These example SDTM datasets represent the data collected on the above CRF.
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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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? | Text | CMCAT | DRUG USED IN NICOTINE DEPENDENCE | 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 | 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" | RECORD THE INFORMATION FOR THE LAST ATTEMPT TO QUIT FOR EACH TYPE OF PRODUCT USED.
COMBINATION USE OF PRODUCTS???
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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? | CMCAT | DRUG USED IN NICOTINE DEPENDENCE | 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 | Nicotine Replacement
Therapy (NRT);
Pharmaceuticals
other than NRTs;
Other
Smoking Cessation aids
CMTRT | 4 | What was the name of the product the subject used to attempted to quit smoking?
Text | CMTRT | 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 | Prompt | CMDUR | 6 | What was the duration of the product usage to quit smoking? | Duration | Provide the duration of the substance use | Text | CMDOSFRQ | Prompt | 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 | DAYS; MONTHS; YEARS | Prompt | CMDOSFRQ | 8 | What was the frequency of of the product used to quit smoking | Frequency | Text | CMDOSFRQ | (FREQ) | QD; EVERY WEEK; QM; PA | Prompt | Dataset wrap |
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Rows 1, 3, 7, 9: | Show whether the subject has used any medications to help with nicotine dependence. This was prespecified on the CRF, hence CMPRESP="Y". The applicant assigned CMTRT to "DRUG USED IN NICOTINE DEPENDENCE" which was the category name in an external dictionary. | Rows 2, 4, 5, 6, 8: | Show the various medications that were used by subjects. CMSCAT is used to indicate that these data are associated with the last attempted use. 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. CMPRESP is null since the specific medication used is not prespecified. |
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Row 1: | | Row 2: | Row 3: | Row 4: | Row 5: | Row 6: | Row 7: | Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMSCAT | CMPRESP | CMOCCUR | CMDOSECMDTC | CMDOSU | CMDOSFRQ | CMDOSFRM | CMSTDTC | CMENDTC | CMSTTPT | CMSTRTPT | CMENTPT | CMENRTPT | CMDUR |
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1 | 1234 | CM | 1234005 | 1 | DRUG DRUG USED IN IN NICOTINE DEPENDENCE DEPENDENCE |
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| Y | Y | 20062008-01-01 | BEFORE | 2006-01-01 | ONGOING08-08 |
| 2 | 1234 | CM | 1234005 | 2 | Nicotine patch | DRUG USED IN NICOTINE DEPENDENCE | NICOTINE REPLACEMENT THERAPY | Y | Y | 14 | PATCH | QD | PATCH | 2006-01-01 | NICOTINE PATCH XYZ | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P2M2006-01-01 | 3 | 1234 | CM | 1234006 | 1 | Nicotine gum | DRUG USED IN DRUG USED IN NICOTINE DEPENDENCE | NICOTINE REPLACEMENT THERAPY |
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| Y | Y | 1 | PACK | QD | 2003 | 2006-03-15 | BEFORE | 2008-11-12 |
| 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 | NICOTINE GUM ABC | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P3M | 5 | 1234 | CM | 1234006 | 3 | NICOTINE LOZENGES ABC | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P2W | 65 | 1234 | CM | 1234006 | 31 | bupropionBUPROPION | DRUG DRUG USED IN IN REDUCING NICOTINE DEPENDENCE | Pharmaceuticals other than NRTs | Y | Y | 2 | CUP | QD | 2006-03-15 | 2006-03-15 | OTHER THAN NRTS | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P1M | 7 | 1234 | CM | 1234007 | 2 | DRUG USED IN NICOTINE DEPENDENCE |
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| Y | Y | 2008-06-12 |
| 86 | 1234 | CM | 1234007 | 13 | ChantixVARENICLINE | DRUG DRUG USED IN IN REDUCING NICOTINE DEPENDENCE | Pharmaceuticals other than NRTs | Y | OTHER THAN NRTS | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P40D | 9 | 1234 | CM | 1234012 | 1 | DRUG USED IN NICOTINE DEPENDENCE |
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| Y | N | 2008-03-05 |
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FACM was used to represent the total number of times the subject attempted to reduce nicotine dependency using a medically acceptable product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.
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Rows 1, 6, 11: | Rows 2-5, 7-10, 12-15: |
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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 | ABC1234 | FA | ABC-1231234005 | 1 | 90567TOTNUM | 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 | 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 | Total Number | DRUG USED IN NICOTINE DEPENDENCE | ATTEMPTS TO REDUCE NICOTINE DEPENDENCE | 4 | 4 | 2008-08-08 | 2 | 1234 | FA | 1234006 | 1 | TOTNUM | Total Number | DRUG USED IN NICOTINE DEPENDENCE | ATTEMPTS TO REDUCE NICOTINE DEPENDENCE | 5 | 5 | 2008-11-12 | 3 | 1234 | FA | 1234007 | 1 | TOTNUM | Total Number | DRUG USED IN NICOTINE DEPENDENCE | ATTEMPTS TO REDUCE NICOTINE DEPENDENCE | 3 | 3 | 2008-06-12 | 4 | ABC | FA | ABC-123 | 4 | 90567 | OCCUR | Occurrence Indicator | Y | Y | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | 5 | ABC | FA | ABC-123 | | 90567 | OCCUR | Occurrence Indicator | Y | Y | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING |
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