This is an example of a clinical trial where the sponsor collected information on previous medically recognized products used to reduce nicotine dependency. These products are represented in the Concomitant Medication (CM) domain. These products are not represented in the SU domaiin. The sponsor assigned CMTRT to the name used in the WHO dictionary for these products.
| Panel |
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| title | PRODUCTS USED TO REDUCE NICOTINE DEPENDENCY |
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| Xformpusher |
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| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden | | CMCAT | 1 | What is the category of the substance used? |
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| Text | CMCAT |
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| DRUG USED IN NICOTINE DEPENDENCE |
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| | CMYN | 2 | Did the subject previously use any medically acceptable use products to reduce nicotine dependency? |
| Indicate if the subject had used any medically acceptable products to attempt to reduce nicotine dependency | Text | CMOCCUR | CMOCCUR where CMTRT= "DRUG PRODUCT USED IN NICOTINE DEPENDENCE" | (NY) | Yes; No |
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| | FAORRES | 3 | How many times did the subject attempt to use a medically acceptable products the product to reduce nicotine dependency | Times the Subject Attempted to Reduce Nicotine Dependency | Record the number of times a subject attempted to use a medically acceptable products product to reduce nicotine dependency | Text | FAORRES | FAORRES where FAOBJ ="DRUG PRODUCT USED IN NICOTINE DEPENDENCE" and FATEST= Total Number " |
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Record the information for the last attempt to to reduce nicotine dependency for each type of product used. | Xformpusher |
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| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden | | CMCAT | 1 | What is the category of the product used? |
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| CMCAT |
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| DRUG USED IN NICOTINE DEPENDENCE |
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| | CMSCAT | 3 | What is the type of product the subject used to attempt to reduce nicotine dependency? | Substance Use Category | Record the type of product the subject used to reduce nicotine dependency. | Text | CMSCAT |
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| NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; OTHER SMOKING CESSATION AIDS
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| | CMTRT | 4 | What was the name of the product the subject used to reduce nicotine dependency?
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| Text | CMTRT |
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| | CMDUR | 6 | What was the duration of the product usage to reduce nicotine dependency? | Duration | Provide the duration of the product used. | Text | CMDUR |
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| | CMCDURU | 7 | What was the duration unit of the product used to reduce nicotine dependency? | Unit | Select the appropriate duration unit of the product used. | Text | CMDURU |
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| DAYS; MONTHS; YEARS |
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