This is an example of an SDTM dataset used to represent the data collected on the above CRF.
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Row 1: | Shows whether the subject has used any products 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. | 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. |
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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 ATTEMPT WITH THIS PRODUCT |
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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 ATTEMPT WITH THIS PRODUCT |
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| P3M | 5 | 1234 | CM | 1234006 | 3 | NICOTINE LOZENGES | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPT WITH THIS PRODUCT |
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| P2W | 6 | 1234 | CM | 1234006 | 1 | BUPROPION | DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS | LAST ATTEMPT WITH THIS PRODUCT |
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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 WITH THIS PRODUCT |
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| P40D | 9 | 1234 | CM | 1234012 | 1 | DRUG USED IN NICOTINE DEPENDENCE |
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| N | 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 subjects, who had attempt to reduce nicotine dependence, are included in the FACM dataset.
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Row | STUDYID | DOMAIN | USUBJID | FASEQ | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FASTRESC | FADTC |
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1 | 1234 | FA | 1234005 | 1 | TOTNUM | Total Number | DRUG USED IN NICOTINE DEPENDENCE | 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 | 2008-06-12 |
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