An example of the SDTM 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 VareniclineSince this was pre-specified on the CRF, CMPRESP=Y. 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 these data are 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. CMPRESP is null since the specific medication used is not pre-specified. |
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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 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 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 | | 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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