This is an These example of an SDTM dataset used to datasets represent the data collected on the above CRF.
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| Row Rows 1, 3, 7, 9: | Shows Show 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 CRF. 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 products medications that were used by subjects. CMSCAT is used to indicate that this these data is are associated with the LAST ATTEMPT USE WITH THIS PRODUCTlast 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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| 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 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 ATTEMPTED USE WITH THIS PRODUCTMEDICATION |
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| P3M | | 5 | 1234 | CM | 1234006 | 3 | NICOTINE LOZENGES ABC | NICOTINE REPLACEMENT THERAPY | LAST 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 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 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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