You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 5 Next »

EAM DISCUSSION

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. 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

RowSTUDYIDDOMAINUSUBJIDDASEQDAREFIDDATESTCDDATESTDACATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUDASTATDAREASNDVISITNUMDADTC
1ABCDAABC-01001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCT25g2525g

12004-06-26
2ABCDAABC-01001

2

CRT8768DISPAMTDispensed AmountSTUDY PRODUCT25g2525g

12004-06-26
3ABCDAABC-01001

3

CRT8769DISPAMTDispensed AmountSTUDY PRODUCT25g2525g

12004-06-26
4ABCDAABC-01001

4

CRT8754RETAMTReturned AmountSTUDY PRODUCT




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

5

CRT8768RETAMTReturned AmountSTUDY PRODUCT24g2424g

22020-07-06
6ABCDAABC-01001

6

CRT8769RETAMTReturned AmountSTUDY PRODUCT10g1010g

22020-07-06
7ABCDAABC-01001

7

CRT9756DISPAMTDispensed AmountSTUDY PRODUCT25g 2525g

22020-07-06
8ABCDAABC-01001

8

CRT9756RETAMTReturned AmountSTUDY PRODUCT14g14143g

32020-07-10
9ABCDAABC-01001

4

CRT8754RETAMTReturned AmountSTUDY PRODUCT10g1010g

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).

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.      




$titleHtml

ec.xpt

Row

STUDYID

DOMAIN

USUBJID

ECSEQ

ECTRT

ECDOSE

ECDOSU

ECROUTE

ECFREQECLOCECLATECDIREPOCH

ECSTDTC

ECENDTC

1TEDP07EC10001 1ENDS  1CONTAINERINHALEDONCE


TREATMENT2020-06-01T8:002020-06-01T:8:10
2TEDP07EC10001 2

 PATCH 

1PATCHTRANSDERMAL
ARMRIGHTUPPERTREATMENT2020-06-012020-06-02
3TEDP07EC10001 3ENDS 1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-01:T12:102020-06-02
4TEDP07EC10001 1ENDS  1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-022020-06-02
5TEDP07EC100011 PATCH 1PATCHTRANSDERMAL
ARMLEFTUPPERTREATMENT2020-06-022020-06-03
6TEDP07EC100012ENDS 1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-032020-06-03
7TEDP07EC100013 PATCH 1PATCHTRANSDERMAL
LEGLEFTUPPERTREATMENT2020-06-032020-06-04
7TEDP07EC10001 4ENDS 1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-042020-06-05
8TEDP07EC10001 5 PATCH 1PATCHTRANSDERMAL
LEGLEFTLOWERTREATMENT2020-06-042020-06-05
9TEDP07EC100016ENDS 1CONTAINERINHALEDONCE


TREATMENT2020-06-T09;8:302020-06-T09;8:40
10TEDP07EC100017 PATCH 1PATCH TRANSDERMAL
LEGRIGHTLOWERTREATMENT2020-06-102020-06-11
11TEDP07EC100018ENDS 1CONTAINERINHALEDAD LIBITUM


TREATMENT2020-06-10:T12:402020-06-11
$warningHtml
TIME FORMATS NEED TO BE FIXED 
$titleHtml

ex.xpt

Row

STUDYID

DOMAIN

USUBJID

EXSEQ

EXTRT

EXDOSE

EXDOSU

EXROUTE

EXFREQEXLOCEXLATEXDIREPOCH

EXPSTRG

EXPSTRGU

ECSTDTC

ECENDTC

1TEDP07EX10001 1ENDS  3gINHALEDONCE


TREATMENT5%2020-06-01:T8:002020-06-01:8:10
2TEDP07EX10001 2ENDS 15gINHALEDAD LIBITUM


TRE5ATMENT5%2020-06-01:T8:102020-06-02
3TEDP07EX10001 3ENDS  13gINHALEDAD LIBITUM


TREATMENT

2020-06-022020-06-02
4TEDP07EX100014ENDS 12gINHALEDAD LIBITUM


TREATMENT

2020-06-032020-06-03
5TEDP07EX10001 5ENDS 9gINHALEDAD LIBITUM


TREATMENT

2020-06-042020-06-05
6TEDP07EX100016ENDS 7gINHALEDONCE


TREATMENT

2020-06-09T8:302020-06-09T8:40
7TEDP07EX100017ENDS 5mgINHALEDAD LIBITUM


TREATMENT

2020-06-10T::2402020-06-11
8TEDP07EC10001 1

 PATCH 

1PATCHTRANSDERMALQDARMRIGHTUPPERTREATMENT14mg2020-06-012020-06-02
9TEDP07EC200012 PATCH 1PATCHTRANSDERMALQDARMLEFTUPPERTREATMENT14mg2020-06-022020-06-03
10TEDP07EC200013 PATCH 1PATCHTRANSDERMALQDLEGLEFTUPPERTREATMENT14mg2020-06-032020-06-04
11TEDP07EC20001 4 PATCH 1PATCHTRANSDERMALQDLEGLEFTLOWERTREATMENT14mg2020-06-042020-06-05
12TEDP07EC200017 PATCH 1PATCH TRANSDERMALQDLEGRIGHTLOWERTREATMENT14mg2020-06-102020-06-11
$warningHtml


  • No labels