This is an An example of an the SDTM dataset datasets used to represent the data collected on the above CRF . are provided below:
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Rows 1,3,7,9: | Show whether the subject has used any medications to help with nicotine dependence. These include nicotine replacement therapies and pharmaceuticals drugs like Varenicline. The sponsor assigned CMTRT to "DRUG USED IN NICOTINE DEPENDENCE" which was the category name in an external dictionary. | Rows 2,4,5,6: | Show the various medications that were used by subjects. CMSCAT is used to indicate that this data is associated with the LAST ATTEMPTED USE WITH THIS MEDICATION. 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. |
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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 | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPTED USE WITH THIS MEDICATION |
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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 | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P3M | 5 | 1234 | CM | 1234006 | 3 | NICOTINE LOZENGES | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPTED USE WITH THIS MEDICATION |
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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 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 |
| 8 | 1234 | CM | 1234007 | 3 | VARENICLINE | DRUG USED IN REDUCING NICOTINE DEPENDENCE 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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