Page History

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

SUTRT represents the

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.  

...

...

Smoked tobacco product;

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

...

brand name of the tobacco product

...

USUAL BRAND; 

NOT USUAL BRAND

...

. 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.          

In this situation, the sponsor maintained an in-house dictionary of tobacco brands. This allowed this sponsor to study products across studies using the same tobacco product code for each brand of tobacco product.  These codes were used to create a TO domain. This domain provided details on the brand of tobacco product used by the subject. Data for two brands of tobacco are shown. The additional information was represented as findings about events (FASU). For the general questions about tobacco usage, the applicant assigned FAOBJ to "TOBACCO".  Otherwise, the name of the tobacco product (SUTRT) associated with the data in the row was represented in FAOBJ. The UPC code was used by the applicant to identify the product. FADTC is the date of collection, in this situation the applicant used the visit date.