Versions Compared

Key

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

The example SDTM datasets used to represent the collected data are shown below. 

SUTRT represents

This example illustrates how typical tobacco use history data could be collected. This example only includes tobacco products that are not being used as a medically acceptable therapies for smoke cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco strips. Usage of these products are represented in the SU domain.  

...

titleTobacco Usage History

...

titleTobacco Product Used

For each Tobacco product used, Complete the following.   

...

Smoked tobacco product;

Smokeless tobacco (e.g., chewing tobacco, snuff, dip, snus, or dissolvable tobacco) product 

...

the brand name of the tobacco product

...

USUAL BRAND; 

NOT USUAL BRAND

...

This is an example SDTM dataset used to represent the data. SUTRT captures the verbatim or the prespecified text collected for the substance, in this case the brand name of the tobacco product.. The applicant added the UPC code of the product to the dataset. Some applicants may collect the UPC code on the CRF. The duration was represented using ISO 8601 duration format. The applicant used the first visit date to populate SUSTPT and SUENTPT.          

Dataset wrap
NameSU
Rowcaps
Row 1: Shows that the subject used  this used the tobacco product shown in SUTRT. SUCAT and SUSCAT categorize the product used. The dates of use were not know, but SUSTTPT, SUSTRTPT,  SUENTPT SUENTPT and  SUENRTPT SUENRTPT indicate that the use started before the visit and  and was still ongoing,  
Row 2:Shows that the subject used  this used smokeless tobacco product shown in SUTRT. This was not the subject's usual brand of  of smokeless tobacco product.  
Dataset2
tableidSU
Y

Row

STUDYID

DOMAIN

USUBJID

SUSEQ

SUTRT

SUCAT

SUSCAT

SUOCCUR

SUPREP

SUDOSE

SUDOSU

SUDOSFRQ

SUSTDTC

SUENDTC

SUDUR

SUENDTCSUSTTPT

SUSTRTPT

SUENTPTSUSTTPT

SUENRTPT

TB901SUTB9010051TOBACCO TOBACCOY

SUENTPT

1TB901SUTB90100521XYZ Menthol King SizeSMOKED TOBACCO PRODUCTUSUAL BRAND2P20YPACK
QDBEFORE2006-01-01BEFOREONGOING2006-01-01ONGOING
2TB901SUTB90100632AAA Chewing TobaccoSMOKELESS TOBACCO PRODUCTNOT USUAL BRAND1CANEVERY WEEKP3M2006-01-01BEFORE2002 2006-01-01

The additional information was represented as findings about events (FASU). The For the general questions about tobacco usage, the applicant assigned FAOBJ to "TOBACCO".  Otherwise, the name of the treatment tobacco product (SUTRT) associated with the data in the row was represented n in FAOBJ. The UPC code was used by the sponsor applicant to identify the product. FADTC is the date of collection, in this situation the applicant used the visit date.  

Dataset wrap
NameFASU
Dataset2
tableidSU
RowSTUDYIDDOMAINUSUBJIDFASEQUSUBJIDFATESTCDFATESTFAOBJFAORRESFAORRESUFASTRESCFASTRESNFASTRESUVISITNUMFADTC
1TB901FATB901005

1

TB901005

AGESTSMKAge Started SmokingTOBACCO1416-24Years141416-24
Years120222006-701-1301
2TB901FATB901005

2

TB901005

TBCESSCOTobacco Cessation CounselingTOBACCON
N

120222006-701-1301
3TB901FATB901005

3

TB901005

LDURABSLongest Duration of AbstinenceTOBACCO>6 months
>6 months

120222006-701-1301
54TB901FATB9010054TB901005UPCCODEUPC CodeXYZ Menthol King Size974411001532
974411001532974411001532
120222006-701-13017
5TB901FATB9010055TB901005UPCCODEUPC CodeAAA Chewing Tobacco974411001532
974411001532974411001532
120222006-701-1301