPT001FA4001PUFANYXYZEC-33331PUFF 1AVGFLOWAverage Flow rateNicotine e-
nicotine
liquidPUFF TOPOGRAPHY
1
15.
8
5mL/sec
1
15.
8
5mL/sec22020-08-15T09:01.362020-
07-22
08-15T09:01.38AM
15
TGI400
TOPT001FA4001PUFANYXYZEC-33341PUFF 1PKFLOWPeak Flow RateNicotine e-
nicotine
liquidPUFF TOPOGRAPHY
1
23.
8
5mL/sec
1
23.
8
5mL/sec22020-
09
08-
22T9
15T09:
13
01.362020-
09
08-
22T9
15T09:
30
01.38AM



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

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