In this study, subjects were randomized to nicotine lozenges or placebo. Subject were allowed to smoke cigarettes.
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
CIGARETTE
TOBACCO
6
CIGARETTE
PER DAY
2020-06-27
2020-06-27
2
TENDS01
SU
ABC-01001
1
CIGARETTE
TOBACCO
1
CIGARETTE
PER DAY
2020-06-28
2020-06-28
3
TENDS01
SU
ABC-01001
1
CIGARETTE
TOBACCO
0
CIGARETTE
PER DAY
2020-06-29
2020-06-29
$warningHtml
A Product Accountability (DA) domain was submitted to represent dispensed and returned amounts. At each visit the subject was supplied with 2 bottles of lozenges that contained 40 lozenges each. The number of lozenges returned were counted.
da.xpt
xx.xpt
Row
STUDYID
DOMAIN
USUBJID
DASEQ
DATEST
DACAT
DAORRES
DAORRESU
DASTRESC
DASTRESN
DASTRESU
DASTAT
DAREASND
VISITNUM
DADTC
1
ABC
DA
ABC-01001
1
Dispensed Amount
STUDY PRODUCT
1
8
8
mL
1
2004-06-26
2
ABC
DA
ABC-01001
2
Dispensed Amount
STUDY PRODUCT
8
mL
8
8
mL
1
2004-06-26
3
ABC
DA
ABC-01001
3
Dispensed Amount
STUDY PRODUCT
8
mL
8
8
mL
1
2004-06-26
4
ABC
DA
ABC-01001
4
Returned Amount
STUDY PRODUCT
NOT DONE
Subject forgot to return the cartridge
2020-07-06
5
ABC
DA
ABC-01001
5
Returned Amount
STUDY PRODUCT
1.6
mL
8
8
mL
2
2020-07-06
6
ABC
DA
ABC-01001
6
Returned Amount
STUDY PRODUCT
8
mL
8
8
mL
2
2020-07-06
7
ABC
DA
ABC-01001
7
Dispensed Amount
STUDY PRODUCT
8
mL
8
8
mL
2
2020-07-06
8
ABC
DA
ABC-01001
8
Returned Amount
STUDY PRODUCT
1.0
mL
1.3
1.3
mL
3
2020-07-10
9
ABC
DA
ABC-01001
4
Returned Amount
STUDY PRODUCT
2
mL
6
6
mL
3
2020-07-06
Dataset Debug Messages
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
EXREFID
EXTRT
EXDOSE
EXDOSU
EXROUTE
EXPSTRG
EXPSTRG
EXSTDTC
EXENDTC
1
TENDS01
EX
10001
1
CRT8754
e-liquid
6
mL
INHALED
8
mg/mL
2020-06-26
2020-07-01
2
TENDS01
EC
10001
2
CRT8768
e-liquid
6.7
mL
INHALED
8
mg/mL
2020-07-01
2020-07-06
3
TENDS01
EC
10001
3
CRT9756
e-liquid
7
mL
INHALED
8
mg/mL
2020-07-06
2020-07-10
3
TENDS01
EC
10001
4
CRT9778
e-liquid
8
mL
INHALED
8
mg/mL
2020-07-10
2020-07-14
4
TENDS01
EC
10002
5
CRT8000
e-liquid
5
mL
INHALED
36
mg/mL
2020-09-01
2020-09-07
5
TENDS01
EC
10002
6
CRT9006
e-liquid
7
mL
INHALED
36
mg/mL
2020-09-07
2020-09-14
6
TENDS01
EC
10002
7
CRT9008
e-liquid
8
mL
INHALED
36
mg/mL
2020-09-14
2020-09-21
7
TENDS01
EC
10002
8
CRT9017
e-liquid
6
mL
INHALED
36
mg/mL
2020-09-21
2020-09-28
8
TENDS01
EC
10002
9
CRT9089
e-liquid
7
mL
INHALED
36
mg/mL
2020-09-28
2020-09-31
9
TENDS01
EC
10002
10
CRT9128
e-liquid
8
mL
INHALED
36
mg/mL
2020-10-31
2020-10-08
10
TENDS01
EC
10002
1
CRT6868
e-liquid
6.7
mL
INHALED
36
mg/mL
2020-10-08
2020-10-15
11
TENDS01
EC
10002
2
CRT7868
e-liquid
5.5
mL
INHALED
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.