This is an example of a clinical trial where the sponsor collected information on previous products used to reduce nicotine dependency. These products are considered medically acceptable drugs and were represented in the Concomitant Medication (CM) domain.
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| title | SMOKING CESSATION PRODUCT 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 attempted to quit smokingreduce nicotine dependency? |
| Indicate if the subject had used any medically acceptable products to attempted to quit smokingattempt to reduce nicotine dependency | Text | CMOCCUR | CMOCCUR where CMTRT= "Drug used in nicotine dependenceDRUG USED IN NICOTINE DEPENDENCE" | (NY) | Yes; No |
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| | FAORRES | 3 | How many times did the subject attempt to quit smoking using a smocking cessation product? reduce nicotine dependency? | Times the subject attempted to quit smoking Subject Attempted to Reduce Nicotine Dependency | Record the number of times a subject attempt to quit smoking. attempted to reduce nicotine dependency | Text | FAORRES | FAORRES where FAOBJ ="Drug used in nicotine dependence" DRUG USED IN NICOTINE DEPENDENCE" and FATEST= NUMBER OF ATTEMPTS TP TO QUIT" |
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Record the information for the last attempt to to quit 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 substance 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 attempted to quit smokingattempt to reduce nicotine dependency? | Substance Use Category | Record the type of product the subject used to attempted to quit smoking. reduce nicotine dependency. | Text | CMSCAT |
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| Nicotine Replacement
Therapy (NRT); Pharmaceuticals
other than NRTs; Other
Smoking Cessation aids
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| | CMTRT | 4 | What was the the name of the product the subject used to attempted to quit smoking reduce nicotine dependency?
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| Text | CMTRT |
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| | CMDUR | 6 | What was the duration of the product usage to quit smoking reduce nicotine dependency? | Duration | Provide the duration of the substance use product used | Text | CMDUR |
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| Prompt |
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| | CMCDURU | 7 | What was the duration unit of the product used to quit smoking reduce nicotine dependency? | Unit | Select the appropriate duration unit of the tobacco the product used. | Text | CMDURU |
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| DAYS; MONTHS; YEARS |
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| Dataset wrap |
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| Row 1: | Shows whether the subject has used any products to help with nicotine dependence. These include nicotine replacement therapies and pharmaceuticals pharmaceuticals drugs like Varenicline. The sponsor assigned CMTRT to the name used in the WHO dictionary for these products. CMDTC is the date this assessment was made. | | Rows 2-6: | Show the various smoking cessation products products that were used by subjects. CMDUR is the collected duration of the product use. This is used only if collected on the CRF and not derived from start and end date/times. CMDUR is provided using ISO 8601 duration notation. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMSCAT | CMPRESP | CMOCCUR | CMDTC | CMDUR |
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| 1 | 1234 | CM | 1234005 | 1 | DRUG USED IN NICOTINE DEPENDENCE |
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| Y | Y | 2008-08-08 |
| | 2 | 1234 | CM | 1234005 | 2 | Nicotine patch | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPT WITH THIS PRODUCT |
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| P2M | | 3 | 1234 | CM | 1234006 | 1 | Nicotine gum | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPT WITH THIS PRODUCT |
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| P3M | | 4 | 1234 | CM | 1234006 | 2 | Nicotine lozenges | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPT WITH THIS PRODUCT |
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| P2W | | 5 | 1234 | CM | 1234006 | 3 | Bupropion | SMOKING CESSATION PHARMCEUTICALS DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS | LAST ATTEMPT WITH THIS PRODUCT |
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| P1M | | 6 | 1234 | CM | 1234007 | 1 | Varenicline | SMOKING CESSATION PHARMCEUTICALS DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS | LAST ATTEMPT WITH THIS PRODUCT |
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| P40D |
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FACM was used to represent the total number of times the subject attempt to quit smoking attempted to reduce nicotine dependency using a medically acceptable smoking cessation product.
| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | FASEQ | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FASTRESC | FADTC |
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| 1 | ABC | FA | ABC-123 | 1 |
| NUMBER | DRUG USED IN NICOTINE DEPENDENCE | TOBACCO CESSATION ATTEMPTS TO REDUCE NICOTINE DEPENDENCE | 4 | 4 | 2007-05-16 |
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