An example of the SDTM datasets used to represent the data collected on the above CRF are provided below.
Rows 1, 3, 7, 9:
Show whether the subject has used any medications to help with nicotine dependence. This was pre-specified 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 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
1
1234
CM
1234005
1
DRUG USED IN NICOTINE DEPENDENCE
Y
Y
2008-08-08
2
1234
CM
1234005
2
NICOTINE PATCH XYZ
NICOTINE REPLACEMENT THERAPY
LAST ATTEMPTED USE WITH THIS MEDICATION
P2M
3
1234
CM
1234006
1
DRUG USED IN NICOTINE DEPENDENCE
Y
Y
2008-11-12
4
1234
CM
1234006
2
NICOTINE GUM ABC
NICOTINE REPLACEMENT THERAPY
LAST ATTEMPTED USE WITH THIS MEDICATION
P3M
5
1234
CM
1234006
3
NICOTINE LOZENGES ABC
NICOTINE REPLACEMENT THERAPY
LAST ATTEMPTED USE WITH THIS MEDICATION
P2W
6
1234
CM
1234006
1
BUPROPION
DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS
LAST ATTEMPTED USE WITH THIS MEDICATION
P1M
7
1234
CM
1234007
2
DRUG USED IN NICOTINE DEPENDENCE
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
P40D
9
1234
CM
1234012
1
DRUG USED IN NICOTINE DEPENDENCE
Y
N
2008-03-05
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
FACM was used to represent the total number of times the subject attempted to reduce nicotine dependency using a medically acceptable product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.