The examples below illustrate various methods for displaying study product exposure data, as well as data that may be collected on the usage of other nicotine sources. Multiple examples are provided to illustrate specific exposure based on how it was measured (e.g., by volume, by weight or number of product consumed).
The example below illustrate various methods for displaying study product exposure data, as well as data that may be collected on the usage of other nicotine sources.
In the following example, the sponsor reported protocol described usage of a nicotine inhaler using the EX and EC domains. Usage of non-protocol defined product usage (alcohol and other tobacco products) during the study were represented in the SU domain. Additionally, any usage of nicotine patches to reduce dependency on tobacco were reported in the CM domain. Study product exposure was represented as the number of cartridges used. The pharmaceutical strength of each cartridge was represented.
In this example, exposure is based on the number of product used.
Example
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In this example, the EC domain is not used by the sposnor to represent collected exposure. Expoure was represented based on the volume of the e-nicotine liquid cartridges.
Example
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In this example, both the EC and EX domains are used. Exposure was based on the weight of the e-nicotine liquid cartridges.
Example
In this study, subjects were randomized to either nicotine replacement patches or ENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devices. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every day for 15 days. The nicotine patch was applied, at rotating sites, and the nicotine cartridge was replaced every day. The cartridge was weighed when dispensed and upon return. On days, 1, 5, and 10 subjects remained in the clinic for 4 hours for collection of biomarkers. On these days, a new ENDS nicotine cartridge was inserted and 10 puffs were taken over 10 minutes, and not used for the remaining collection period. A new cartridge was inserted at the end of the 4-hour collection period. A nicotine replacement patch was applied prior to using the ENDS device on these days.
The SU domain was used to represent the number of cigarettes used, but is not shown.
In this study, the weight of the contents in the cartridge was tracked. The DA domain was used to represent dispensed and returned weights of each cartridge. Only a few rows are shown. The product accountability information was not provided for the nicotine replacement patches.
da.xpt
xx.xpt
Row
STUDYID
DOMAIN
USUBJID
DASEQ
DAREFID
DATESTCD
DATEST
DACAT
DASCAT
DAORRES
DAORRESU
DASTRESC
DASTRESN
DASTRESU
VISITNUM
DADTC
1
TEDP07
DA
10001
1
CRT8754
DISPAMT
Dispensed Amount
STUDY PRODUCT
E-LIQUID
25.3
g
25
25
g
1
2004-06-06
2
TEDP07
DA
10001
2
CRT8754
RETAMT
Returned Amount
STUDY PRODUCT
E-LIQUID
23
g
23
23
g
1
2020-06-06
3
TEDP07
DA
10001
3
CRT9756
DISPAMT
Dispensed Amount
STUDY PRODUCT
E-LIQUID
25.1
g
25
25
g
1
2020-06-07
4
TEDP07
DA
10001
4
CRT9756
RETAMT
Returned Amount
STUDY PRODUCT
E-LIQUID
10
g
14
14
g
2
2020-06-08
5
TEDP07
DA
10001
5
CRT9955
DISPAMT
Dispensed Amount
STUDY PRODUCT
E-LIQUID
25.2
g
25
25
g
2
2004-06-08
$warningHtml
EC was used to represent the collected exposure data since a double-blind design was used. The EX domain was used to represent the subject's exposure to the actual product containing nicotine. The applicant represented each cartridge and patch used. The dose was represented as "1" to indicate 1 cartridge or patch. The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was recorded on other days.
