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These example SDTM datasets represent the data collected on the above CRF.

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Current type of smokeless tobacco used, Snuff, Chewing tobacco. Amount Used : Cans/pouches per week, Dips per day Dipping tobacco is a type of finely ground or shredded, moistened smokeless tobacco product. It is commonly and idiomatically known as "dip". Dipping tobacco is used by placing a pinch, or "dip", of tobacco between the lip and the gum (sublabial administration). The act of using it is called dipping.

Other users of tobacco in household

Years of regular smokeless tobacco use

Fagerstrom Test for Nicotine Dependence (FND) The Fagerström Tolerance Questionnaire was developed by Karl-Olov Fagerström. This instrument was modified to the Fagerström Test for Nicotine Dependence by Todd Heatherton, et al. in 1991. The FTND is copyrighted by Taylor and Francis Ltd., but may be reproduced without permission, as available from the source reference (Heatherton, et al., 1991).

Smoking status (self-reported and biochemically validated)

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Rowcaps

Row 1:

Subject 1234005 is a 2-pack/day current smoker. “Current” implies that smoking started sometime before the time the question was asked (SUSTTPT = "2006-01-01", SUSTRTPT = "BEFORE") and had not ended as of that date (SUENTTP = "2006-01-01", SUENRTPT = "ONGOING"). See Section 4.4.7, Use of Relative Timing Variables for the use of these variables. Both the beginning and ending reference time points for this question are the date of the assessment.

Row 2:

Subject 1234005 drank 3 cups of coffee on the day of the assessment.

Row 3:

Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC.

Row 4:

Subject 1234006 drank tea on the day of the assessment.

Row 5:

Subject 1234006 drank coffee on the day of the assessment.

Row 6:

Subject 1234007 had missing data for the smoking questions; this is indicated by SUOCCUR null and SUSTAT = "NOT DONE". The reason is in SUREASND.

Row 7:

Subject 1234007 also had missing data for all of the caffeine questions.

Rows 1, 3, 7, 9:

Show whether the subject has used any medications to help with nicotine dependence. This was prespecified 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. 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 prespecified.

Dataset2

SUPRESPSUOCCURSMOKELESS CIGARETTES

Row	STUDYID	DOMAIN	USUBJID	SUSEQCMSEQ	SUTRTCMTRT	SUCATCMCAT	CMSCAT	CMPRESP	SUSTATCMOCCUR	SUREASNDCMDTC	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTTPT	SUSTRTPT	SUENTPT	SUENRTPT	CMDUR
1	1234	SUCM	1234005	1	CIGARETTES	TOBACCO	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2	PACK	QD	2006-01-01	BEFORE	2006-01-01	ONGOING2008-08-08
2	1234	SUCM	1234005	2	COFFEE	CAFFEINE	Y	Y	3	CUP	QD	2006-01-01	NICOTINE PATCH XYZ	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P2M
2006-01-01	3	1234	SUCM	1234006	1	CIGARETTES	TOBACCODRUG USED IN NICOTINE DEPENDENCE			Y	Y	1	PACK	QD	2003	2006-03-15	BEFORE	2008-11-12
4	1234	SUCM	1234006	2	TEA	CAFFEINE	Y	Y	1	CUP	QD	2006-03-15	2006-03-15	5	1234	SU	1234006	3	COFFEE	CAFFEINE	Y	Y	2	CUP	QD	2006-03-15	2006-03-15	6	1234	SU	1234007	1	CIGARETTES	TOBACCO	Y	NOT DONE	Subject left office before CRF was completed	7	1234	SU	1234007	2	CAFFEINE	CAFFEINE	Y	NOT DONE	Subject left office before CRF was completed	NICOTINE REPLACEMENT THERAPY	NICOTINE	Y OR N	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

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.

Dataset wrap

Name	fasu	facm

Rowcaps

Rows 1, 6, 11:

Rows 2-5, 7-10, 12-15:

Dataset2

Row	STUDYID	DOMAIN	USUBJID	FASEQFASPID	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FASTRESC	FADTC	FATPT	FATPTNUM	FAELTM	FATPTREF
1	ABC1234	FA	ABC-1231234005	1	90567TOTNUM	NUMBER	NRT	TOBACCO CESSATION ATTEMPTS	10	10	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING	2	ABC	FA	ABC-123	2	90567	OCCUR	AGE STARTED SMOKING ( Or Tobacco Product) DAILY	16	16	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING	3	ABC	FA	ABC-123	3	90567	OCCUR	NUMBER	PHARMACUETIAL	N	N	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING	4	ABC	FA	ABC-123	4	90567	OCCUR	Occurrence Indicator	SMO:	Y	Y	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING	5	ABC	FA	ABC-123	5	90567	OCCUR	Occurrence Indicator	Aura	Y	Y	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING	6	ABC	FA	ABC-123	6	90567	SEV	Severity/Intensity	Migraine	MODERATE	MODERATE	2007-05-16	30M POST-DOSE	2	PT30M	DOSING	7	ABC	FA	ABC-123	7	90567	OCCUR	Occurrence Indicator	Sensitivity To Light	Y	Y	2007-05-16	30M POST-DOSE	2	PT30M	DOSING	8	ABC	FA	ABC-123	8	90567	OCCUR	Occurrence Indicator	Sensitivity To Sound	N	N	2007-05-16	30M POST-DOSE	2	PT30M	DOSING	9	ABC	FA	ABC-123	9	90567	OCCUR	Occurrence Indicator	Nausea	N	N	2007-05-16	30M POST-DOSE	2	PT30M	DOSING	10	ABC	FA	ABC-123	10	90567	OCCUR	Occurrence Indicator	Aura	Y	Y	2007-05-16	30M POST-DOSE	2	PT30M	DOSING	11	ABC	FA	ABC-123	11	90567	SEV	Severity/Intensity	Migraine	MILD	MILD	2007-05-16	90M POST-DOSE	3	PT90M	DOSING	12	ABC	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	FA	ABC-123	12	90567	OCCUR	Occurrence Indicator	Sensitivity To Light	N	N	2007-05-16	90M POST-DOSE	3	PT90M	DOSING	13	ABC	FA	ABC-123	13	90567	OCCUR	Occurrence Indicator	Sensitivity To Sound	N	N	2007-05-16	90M POST-DOSE	3	PT90M	DOSING	14	ABC	FA	ABC-123	14	90567	OCCUR	Occurrence Indicator	Nausea	N	N	2007-05-16	90M POST-DOSE	3	PT90M	DOSING	15	ABC	FA	ABC-123	15	90567	OCCUR	Occurrence Indicator	Aura	N	N	2007-05-16	90M POST-DOSE	3	PT90M	DOSING

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