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This is an example of a study where the sponsor collected issues and events associated with the operation of the electronic cigarette device product and any adverse events that a subject experienced as a result of the product issue or event.   

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The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TO) domain which provides a mechanism for uniquely identifying a tobacco product was used.  Only one tobacco product was of interest in the study. 

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These product issues and events are represented in the Product Issues and Events Domain (PI).  Events not specifically associated with the device product should not be represented in this PI domain.     

The sponsor used a standardized or dictionary-derived text for the description of an issue or events. CDISC does not provide information on what standardized or dictionary-derived text should be used (if any) . 

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The PI dataset is shown below;. 

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IN In this study, subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown below  for brevity.  

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