Smoking/Vaping topography is how the smoker smokes/vapes a tobacco product. Measures of vaping/smoking behavior is critical to understand exposures to biomarkers of nicotine exposure and toxins. There are topography devices that are used to measure cigarette puffing behavior, these devices may also be used evaluate electronic cigarette use. There are also calibrated laboratory-based smoking puff analyzer devices that are combined with an analytical smoking machine that generates programmable puffs with high precision. Puff, inhalation and exhalation duration; puff volume; inter puff interval are often measured. Sponsors may find information in a Technical Document has been published on the CORESTA website (Oct 2022): Assessing Product Use Behaviour and Exposure: Definitions and Methods.
Puff topography is typically considered data about the subject exposure to the test product. As these data represent information about study product exposure, the data is represented in the Exposure (EX) domain. More information on the Exposure domain is found here. Exposure Assessments During a Trial
Puff topography is often measured using Smoking Machines. Information about Devices are represented using the SDTM Medical Devices Domain. These domains represent information about devices and not study subject or the trial itself.
Example
This is a study where subjects were randomized to 3 different concentrations of nicotine e-liquid, or their usual brand of cigarettes. The subjects used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After 2 weeks, subjects were confined to the clinic for 1 day. They were required to not use any tobacco products for 12 hours prior to the visit. Subjects had to have CO levels below a prespecified level to attend the visit. If the level was too high, the visit was rescheduled. 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, was used to identify the device used to measure puff topography. This provides a consistent variable (SPDEVID) for linking data. Because device identifiers exist independently from subjects, the DI domain does not contain USUBJID. Only 1 device was used for all subjects in the study.
di.xpt
di.xpt
Row
STUDYID
DOMAIN
SPDEVID
DISEQ
DIPARMCD
DIPARM
DIVAL
1
TOPT001
DI
PUFANYXYZ
1
DEVTYPE
Device Type
PUFF TOPOGRAPHY ANALYZER
2
TOPT001
DI
PUFANYXYZ
2
MODEL
Model
PUFFALYZER 900
3
TOPT001
DI
PUFANYXYZ
3
MANUF
Manufacturer
ACME
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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 during the in-clinic visit. The applicant elected not to represent each puff in this EX dataset, although each puff could have been recorded.
ex.xpt
ex.xpt
Row
STUDYID
DOMAIN
USUBJID
SPTOBID
EXSEQ
EXLNKID
EXTRT
EXDOSE
EXDOSTXT
EXDOSU
EXDOSFRM
EXROUTE
EXPSTRG
EXPSTRGU
EXSTDTC
EXENDTC
1
TOPT001
EX
3001
EC-333
1
Nicotine e-liquid
AD LIBITUM
CARTRIDGE
RESPIRATORY (INHALATION)
8
mg/mL
2020-06-26
2020-07-14
2
TOPT001
EX
3001
EC-333
2
1
Nicotine e-liquid
10
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
8
mg/mL
2020-07-15T9:00
2020-07-15TT9:45
3
TOPT001
EX
3001
EC-333
3
2
Nicotine e-liquid
10
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
8
mg/mL
2020-07-15T3:00
2020-07-15TT3:45
4
TOPT001
EX
4001
EC-333
1
Nicotine e-liquid
AD LIBITUM
CARTRIDGE
RESPIRATORY (INHALATION)
16
mg/mL
2020-09-06
2020-09-22
5
TOPT001
EX
4001
EC-333
2
1
Nicotine e-liquid
10
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
16
mg/mL
2020-09-22T9:00
2020-09-22T9:30
6
TOPT001
EX
4001
EC-333
3
2
Nicotine e-liquid
10
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
16
mg/mL
2020-09-22T3:00
2020-09-22T3:30
7
TOPT001
EX
5004
1
Cigarettes Brand XYZ
AD LIBITUM
CIGARETTE
RESPIRATORY (INHALATION)
12.1
mg/cigarette
2020-10-08
2020-10-22
8
TOPT001
EX
5004
2
1
Cigarettes Brand XYZ
10
PUFF
CIGARETTE
RESPIRATORY (INHALATION)
12.1
mg/cigarette
2020-10-22T9:00
2020-09-22T9:30
9
TOPT0011
EX
5004
3
2
Cigarettes Brand XYZ
10
PUFF
CIGARETTE
RESPIRATORY (INHALATION)
12.1
mg/cigarette
2020-10-22T3:00
2020-09-22T3:30
$warningHtml
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). 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).
