This is an example of an SDTM dataset used to represent the data collected on the above CRF.
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.
cm.xpt
xx.xpt
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
NICOTINE REPLACEMENT THERAPY
LAST ATTEMPT WITH THIS PRODUCT
P2M
3
1234
CM
1234006
1
DRUG USED IN NICOTINE DEPENDENCE
Y
Y
2008-11-12
4
1234
CM
1234006
2
NICOTINE GUM
NICOTINE REPLACEMENT THERAPY
LAST ATTEMPT WITH THIS PRODUCT
P3M
5
1234
CM
1234006
3
NICOTINE LOZENGES
NICOTINE REPLACEMENT THERAPY
LAST ATTEMPT WITH THIS PRODUCT
P2W
6
1234
CM
1234006
1
BUPROPION
DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS
LAST ATTEMPT WITH THIS PRODUCT
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 ATTEMPT WITH THIS PRODUCT
P40D
9
1234
CM
1234012
1
DRUG USED IN NICOTINE DEPENDENCE
N
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. Ony subjects, who had attempt to reduce nicotine dependence, are included in the FACM dataset.