Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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 Topography PUFF TOPOGRAPHY ANALYZER
2TOPT001DIPUFANYXYZ2MODELModelPUFFALYZER 900
3TOPT001DIPUFANYXYZ3MANUFManufacturerACME

The applicant submitted the 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 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 applicant elected not to represent each puff in this EX dataset, 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
TOPT001EX
40013
3001EC-33332Nicotine e-liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)8mg/mL2020-07-15T3:002020-07-15TT3:45
4TOPT001EX4001EC-3331
Nicotine e-
nicotine
liquid
AD LIBITUM
INHALED

CARTRIDGERESPIRATORY (INHALATION)16mg/mL2020-09-062020-09-22
3
5
TENDS01
TOPT001EX4001
EC-33321Nicotine e-liquid10
PUFFCARTRIDGERESPIRATORY (INHALATION)16mg/mL2020-09-22T9:002020-09-22T9:30
6TOPT001EX4001
4
EC-33332Nicotine e-
nicotine
liquid10
PUFFS

PUFFCARTRIDGERESPIRATORY (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. Additionally , the vendor provided the mean puff volume and the mean puff duration for the 10 puffs in the session.    . 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). 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

Rowcaps
Row
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-
3,
5
-6 
:Show the
puff volume for Subject
various measurements recorded for subject 3001 for
each puff and the puff duration for Subject 4001. 
puff 1 during the morning administration of the tobacco product. FADTC and FAENDTC
provides
provide the timing of each puff.
Only
The individual puff data for
2 puffs
the afternoon are not shown.
  
 
Rows
4 & 7  
7-10: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: 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.    
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.
 
FAMETHOD
Dataset2
RowSTUDYIDDOMAINUSUBJIDSPDEVIDSPTOBIDFASEQFALNKIDFASPIDFATESTCDFATESTFAOBJFACATFAORRESFAORRESUFASTRESCFASTRESU
FALOBXFL
VISITNUMFADTCFAENDTCFATPT
FACOLSRT
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

1
2
TGI400
TOPT001FA3001PUFANYXYZEC-3332
PUFFVOL 
1PUFF
VOLUME
1PUFFVOLPuff VolumeNicotine e-
nicotine
liquid

PUFF TOPOGRAPHY

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

2020-07-15T09:01.36

2020-07-

15T9

15T09:

00

PUFF 1

01.38

AM

3

TOPT001

2TGI400

FA3001PUFANYXYZEC-3333
PUFFVOL 
1PUFF
VOLUME 
1AVGFLOWAverage Flow rateNicotine e-
nicotine
liquidPUFF TOPOGRAPHY
43
15.5
ml
mL/sec
43
15.5
ml
mL/sec22020-07-
15T9:11PUFF 23
15T09:01.362020-07-15T09:01.38AM
4TOPT001
TGI400
FA3001PUFANYXYZEC-3334
PUFFVOL
1PUFF
VOLUME
1PKFLOWPeak Flow RateNicotine e-
nicotine
liquidPUFF TOPOGRAPHY
53
20.
7
5
ml
mL/sec
53
20.
7
5
ml
mL/sec
DEVICE ALGORITHM
22020-07-
15T9
15T09:
00
01.362020-07-
15TT9
15T09:
45
01.38
MEAN
AM
4
5
TGI400
TOPT001FA
4001
3001PUFANYXYZEC-33351PUFF 1PUFFDUR
PUFF DURATION
Puff DurationNicotine e-liquidPUFF TOPOGRAPHY2.0msec1.6msec22020-07-15T09:01.362020-07-15T09:01.38AM
6

TOPT001

FA3001PUFANYXYZEC-33362
PUFF TOTTotal Number of Puffse-
nicotine
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-
22PUFF 1
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-
5

TGI400

FA4001PUFANYXYZ2PUFFDURPUFF DURATIONe-nicotine
liquidPUFF TOPOGRAPHY
1
22.
8
5mL/sec
1
22.
8
5mL/sec22020-07-15T03:30:342020-07
-22PUFF 2 
-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

6TGI400

FA4001PUFANYXYZ
3PUFFDURPUFF DURATION
EC-33321PUFF 1PUFFVOLPuff VolumeNicotine e-
e-nicotine
liquidPUFF TOPOGRAPHY
1.8sec1.8sec
34.7mL/sec34mL/sec22020-08-15T09:01.362020-08-15T09:01.38AM
14TOPT001FA4001PUFANYXYZEC-33331PUFF 1AVGFLOWAverage Flow rateNicotine e-liquidPUFF TOPOGRAPHY15.5mL/sec15.5mL/sec
DEVICE ALGORITHM
22020-
09
08-
22T9
15T09:
13
01.362020-
09
08-
22T9
15T09:
30
01.38
MEAN
AM
nsvmeta
15
Domain
TOPT001FA
4001PUFANYXYZEC-33341PUFF 1PKFLOWPeak Flow RateNicotine e-liquidPUFF TOPOGRAPHY23.5mL/sec23.5mL/sec22020-08-15T09:01.362020-08-15T09:01.38AM



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

Dataset wrap
Namerelrec
CRF
Dataset2

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1TD23EX
EXLNKID
ONEEXFA1
2TD23FAEX
FALNKID
MANYEXFA1
VariableLabelTypeRoleCODELISTOrigin
FACOLSRTCollected Summary Result TypetextNon-standard Record Qualifier(COLSTYP)