Drugs used in nicotine dependency 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 drugs and were were represented in the Concomitant Medication (CM) domain.
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Modelling of this information needs discussion at ISMT.
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| title | SMOKING CESSATION PRODUCT |
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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 smoking? |
| Indicate if the subject had used any medically acceptable products to attempted to quit smoking | 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 quit smoking using a smocking cessation product? | Times the subject attempted to quit smoking | Record the number of times a subject attempt to quit smoking. | Text | FAORRES | FAORRES where FAOBJ ="Drug used in nicotine dependence" and FATEST= NUMBER OF ATTEMPTS TP QUIT" |
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RECORD THE INFORMATION FOR THE LAST ATTEMPT TO QUIT FOR EACH TYPE OF PRODUCT USED CUSED. COMBINATION USE OF PRODUCTSOMBINATION OF METHODS SHOULD BE LISTED ON TEH SAME LINE ?????? This is a problem.. | 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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| CMCAT |
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| DRUG DRUG USED IN NICOTINE DEPENDENCE |
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| | CMSCAT | 3 | What is the type of product the subject used to attempted to quit smoking? | Substance Use Category | Record the type of product the subject used to attempted to quit smoking. | 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 name of the product the subject used to attempted to quit smoking?
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| Text | CMTRT |
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| | CMDSTXT | 5 | What was the amount of product used to quit smoking? | Amount | Indicate the amount of amount of tobacco product used to quit smoking? | Text | CMDOSE; CMDOSTXT |
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| | CMDUR | 6 | What was the duration of the product usage to quit smoking? | Duration | Provide the duration of the substance use | Text | CMDOSFRQ |
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| | CMCDURU | 7 | What was the duration unit of the product used to quit smoking? | Unit | Select the appropriate duration unit of the tobacco product used | Text | CMDUR |
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| DAYS; MONTHS; YEARS |
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| CMDOSFRQ | 8 | What was the frequency of of the product used to quit smoking | Frequency |
| Text | CMDOSFRQ |
| (FREQ) | QD; EVERY WEEK; QM; PA |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMSCAT | CMPRESP | CMOCCUR | CMDOSE | CMDOSU | CMDOSFRQ | CMDOSFRM | CMSTDTC | CMENDTC | CMSTTPT | CMSTRTPT | CMENTPT | CMENRTPT |
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| 1 | 1234 | CM | 1234005 | 1 | DRUG USED IN NICOTINE DEPENDENCE |
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| Y | Y |
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| 2006-01-01 | BEFORE | 2006-01-01 | ONGOING | | 2 | 1234 | CM | 1234005 | 2 | Nicotine patch | DRUG USED IN NICOTINE DEPENDENCE | NICOTINE REPLACEMENT THERAPY | Y | Y | 314 | CUPPATCH | QD | PATCH | 2006-01-01 | 2006-01-01 |
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| | 3 | 1234 | CM | 1234006 | 1 | Nicotine gum | DRUG USED IN NICOTINE DEPENDENCE | NICOTINE REPLACEMENT THERAPY | Y | Y | 1 | PACK | QD |
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| 2003 | 2006-03-15 | BEFORE |
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| | 4 | 1234 | CM | 1234006 | 2 | Nicotine lozenges: | DRUG USED IN NICOTINE DEPENDENCE | NICOTINE REPLACEMENT THERAPY | Y | Y | 1 | CUP | QD |
| 2006-03-15 | 2006-03-15 |
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| | 5 | 1234 | CM | 1234006 | 3 | bupropion | DRUG USED IN NICOTINE DEPENDENCE | Pharmaceuticals
other than NRTs | Y | Y | 2 | CUP | QD |
| 2006-03-15 | 2006-03-15 |
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| | 6 | 1234 | CM | 1234007 | 1 | Chantix | DRUG USED IN NICOTINE DEPENDENCE | Pharmaceuticals
other than NRTs | Y |
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| Row | STUDYID | DOMAIN | USUBJID | FASEQ | FASPID | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FASTRESC | FADTC | FATPT | FATPTNUM | FAELTM | FATPTREF |
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| 1 | ABC | FA | ABC-123 | 1 | 90567 |
| NUMBER | NRT | TOBACCO CESSATION ATTEMPTS | 10 | 10 | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | | 2 | ABC | FA | ABC-123 | 2 | 90567 | OCCUR | AGE STARTED SMOKING ( Or Tobacco Product) DAILY |
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| 16 | 16 | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | | 3 | ABC | FA | ABC-123 | 3 | 90567 | OCCUR | NUMBER | PHARMACUETIAL | TOBACCO CESSATION ATTEMPTS | N | N | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | | 4 | ABC | FA | ABC-123 | 4 | 90567 | OCCUR | Occurrence Indicator |
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| Y | Y | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | | 5 | ABC | FA | ABC-123 | | 90567 | OCCUR | Occurrence Indicator |
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| Y | Y | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | |
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