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  • The Findings About Events or Interventions (FA–)  is a specialization of the Findings general observation class. it shares all qualities and conventions of Findings observations but is specialized by the addition of the --OBJ variable. 
Example

This example collects data on all types of recreational products previosuly used by the subject. The sponsor only collected the general type of product used. The actual dates of usage were also not collected. The subject provided the duration of use. Usage of these recreational products are represented in the SU domain.  

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CDASH Example.Recreational Products Used
CDASH Example.Recreational Products Used

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SDTM Example.Recreational Product Use
SDTM Example.Recreational Product Use

In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The sponsor only collected details on the last attempt to reduce nicotine dependency for each type of product used. These products are represented in the Concomitant Medication (CM) domain.

Example

This example illustrates how tobacco use history data could be collected. This example does not include  tobacco products that are  being used as a medically acceptable therapy for smoking cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco dips. The specific brand name of the product was collected. The sponsor collected whether the product was still being used, and if not, the end date of usage. Usage of these products is represented in the SU domain.  

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CDASH Example.Tobacco Product Use History
CDASH Example.Tobacco Product Use History

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SDTM Example.Tobacco Product Use History
SDTM Example.Tobacco Product Use History

Example
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CDASH Example.Medications Used for Nicotine DependencyCDASH Example.Medications Used for Nicotine Dependency
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SDTM Example.Products Used for Nicotine DependencySDTM Example.Products Used for Nicotine Dependency
Example

This example is an additional example of data collected on the previous use of smoking cessation products at the baseline visit.  This example illustrates the use of CMOCCUR and CMPRESP. The reason why a product was discontinued and any use in the last 14 days was of interest.  

 

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CDASH Example.Products Used For Smoking CessationCDASH Example.Products Used For Smoking Cessation
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SDTM Example.Products Used for Smoking CessationSDTM Example.Products Used for Smoking Cessation


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