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Data Concomitant Medication (CM) is an Interventions domain is used to represent information relating to concomitant and prior medications used by the subject, such as those given on an as-needed basis or condition-appropriate medications are collected. The same basic data collection variables should be collected for all medications, treatments, and therapies (prior, general concomitant medications, and medications of interest). Reacreational Recreational substances are not represented in this domain . However, medical proudcts (see Section 3.3.2.7, Prior Usage of Recreational Products (Including Tobacco Products) (SU, FASU, CM, FACM)), but rather medical products recognized to reduce nicotine dependence would be represented in this domain (e.g., Nicotine replacemnet nicotine replacement patches).   

Example

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CDASH Example.Concomitant Medications-General
CDASH Example.Concomitant Medications-General
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SDTM Example.Concomitant Medication
SDTM Example.Concomitant Medication

Example

In this example, the applicant collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The applicant 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.

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CDASH Example.Medications Used for Nicotine Dependency
CDASH Example.Medications Used for Nicotine Dependency

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SDTM Example.Products Used for Nicotine Dependency
SDTM Example.Products Used for Nicotine Dependency

ADaM Example.ADCM Concomitant Medication
Example
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ADaM Example.ADCM Concomitant Medication

In this example, data were 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 Cessation
CDASH Example.Products Used For Smoking Cessation

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SDTM Example.Products Used for Smoking Cessation
SDTM Example.Products Used for Smoking Cessation

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