In this study, subjects were randomized to one of three nicotine dosage levels. At the baseline visit (Week 0), they receiving an ENDS device that used 0, 8 or 36 mg/ml nicotine liquid. Self-reported daily cigarette consumption were recorded for each day of the study for 4 weeks. The subjects were supplied replacement nicotine cartridges at each weekly visit. The sponsor used an electronic diary application to track when the cartridge were replaced, and the daily number of cigarettes smoked. The subject used their normal brand cigarettes, and these were not supplied by the sponsor, and not considered a study product. Each cartridge was 8 mL. No other Nicotine replacement products were allowed to be used. Multiple cartridges were dispensed at a visit.
The sponsor reported the cigarettes used in the in the SU domain. The number of cigarettes smoked for each day of the study after the first visit were represented. If no cigarettes were smoked, a 0 was recorded. Only a few rows are shown.
su.xpt
xx.xpt
Row
STUDYID
DOMAIN
USUBJID
SUSEQ
SUTRT
SUCAT
SUDOSE
SUDOSU
SUDOSFRQ
SUSTDTC
SUENDTC
1
TENDS01
SU
ABC-01001
1
CIGARETTES
TOBACCO
6
CIGARETTE
PER DAY
2020-06-27
2020-06-27
2
TENDS01
SU
ABC-01001
1
CIGARETTES
TOBACCO
1
CIGARETTE
PER DAY
2020-06-28
2020-06-28
3
TENDS01
SU
ABC-01001
1
CIGARETTES
TOBACCO
0
CIGARETTE
PER DAY
2020-06-29
2020-06-29
$warningHtml
A Product Accountability domain was submitted to represent dispensed and returned amounts. Each cartridge had a uniquely assigned number. This unique number was represented in DAREF. Multiple cartridges were dispensed at weekly visits, but each cartridge was tracked. At each weekly visit, all previously dispended cartridges were returned, and new cartridges dispensed. Cartridges were replaced at each visit. DADTC are the visit dates when the cartridge was returned or dispensed. Cartridges not used were record as having the full volume returned.
da.xpt
xx.xpt
Row
STUDYID
DOMAIN
USUBJID
DASEQ
DAREF
DATESTCD
DATEST
DACAT
DAORRES
DAORRESU
DASTRESC
DASTRESN
DASTRESU
VISITNUM
DADTC
1
ABC
DA
ABC-01001
1
CRT8754
DISPAMT
Dispensed Amount
STUDY PRODUCT
8
mL
8
8
mL
1
2004-06-26
2
ABC
DA
ABC-01001
2
CRT8768
DISPAMT
Dispensed Amount
STUDY PRODUCT
8
mL
8
8
mL
1
2004-06-26
3
ABC
DA
ABC-01001
3
CRT8769
DISPAMT
Dispensed Amount
STUDY PRODUCT
8
mL
8
8
mL
1
2004-06-26
4
ABC
DA
ABC-01001
4
CRT8754
RETAMT
Returned Amount
STUDY PRODUCT
2
mL
6
6
mL
2
2020-07-06
2
ABC
DA
ABC-01001
5
CRT8768
RETAMT
Returned Amount
STUDY PRODUCT
1.6
mL
8
8
mL
2
2020-07-06
3
ABC
DA
ABC-01001
6
CRT8769
RETAMT
Returned Amount
STUDY PRODUCT
8
mL
8
8
mL
2
2020-07-06
5
ABC
DA
ABC-01001
7
CRT9756
DISPAMT
Dispensed Amount
STUDY PRODUCT
8
mL
8
8
mL
2
2020-07-06
6
ABC
DA
ABC-01001
8
CRT9756
RETAMT
Returned Amount
STUDY PRODUCT
1.0
mL
1.3
1.3
mL
3
2020-07-10
Dataset Debug Message
There is a leading, trailing, or non-breaking space in the dataset.
Since the data in Exposure as collected (EC) would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain. The sponsor unblinded the study before creating the EX domain. The unblinded product name is provided in EXTRT, here a dummy name is used for the tobacco product.
The domain represented the number of cartridges used (in this example always 1 since each cartridge was tracked), the total amount amount of liquid product used determined from the DA domain and the associated nicotine pharmaceutical strength of each cartridge. The sponsored used this information in the analysis. The summaries included in the analysis were the estimated number of cartridges used per week, and the estimated nicotine exposer from the cartridges per day.
$titleHtml
ex.xpt
Row
STUDYID
DOMAIN
USUBJID
EXSEQ
EXREF
EXTRT
EXDOSE
EXDOSU
EXROUTE
EXVAMT
EXVAMTU
EXPSTRG
EXPSTRG
EXSTDTC
EXENDTC
1
TENDS01
EX
10001
1
CRT8754
Tobacco X1 Nicotine Cartridge
1
CONTAINER
INHALED
6
mL
8
mg/mL
2020-06-26
2020-07-01
2
TENDS01
EC
10001
2
CRT8768
Tobacco X1 Nicotine Cartridge
1
CONTAINER
INHALED
6.7
mL
8
mg/mL
2020-07-01
2020-07-06
3
TENDS01
EC
10001
3
CRT9756
Tobacco X1 Nicotine Cartridge
1
CONTAINER
INHALED
7
mL
8
mg/mL
2020-07-06
2020-07-10
3
TENDS01
EC
10001
4
CRT9778
Tobacco X1 Nicotine Cartridge
1
CONTAINER
INHALED
8
mL
8
mg/mL
2020-07-10
2020-07-14
4
TENDS01
EC
10002
5
CRT8000
Tobacco X2 Nicotine Cartridge
1
CONTAINER
INHALED
5
mL
36
mg/mL
2020-09-01
2020-09-07
5
TENDS01
EC
10002
6
CRT9006
Tobacco X2 Nicotine Cartridge
1
CONTAINER
INHALED
7
mL
36
mg/mL
2020-09-07
2020-09-14
6
TENDS01
EC
10002
7
CRT9008
Tobacco X2 Nicotine Cartridge
1
CONTAINER
INHALED
8
mL
36
mg/mL
2020-09-14
2020-09-21
7
TENDS01
EC
10002
8
CRT9017
Tobacco X2 Nicotine Cartridge
1
CONTAINER
INHALED
6
mL
36
mg/mL
2020-09-21
2020-09-28
8
TENDS01
EC
10002
9
CRT9089
Tobacco X2 Nicotine Cartridge
1
CONTAINER
INHALED
7
mL
36
mg/mL
2020-09-28
2020-09-31
9
TENDS01
EC
10002
10
CRT9128
Tobacco X2 Nicotine Cartridge
1
CONTAINER
INHALED
8
mL
36
mg/mL
2020-10-31
2020-10-08
10
TENDS01
EC
10002
1
CRT6868
Tobacco X2 Nicotine Cartridge
1
CONTAINER
INHALED
6.7
mL
36
mg/mL
2020-10-08
2020-10-15
11
TENDS01
EC
10002
2
CRT7868
Tobacco X2 Nicotine Cartridge
1
CONTAINER
INHALED
5.5
mL
36
mg/mL
2020-10-15
2020-10-22
Dataset Debug Messages
There are 23 leading, trailing, or non-breaking spaces in the dataset.
There seem to be multiple domains (EX, EC) present in the dataset.
There is a duplicate variable (EXPSTRG) in the dataset.