Drugs used in nicotine dependency are considered medically acceptable drugs and 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?Substance Use Category |
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| Text | CMCATSMOKING CESSATION PRODUCT |
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| DRUG USED IN NICOTINE DEPENDENCE |
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| | CMYN | 2 | Did Did the subject previously use any medically acceptable products to attempted attempted to quit smoking? |
| Indicate if the subject had used any medically acceptable products to attempted attempted to quit smoking. | Text | CMOCCUR | SUOCCUR CMOCCUR where SUTRT=Smoking Cessation ProductCMTRT= "Drug used in nicotine dependence" | (NY) | Yes; No |
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| | FAORRES | 3 | How many times did the subject attempt to quit smoking smoking using a a smocking cessation product? | Times the subject attempted to quit smoking times did the | Record the number of times a subject attempt to quit smoking smoking. | Text | FAORRES | FAORRES where FAOBJ ="SMOKING CESSATION PRODUCTDrug used in nicotine dependence" and FATEST= NUMBER OF ATTEMPTS TP QUIT" |
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RECORD THE INFORMATION FOR THE LAST ATTEMPT ATTEMPT TO QUIT FOR EACH TYPE OF PRODUCT USED COMBINATION OF METHODS SHOULD BE LISTED ON TEH SAME LINE ?????? This is a problem..
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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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| CMCATSMOKING CESSATION PRODUCT |
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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 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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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMSCAT | CMPRESP | CMOCCUR | CMDOSE | CMDOSU | CMDOSFRQ | CMSTDTC | CMENDTC | CMSTTPT | CMSTRTPT | CMENTPT | CMENRTPT |
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| 1 | 1234 | CM | 1234005 | 1 | SMOKING CESSATION PRODUCT | SMOKING CESSATION PRODUCT | DRUG USED IN NICOTINE DEPENDENCE |
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| Y | Y | 2 | PACK | QD |
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| 2006-01-01 | BEFORE | 2006-01-01 | ONGOING | | 2 | 1234 | CM | 1234005 | 2 | Nicotine patchSMOKING CESSATION PRODUCT | DRUG USED IN NICOTINE DEPENDENCE | NICOTINE REPLACEMENT THERAPY | Y | Y | 3 | CUP | QD | 2006-01-01 | 2006-01-01 |
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| | 3 | 1234 | CM | 1234006 | 1 | Nicotine gumSMOKING CESSATION PRODUCT | DRUG USED IN NICOTINE DEPENDENCE | NICOTINE REPLACEMENT THERAPY | Y | Y | 1 | PACK | QD |
| 2003 | 2006-03-15 | BEFORE |
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| | 4 | 1234 | CM | 1234006 | 2 | Nicotine lozenges:SMOKING CESSATION PRODUCT | 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 | bupropionSMOKING CESSATION PRODUCT | 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 | ChantixSMOKING CESSATION PRODUCT | 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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