The examples below illustrate various methods for displaying study product exposure data, as well as data that may be collected on the usage of other nicotine sources. These example illustrate the different ways that tobacco exposure may be imodelled based on how way the tobacco product is delivered.
The example below illustrate various methods for displaying study product exposure data, as well as data that may be collected on the usage of other nicotine sources.
In the following example, the sponsor reported protocol described usage of a nicotine inhaler using the EX and EC domains. Usage of non-protocol defined product usage (alcohol and other tobacco products) during the study were represented in the SU domain. Additionally, any usage of nicotine patches to reduce dependency on tobacco were reported in the CM domain. Study product exposure was represented as the number of cartridges used. The pharmaceutical strength of each cartridge was represented.
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| SDTM Example.Study Product Exposure and Other Reacrational Drug Use |
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| SDTM Example.Study Product Exposure and Other Reacrational Drug Use |
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In this example, the EC domain is not used by the sposnor to represent collected exposure. Expoure was represented based on the volume of the e-nicotine liquid cartridges.
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| SDTM Example.Nicotine Exposure ENDS |
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| SDTM Example.Nicotine Exposure ENDS |
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In this example, both the EC and EX domains are used. Exposure was based on the weight of the e-nicotine liquid cartridges.
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| SDTM Example.Nicotine Exposure Double-Dummy Design |
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| SDTM Example.Nicotine Exposure Double-Dummy Design |
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In this example, subjects were exposed to mulitple study products. The actual dates and times of use for each product is represented.
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| SDTM Example.Nicotine Exposure Crossover Design |
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| SDTM Example.Nicotine Exposure Crossover Design |
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