1: This is an example of a blinded study using double dummy packaging. Are these types of studies done?
2. The Weights are made up- we need team help in providing real weight amounts.
3. The strength of the cartridge- WE see these like Joules says 5% , while other use mg/ML. What should be used, as a measure of the strength.
In this study, subjects were randomized were randomized to either nicotine replacement patches or ENDs device which used e nicotine liquid. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS device. 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 ENDS cartridge was replaced every day. The cartridge was weight when dispended and upon return. On days, 1, 5, 10 subjects remained in the clinic for 4 hours for collection of biomarkers. On these days, a new ENDS cartridge device was inserted and then used for 10 minutes, and then not used for 4 hours. A new cartridge was insert at the end of 4 hours. The 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 cartridges were being accounted for, as well as the number of patches. A Product Accountability (DA) domain was submitted to represent dispensed and returned amounts. Each cartridge had a uniquely assigned number. The sponsor used DAREFID that appeared on the label to identify the cartridge. 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. A returned cartridges that was not used was recorded as having weight of the dispensed cartridges,
NOTE ; A REAL EXAMPLE FROM A SPONOSR WOULD BE HELPFUL. THESE ARE MADE UP AMOUNTS. NEED TO ENSURE EXPOSURE NUMBERS MATCH THESE WEIGHTS:
da.xpt
xx.xpt
Row
STUDYID
DOMAIN
USUBJID
DASEQ
DAREFID
DATESTCD
DATEST
DACAT
DAORRES
DAORRESU
DASTRESC
DASTRESN
DASTRESU
DASTAT
DAREASND
VISITNUM
DADTC
1
ABC
DA
ABC-01001
1
CRT8754
DISPAMT
Dispensed Amount
STUDY PRODUCT
25
g
25
25
g
1
2004-06-26
2
ABC
DA
ABC-01001
2
CRT8768
DISPAMT
Dispensed Amount
STUDY PRODUCT
25
g
25
25
g
1
2004-06-26
3
ABC
DA
ABC-01001
3
CRT8769
DISPAMT
Dispensed Amount
STUDY PRODUCT
25
g
25
25
g
1
2004-06-26
4
ABC
DA
ABC-01001
4
CRT8754
RETAMT
Returned Amount
STUDY PRODUCT
NOT DONE
Subject forgot to return the cartridge
2020-07-06
5
ABC
DA
ABC-01001
5
CRT8768
RETAMT
Returned Amount
STUDY PRODUCT
24
g
24
24
g
2
2020-07-06
6
ABC
DA
ABC-01001
6
CRT8769
RETAMT
Returned Amount
STUDY PRODUCT
10
g
10
10
g
2
2020-07-06
7
ABC
DA
ABC-01001
7
CRT9756
DISPAMT
Dispensed Amount
STUDY PRODUCT
25
g
25
25
g
2
2020-07-06
8
ABC
DA
ABC-01001
8
CRT9756
RETAMT
Returned Amount
STUDY PRODUCT
14
g
14
143
g
3
2020-07-10
9
ABC
DA
ABC-01001
4
CRT8754
RETAMT
Returned Amount
STUDY PRODUCT
10
g
10
10
g
3
2020-07-06
Dataset Debug Message
There is a leading, trailing, or non-breaking space in the dataset.
EC was used to represent the collected exposure data since a double dummy design was used. The EX domain was used to represent the subject's exposure to the product containing nicotine.