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 medically recognized products used to reduce nicotine dependency. These products are represented in the Concomitant Medication (CM) domain. These products are not represented in the SU domaiin. The sponsor assigned CMTRT to the name used in the WHO dictionary for these products.
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| title | aCRF: Product Used To Reduce Nicotine Dependency |
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| title | PRODUCTS USED TO REDUCE NICOTINE DEPENDENCY |
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Record the information for the last attempt to to reduce nicotine dependency for each type of product used.
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NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; OTHER SMOKING CESSATION AIDS
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This is the assoicated SDTM dataset.
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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 that were used by subjects. CMSCAT is used to indicate that these data are associated with the last attempted use. CMDUR is the collected | Rows 2-6: | Show the various 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. . 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 | 2 | NICOTINE PATCH XYZ | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION |
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| P2M | | 3 | 1234 | CM | 1234006 | 1 | 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 | | 5 | 1234 | CM | 1234006 | 3 | NICOTINE LOZENGES ABC | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION |
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| P2W | | 6 | 1234 | CM | 1234006 | 1 | BUPROPION | DRUG USED IN REDUCING NICOTINE DEPENDENCE 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 |
| | 8 | 1234 | CM | 1234007 | 3 | VARENICLINE | DRUG USED IN REDUCING NICOTINE DEPENDENCE 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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| NY | 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. Ony Only subjects , who had attempt attempted to reduce nicotine dependence , are included in the FACM dataset.
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