$titleHtml
ec.xpt
Row
STUDYID
DOMAIN
USUBJID
ECSEQ
ECTRT
ECDOSE
ECDOSTXT
ECDOSU
ECDOSFRM
ECROUTE
ECLOC
ECLAT
ECDIR
EPOCH
ECSTDTC
ECENDTC
1
TEDP07
EC
10001
1
ENDS
10
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
2020-06-01T08:00
2020-06-01T08:10
2
TEDP07
EC
10001
2
PATCH
1
PATCH
PATCH
TRANSDERMAL
ARM
RIGHT
UPPER
PRODUCT EXPOSURE
2020-06-01
2020-06-02
3
TEDP07
EC
10001
3
ENDS
AD LIBITUM
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
2020-06-01T12:10
2020-06-02
4
TEDP07
EC
10001
4
ENDS
AD LIBITUM
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
2020-06-02
2020-06-03
5
TEDP07
EC
10001
5
PATCH
1
PATCH
PATCH
TRANSDERMAL
ARM
LEFT
UPPER
PRODUCT EXPOSURE
2020-06-02
2020-06-03
6
TEDP07
EC
10001
6
ENDS
AD LIBITUM
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
2020-06-03
2020-06-04
7
TEDP07
EC
10001
7
PATCH
1
PATCH
PATCH
TRANSDERMAL
LEG
LEFT
UPPER
PRODUCT EXPOSURE
2020-06-03
2020-06-04
7
TEDP07
EC
10001
8
ENDS
AD LIBITUM
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
2020-06-04
2020-06-05
8
TEDP07
EC
10001
9
PATCH
1
PATCH
PATCH
TRANSDERMAL
LEG
LEFT
LOWER
PRODUCT EXPOSURE
2020-06-04
2020-06-05
9
TEDP07
EC
10001
10
ENDS
10
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
2020-06-10T8:30
2020-06-10T8:40
10
TEDP07
EC
10001
11
PATCH
1
PATCH
PATCH
TRANSDERMAL
LEG
RIGHT
LOWER
PRODUCT EXPOSURE
2020-06-10
2020-06-11
11
TEDP07
EC
10001
12
ENDS
AD LIBITUM
PUFF
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
2020-06-10T12:40
2020-06-11
$warningHtml
Subject 10001 was randomized to the 5% pharmaceutical strength of the nicotine e-liquid, and subject 20001 was randomized to the nicotine patch with a pharmaceutical strength of 14mg. The applicant only represented the active product exposure for each subject in EX.
$titleHtml
ex.xpt
Row
STUDYID
DOMAIN
USUBJID
EXSEQ
EXTRT
EXDOSE
EXDOSU
EXDOSFRM
EXROUTE
EXLOC
EXLAT
EXDIR
EPOCH
EXPSTRG
EXPSTRGU
EXSTDTC
EXENDTC
1
TEDP07
EX
10001
1
e nicotine liquid
1.7
g
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
5
%
2020-06-01T08:00
2020-06-01T:8:10
2
TEDP07
EX
10001
2
e nicotine liquid
15.1
g
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
5
%
2020-06-01T12:10
2020-06-02
3
TEDP07
EX
10001
3
e nicotine liquid
13
g
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
5
%
2020-06-02
2020-06-03
4
TEDP07
EX
10001
4
e nicotine liquid
12
g
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
5
%
2020-06-03
2020-06-04
5
TEDP07
EX
10001
5
e nicotine liquid
9
g
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
5
%
2020-06-04
2020-06-05
6
TEDP07
EX
10001
6
e nicotine liquid
7
g
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
5
%
2020-06-10T08:30
2020-06-10T08:40
7
TEDP07
EX
10001
7
e nicotine liquid
5
g
CARTRIDGE
RESPIRATORY (INHALATION)
PRODUCT EXPOSURE
5
%
2020-06-10T12:40
2020-06-11
8
TEDP07
EX
20001
1
nicotine replacement therapy
1
PATCH
PATCH
TRANSDERMAL
ARM
RIGHT
UPPER
PRODUCT EXPOSURE
14
mg
2020-06-01
2020-06-02
9
TEDP07
EX
20001
2
nicotine replacement therapy
1
PATCH
PATCH
TRANSDERMAL
ARM
LEFT
UPPER
PRODUCT EXPOSURE
14
mg
2020-06-02
2020-06-03
10
TEDP07
EX
20001
3
nicotine replacement therapy
1
PATCH
PATCH
TRANSDERMAL
LEG
LEFT
UPPER
PRODUCT EXPOSURE
14
mg
2020-06-03
2020-06-04
11
TEDP07
EX
20001
4
nicotine replacement therapy
1
PATCH
PATCH
TRANSDERMAL
LEG
LEFT
LOWER
PRODUCT EXPOSURE
14
mg
2020-06-04
2020-06-05
12
TEDP07
EX
20001
5
nicotine replacement therapy
1
PATCH
PATCH
TRANSDERMAL
LEG
RIGHT
LOWER
PRODUCT EXPOSURE
14
mg
2020-06-10
2020-06-11
$warningHtml
In this example, subjects were exposed to mulitple study products. The actual dates and times of use for each product is represented.
Example
This is an example of a crossover study testing 7 smokeless tobacco products. All products contain nicotine except for product F, which was a nicotine-/tobacco-free product. Each subject first used the product ad libitum; the next day, the product usage was evaluated in the morning, as specified in the protocol. Subjects were confined to the site. Products were supplied to the subjects as needed by site staff. Each usage was recorded. The applicant did not submit a DA domain, nor an EC domain. The name of the actual product would be used, but a dummy name is used in this example.