Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

In this study, subjects were randomized to an double blind study were subject were randomized to either nicotine replacement patches or ENDsENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devicedevices. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every Day day for 14 15 days. The nicotine patch was applied at the site every day , at rotating sites, . and the ENDS nicotine cartridge was replaced every day.   The cartridge was weight weighed when dispended 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 EC was used to represent the collected exposure data. 

...

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.    

Dataset wrap
Dataset2
RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDATESTCDDATESTDACATDASCATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TEDP07DA10001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.3g2525g12004-06-06
2TEDP07DA10001

2

CRT8754RETAMTReturned AmountSTUDY PRODUCTE-LIQUID23g2323g12020-06-06
3TEDP07DA10001

3

CRT9756DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.1g2525g12020-06-07
4TEDP07DA10001

4

CRT9756RETAMTReturned AmountSTUDY PRODUCTE-LIQUID10g1414g22020-06-08
5TEDP07DA10001

5

CRT9955DISPAMTDispensed AmountSTUDY PRODUCTE-LIQUID25.2g2525g22004-06-08

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.           

36
Dataset wrap
Nameec
ECVAMT
Dataset2

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSTXT

ECDOSU

ECDOSFRM

ECROUTE

ECVAMT

ECLOCECLATECDIREPOCH

ECSTDTC

ECENDTC

1
TENDS01
TEDP07EC10001 1ENDS  
1
10
CONTAINER

PUFF
INHALED36    
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-
27
01T08:002020-
07
06-
01
01T08:10
2
TENDS01
TEDP07EC10001 2

 PATCH 

1
PATCHPATCH
INHALED
TRANSDERMALARMRIGHTUPPERPRODUCT EXPOSURE2020-
07
06-012020-
07
06-
05
02
3
TENDS01
TEDP07EC10001 3ENDS 
5

AD LIBITUM
CONTAINER
PUFF
INHALED8mL
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-
07
06-
05
01T12:102020-
07
06-
10
02
4
TENDS01
TEDP07EC
10002
10001 
1
4
 PATCH 
ENDS  
7

AD LIBITUM
PATCH
PUFF
INHALED8
CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE
mL
2020-
09
06-
01
022020-
09
06-
07
03
5
TENDS01
TEDP07EC
10002 
10001
2
5
ENDS 
PATCH 1
CONTAINERINHALED8

PATCHPATCHTRANSDERMALARMLEFTUPPERPRODUCT EXPOSURE
mL
2020-
09
06-
07
022020-
09-146TENDS01EC10002 3 PATCH 1PATCHINHALED8mL2020-09-142020-09-217TENDS01EC10002 4ENDS 1CONTAINERINHALED8mL2020-09-212020-09-288TENDS01EC10002 5 PATCH 1PATCHINHALED8mL2020-09-282020-09-319TENDS01EC10002 6ENDS 1CONTAINERINHALED8mL2020-10-312020-10-0810TENDS01EC10002 7 PATCH 1PATCH INHALED8mL2020-10-082020-10-1511TENDS01EC10002 8ENDS 1CONTAINERINHALED8mL2020-10-15

2020-10-22

 PATCH 
06-03
6TEDP07EC100016ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-032020-06-04
7TEDP07EC100017PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTUPPERPRODUCT EXPOSURE2020-06-032020-06-04
7TEDP07EC10001 8ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-042020-06-05
8TEDP07EC10001 9PATCH 1
PATCHPATCHTRANSDERMALLEGLEFTLOWERPRODUCT EXPOSURE2020-06-042020-06-05
9TEDP07EC1000110ENDS 10
PUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-10T8:302020-06-10T8:40
10TEDP07EC1000111 PATCH 1
PATCH PATCH TRANSDERMALLEGRIGHTLOWERPRODUCT EXPOSURE2020-06-102020-06-11
11TEDP07EC1000112ENDS 
AD LIBITUMPUFFCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE2020-06-10T12:402020-06-11

 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.

Dataset wrap
Nameex
Dataset2

Row

STUDYID

DOMAIN

USUBJID

...

ECSEQ

...

ECTRT

...

ECDOSE

...

ECDOSU

...

ECROUTE

...

ECVAMT

...

ECVAMT

...

ECSTDTC

...

ECENDTC

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXDOSFRM

EXROUTE

EXLOCEXLATEXDIREPOCH

EXPSTRG

EXPSTRGU

EXSTDTC

EXENDTC

1TEDP07EX

...

10001 1e

...

nicotine liquid 1

...

.7gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%

...

2020-06-

...

01T08:002020-

...

06-01T:8:10
2

...

TEDP07

...

EX10001 2e

...

nicotine liquid 15.1

...

gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%

...

2020-

...

06-

...

01T12:102020-

...

06-

...

02
3

...

TEDP07

...

EX10001 3e

...

nicotine

...

liquid 13gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%

...

2020-

...

06-

...

022020-

...

06-

...

03
4

...

TEDP07

...

EX

...

10001

...

4e

...

nicotine liquid 

...

12gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%

...

2020-

...

06-

...

032020-

...

06-

...

04
5

...

TEDP07

...

EX

...

10001 

...

5e

...

nicotine liquid 9

...

gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%

...

2020-

...

06-

...

042020-

...

06-

...

05
6

...

TEDP07

...

EX

...

10001

...

6e

...

nicotine liquid 7g

...

CARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%

...

2020-

...

06-

...

10T08:302020-

...

06-

...

10T08:40
7

...

TEDP07

...

EX

...

10001

...

7e

...

nicotine liquid 5

...

gCARTRIDGERESPIRATORY (INHALATION)


PRODUCT EXPOSURE5%

...

2020-

...

06-

...

10T12:402020-

...

06-

...

11
8

...

TEDP07

...

EX

...

20001 

...

1

...

nicotine

...

replacement therapy

1

...

PATCHPATCHTRANSDERMALARMRIGHTUPPERPRODUCT EXPOSURE14mg

...

2020-

...

06-

...

012020-

...

06-

...

02
9

...

TEDP07

...

EX

...

20001

...

2

...

nicotine

...

replacement therapy1

...

PATCHPATCHTRANSDERMALARMLEFTUPPERPRODUCT EXPOSURE14mg

...

2020-

...

06-

...

022020-

...

06-

...

03
10

...

TEDP07

...

EX

...

20001

...

3

...

nicotine

...

replacement therapy1

...

PATCHPATCHTRANSDERMALLEGLEFTUPPERPRODUCT EXPOSURE14mg

...

2020-

...

06-

...

032020-

...

06-

...

04
11

...

TEDP07EX20001 4nicotine replacement therapy1PATCHPATCHTRANSDERMALLEGLEFTLOWERPRODUCT EXPOSURE14mg2020-06-042020-06-05
12TEDP07EX200015nicotine replacement therapy1PATCH PATCHTRANSDERMALLEGRIGHTLOWERPRODUCT EXPOSURE14mg2020-06-102020-06-11

...