This is an example of a clinical trial where the sponsor collected information on previous medically acceptable 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.
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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 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 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 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 to reduce nicotine dependency | Text | FAORRES | FAORRES where FAOBJ ="DRUG 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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