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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

RowSTUDYIDDOMAINUSUBJIDSUSEQSUTRTSUCATSUDOSESUDOSUSUDOSFRQSUSTDTCSUENDTC
1TENDS01SUABC-010011CIGARETTESTOBACCO6CIGARETTEPER DAY2020-06-272020-06-27
2TENDS01SUABC-010011CIGARETTESTOBACCO1CIGARETTEPER DAY2020-06-282020-06-28
3TENDS01SUABC-010011CIGARETTESTOBACCO0CIGARETTEPER DAY2020-06-292020-06-29
$warningHtml

In this study,  the volume of the contents in the cartridges were being accounted for.  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 the full volume returned.    

da.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDATESTCDDATESTDACATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUDASTATDAREASNDVISITNUMDADTC
1ABCDAABC-01001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCT8mL88mL

12004-06-26
2ABCDAABC-01001

2

CRT8768DISPAMTDispensed AmountSTUDY PRODUCT8mL88mL

12004-06-26
3ABCDAABC-01001

3

CRT8769DISPAMTDispensed AmountSTUDY PRODUCT8mL88mL

12004-06-26
4ABCDAABC-01001

4

CRT8754RETAMTReturned AmountSTUDY PRODUCT




NOT DONESubject forgot to return the cartridge
2020-07-06
5ABCDAABC-01001

5

CRT8768RETAMTReturned AmountSTUDY PRODUCT1.6mL88mL

22020-07-06
6ABCDAABC-01001

6

CRT8769RETAMTReturned AmountSTUDY PRODUCT8mL88mL

22020-07-06
7ABCDAABC-01001

7

CRT9756DISPAMTDispensed AmountSTUDY PRODUCT8mL 88mL

22020-07-06
8ABCDAABC-01001

8

CRT9756RETAMTReturned AmountSTUDY PRODUCT1.0mL1.31.3mL

32020-07-10
9ABCDAABC-01001

4

CRT8754RETAMTReturned AmountSTUDY PRODUCT2mL66mL

32020-07-06

Dataset Debug Messages

  • There is a leading, trailing, or non-breaking space in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

 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

RowSTUDYIDDOMAINUSUBJIDEXSEQEXREFIDEXTRTEXDOSEEXDOSUEXROUTEEXPSTRGEXPSTRGEXSTDTCEXENDTC
1TENDS01EX10001 1CRT8754e-liquid 6mLINHALED8mg/mL2020-06-262020-07-01
2TENDS01EC10001 2CRT8768e-liquid 6.7mLINHALED8mg/mL2020-07-012020-07-06
3TENDS01EC10001 3CRT9756e-liquid 7mLINHALED8mg/mL2020-07-062020-07-10
3TENDS01EC10001 4CRT9778e-liquid 8mLINHALED8mg/mL2020-07-102020-07-14
4TENDS01EC100025CRT8000e-liquid 5mLINHALED36mg/mL2020-09-012020-09-07
5TENDS01EC10002 6CRT9006e-liquid 7mLINHALED36mg/mL2020-09-072020-09-14
6TENDS01EC10002 7CRT9008e-liquid 8mLINHALED36mg/mL2020-09-142020-09-21
7TENDS01EC10002 8CRT9017e-liquid 6mLINHALED36mg/mL2020-09-212020-09-28
8TENDS01EC10002 9CRT9089e-liquid 7mLINHALED36mg/mL2020-09-282020-09-31
9TENDS01EC10002 10CRT9128e-liquid 8mLINHALED36mg/mL2020-10-312020-10-08
10TENDS01EC10002 1CRT6868e-liquid 6.7mLINHALED36mg/mL2020-10-082020-10-15
11TENDS01EC10002 2CRT7868e-liquid 5.5mLINHALED36mg/mL2020-10-152020-10-22

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.
  • Please remove all formatting (see How to Clear Formatting).

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