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

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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.

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Modelling of this information needs discussion at ISMT.

Should this be related to SU using FASU,

Should the NRT be recorded in CM, or SU.

How to represent in SUCAT Should SUCAT always be TOBACCO... can Nicotine be used.

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Types of tobacco use Cigarette,Cigars,Smokeless Tobacco,Pipe Tobacco,Nicotine Vaping Collected with Check all that appy in CDASH.

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)

RECORD THE INFORMATION FOR THE LAST ATTEMPT TO QUIT FOR EACH TYPE OF PRODUCT USED

Nicotine Replacement
Therapy (NRT

Pharmaceuticals
other than NRTs

Other
Smoking Cessation aids

What was the name of the product the subject used to attempted to quit smoking?

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title	SMOKING CESSATION PRODUCT

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CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

List Style

Hidden

SUCAT

1

What is the category of the substance used?

SMOKING CESSATION PRODUCT

SUYN

2

Did the subject previously use any products to attempted to quit smoking?

Indicate if the subject had used any products to attempted to quit smoking.

SUOCCUR where SUTRT=Smoking Cessation Product"

(NY)

Yes; No

FAORRES

3

How many times did the subject attempt to quit smoking using a smocking cessation product?

FAORRES where FAOBJ ="SMOKING CESSATION PRODUCT" and FATEST= NUMBER OF ATTEMPTS"

Panel

title	SMOKING CESSATION PRODUCT

Xformpusher

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

List Style

Hidden

SUCAT

1

What is the category of the substance used?

SMOKING CESSATION PRODUCT

SUSCAT

3

What is the type of product the subject used to attempted to quit smoking?

Substance Use Category

Record the type of tobacco product used

Text

SUSCAT

SUTRT

4

Text

SUTRT

SUDSTXT

5

What was the amount of product used to quit smoking?

Amount

Indicate the amount of amount of tobacco product used to quit smoking?

Text

SUDOSE; SUDOSTXT

Prompt

SUDUR

6

What was the duration of the product usage to quit smoking?

Duration

Provide the duration of the substance use

Text

SUDOSFRQ

QD; EVERY WEEK; QM; PA

Prompt

SUCDURU

7

What was the duration unit of the product used to quit smoking?

Unit

Select the appropriate duration unit of the tobacco product used

Text

SUDUR

DAYS; MONTHS; YEARS

Prompt

SUDOSFRQ

8

What was the frequency of of the product used to quit smoking

Frequency

(FREQ)

QD; EVERY WEEK; QM; PA

Prompt

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Row 1:
Row 2:	Row 3:	Row 4:	Row 5:	Row 6:	Row 7:

Dataset2

SUSCATSUPRESPSUOCCUR REPLACEMENT THERAPY NICOTINE REPLACEMENT THERAPY

Row	STUDYID	DOMAIN	USUBJID	SUSEQCMSEQ	SUTRTCMTRT	SUCATCMCAT	CMSCAT	CMPRESP	CMOCCUR	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTTPT	SUSTRTPT	SUENTPT	SUENRTPT	CMDTC	CMDUR
1	1234	SUCM	1234005	1	SMOKING CESSATION PRODUCT	SMOKING CESSATION PRODUCT	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	Nicotine patch	SMOKING CESSATION PRODUCT NICOTINE PATCH XYZ	NICOTINE	REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P2M
3	1234	CM	Y	Y	3	CUP	QD	2006-01-01	2006-01-01	3	1234	SU	1234006	1	Nicotine gum	SMOKING CESSATION PRODUCT	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	1	PACK	QD	2003	2006-03-15	BEFORE	2008-11-12
4	1234	SUCM	1234006	2	Nicotine lozenges:	SMOKING CESSATION PRODUCT	NICOTINE REPLACEMENT THERAPY	Y	Y	1	CUP	QD	2006-03-15	2006-03-15	5	1234	SU	1234006	3	bupropion	SMOKING CESSATION PRODUCT	Pharmaceuticals other than NRTs	Y	Y	2	CUP	QD	2006-03-15	2006-03-15	6	1234	SU	1234007	1	Chantix	SMOKING CESSATION PRODUCT	Pharmaceuticals other than NRTsY	Y	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.

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

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Name	facm

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Name	fasu

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Rows 1, 6, 11:

Dataset2

Row	STUDYID	DOMAIN	USUBJID	FASEQ	FASPID	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	TOBACCO CESSATION ATTEMPTS	N	N	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING
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	4	ABC	FA	ABC-123	4	90567	OCCUR	Occurrence Indicator	Y	Y	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING	5	ABC	FA	ABC-123	5	90567	OCCUR	Occurrence Indicator	Y	Y	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING

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Old Version 17

New Version Current

Key

Chantix