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.
| Panel |
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| title | SMOKING CESSATION PRODUCT |
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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? | 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.
| 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? | 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 | CMDUR | 6 | What was the duration of the product usage to quit smoking? | Duration | Provide the duration of the substance use | Text | CMDUR | 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 | CMDURU | DAYS; MONTHS; YEARS | Prompt | | Dataset wrap |
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| Rowcaps |
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| Rows 1, 3, 7, 9: | Show | Row 1: | Shows whether the subject has used any products medications to help with nicotine dependence. These include nicotine replacement therapies and 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. 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 | Rows 2-6: | Show the various smoking cessation products products that were used by subjects. CMSCAT is used to indicate that these data are associated with the last attempted use. CMDUR is the collected 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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| 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 | 2Nicotine patch | NICOTINE PATCH XYZ | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION |
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| P2M | | 3 | 1234 | CM | 1234006 | 1Nicotine gum | DRUG USED IN NICOTINE DEPENDENCE |
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| Y | Y | 2008-11-12 |
| | 4 | 1234 | CM | 1234006 | 2 | NICOTINE GUM ABC | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION |
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| P3M | | 45 | 1234 | CM | 1234006 | 2 | 3 | NICOTINE LOZENGES ABCNicotine lozenges | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION |
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| P2W | | 56 | 1234 | CM | 1234006 | 31 | Bupropion | BUPROPION | DRUG USED IN REDUCING NICOTINE DEPENDENCE SMOKING CESSATION PHARMCEUTICALS OTHER THAN NRTS | LAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION |
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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 | Varenicline | VARENICLINE | DRUG USED IN REDUCING NICOTINE DEPENDENCE SMOKING CESSATION PHARMCEUTICALS OTHER THAN NRTS | LAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION |
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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 attempt to quit smoking attempted to reduce nicotine dependency using a medically acceptable smoking cessation product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.
| 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 | ABC1234 | FA | ABC-1231234005 | 1 | TOTNUMNUMBER | Total Number | DRUG USED IN NICOTINE DEPENDENCE | TOBACCO CESSATION 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 | 2008-06-122007-05-16 |
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