Show the number of puffs taken in the time interval specified in FADTC and FAENDTC. This was prespecified in the design, but the applicant 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 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.
fa.xpt
faex.xpt
Row
STUDYID
DOMAIN
USUBJID
SPDEVID
SPTOBID
FASEQ
FALNKID
FASPID
FATESTCD
FATEST
FAOBJ
FACAT
FAORRES
FAORRESU
FASTRESC
FASTRESU
VISITNUM
FADTC
FAENDTC
FATPT
1
TOPT001
FA
3001
PUFANYXYZ
EC-333
1
1
PUFF TOT
Total Number of Puffs
Nicotine e-liquid
PUFF TOPOGRAPHY
10
PUFFS
10
PUFFS
2
2020-07-15T09:00
2020-07-15TT9:45
AM
2
TOPT001
FA
3001
PUFANYXYZ
EC-333
2
1
PUFF 1
PUFFVOL
Puff Volume
Nicotine e-liquid
PUFF TOPOGRAPHY
36.7
mL/sec
37
mL/sec
2
2020-07-15T09:01.36
2020-07-15T09:01.38
AM
3
TOPT001
FA
3001
PUFANYXYZ
EC-333
3
1
PUFF 1
AVGFLOW
Average Flow rate
Nicotine e-liquid
PUFF TOPOGRAPHY
15.5
mL/sec
15.5
mL/sec
2
2020-07-15T09:01.36
2020-07-15T09:01.38
AM
4
TOPT001
FA
3001
PUFANYXYZ
EC-333
4
1
PUFF 1
PKFLOW
Peak Flow Rate
Nicotine e-liquid
PUFF TOPOGRAPHY
20.5
mL/sec
20.5
mL/sec
2
2020-07-15T09:01.36
2020-07-15T09:01.38
AM
5
TOPT001
FA
3001
PUFANYXYZ
EC-333
5
1
PUFF 1
PUFFDUR
Puff Duration
Nicotine e-liquid
PUFF TOPOGRAPHY
2.0
msec
1.6
msec
2
2020-07-15T09:01.36
2020-07-15T09:01.38
AM
6
TOPT001
FA
3001
PUFANYXYZ
EC-333
6
2
PUFF TOT
Total Number of Puffs
e-nicotin liquid
PUFF TOPOGRAPHY
9
PUFFS
9
PUFFS
2
2020-07-15T03:00
2020-07-15T03:30
PM
7
TOPT001
FA
3001
PUFANYXYZ
EC-333
7
2
PUFF 10
INTPUFIN
Puff Interval
Nicotine e-liquid
PUFF TOPOGRAPHY
910396.8
sec
910396.8
sec
2
2020-07-15T03:30:34
2020-07-15T03:30:36
PM
8
TOPT001
FA
3001
PUFANYXYZ
EC-333
8
2
PUFF 10
PUFFVOL
Puff Volume
Nicotine e-liquid
PUFF TOPOGRAPHY
43
mL/sec
43
mL/sec
2
2020-07-15T03:30:34
2020-07-15T03:30:36
PM
9
TOPT001
FA
3001
PUFANYXYZ
EC-333
9
2
PUFF 10
AVGFLOW
Average Flow rate
Nicotine e-liquid
PUFF TOPOGRAPHY
14.5
mL/sec
14.5
mL/sec
2
2020-07-15T03:30:34
2020-07-15T03:30:36
PM
10
TOPT001
FA
3001
PUFANYXYZ
EC-333
10
2
PUFF 10
PKFLOW
Peak Flow Rate
Nicotine e-liquid
PUFF TOPOGRAPHY
22.5
mL/sec
22.5
mL/sec
2
2020-07-15T03:30:34
2020-07-15T03:30:36
PM
12
TOPT001
FA
4001
PUFANYXYZ
EC-333
1
1
PUFF TOT
Total Number of Puffs
Nicotine e-liquid
PUFF TOPOGRAPHY
10
PUFFS
10
PUFFS
2
2020-08-15T9:00
2020-08-15TT9:45
AM
13
TOPT001
FA
4001
PUFANYXYZ
EC-333
2
1
PUFF 1
PUFFVOL
Puff Volume
Nicotine e-liquid
PUFF TOPOGRAPHY
34.7
mL/sec
34
mL/sec
2
2020-08-15T09:01.36
2020-08-15T09:01.38
AM
14
TOPT001
FA
4001
PUFANYXYZ
EC-333
3
1
PUFF 1
AVGFLOW
Average Flow rate
Nicotine e-liquid
PUFF TOPOGRAPHY
15.5
mL/sec
15.5
mL/sec
2
2020-08-15T09:01.36
2020-08-15T09:01.38
AM
15
TOPT001
FA
4001
PUFANYXYZ
EC-333
4
1
PUFF 1
PKFLOW
Peak Flow Rate
Nicotine e-liquid
PUFF TOPOGRAPHY
23.5
mL/sec
23.5
mL/sec
2
2020-08-15T09:01.36
2020-08-15T09:01.38
AM
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The RELREC dataset was used to record the relationship between the records in EX and the records in FAEX.