Smoking History (Including using Medically Acceptable Smoking Cessation Product Usage Example 2

Drugs used in nicotine dependency are considered medically acceptable drugs and were represented in the Concomitant Medication (CM) domain.

Modelling of this information needs discussion at ISMT.

SMOKING CESSATION PRODUCT

	What is the category of the substance used? CMCAT Pre-populated	DRUG USED IN NICOTINE DEPENDENCE
Indicate if the subject had used any medically acceptable products to attempted to quit smoking	Did the subject previously use any medically acceptable products to attempted to quit smoking? CMYN CMOCCUR where CMTRT= "Drug used in nicotine dependence"	Yes No <NY codelist>
Record the number of times a subject attempt to quit smoking.	How many times did the subject attempt to quit smoking using a smocking cessation product? FAORRES FAORRES where FAOBJ ="Drug used in nicotine dependence" and FATEST= NUMBER OF ATTEMPTS TP QUIT"	_________________

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

CMCAT

1

What is the category of the substance used?

Text

CMCAT

DRUG USED IN NICOTINE DEPENDENCE

CMYN

2

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

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

Text

CMOCCUR

CMOCCUR where CMTRT= "Drug used in nicotine dependence"

(NY)

Yes; No

FAORRES

3

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

Times the subject attempted to quit smoking

Record the number of times a subject attempt to quit smoking.

Text

FAORRES

FAORRES where FAOBJ ="Drug used in nicotine dependence" and FATEST= NUMBER OF ATTEMPTS TP QUIT"

RECORD THE INFORMATION FOR THE LAST ATTEMPT TO QUIT FOR EACH TYPE OF PRODUCT USED COMBINATION OF METHODS SHOULD BE LISTED ON TEH SAME LINE ?????? This is a problem..

	What is the category of the substance used? CMCAT Pre-populated	DRUG USED IN NICOTINE DEPENDENCE
Record the type of product the subject used to attempted to quit smoking.	What is the type of product the subject used to attempted to quit smoking? CMSCAT	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? CMTRT	_________________
Indicate the amount of amount of tobacco product used to quit smoking?	Amount CMDSTXT CMDOSE CMDOSTXT	_________________
Provide the duration of the substance use	Duration CMDUR CMDOSFRQ	_________________
Select the appropriate duration unit of the tobacco product used	Unit CMCDURU CMDUR	DAYS MONTHS YEARS
	Frequency CMDOSFRQ	QD EVERY WEEK QM PA <FREQ codelist>

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

CMCAT

1

What is the category of the substance used?

CMCAT

DRUG USED IN NICOTINE DEPENDENCE

CMSCAT

3

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

Substance Use Category

Record the type of product the subject used to attempted to quit smoking.

Text

CMSCAT

Nicotine Replacement
Therapy (NRT);

Pharmaceuticals
other than NRTs;

Other
Smoking Cessation aids

CMTRT

4

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

Text

CMTRT

CMDSTXT

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

CMDOSE; CMDOSTXT

Prompt

CMDUR

6

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

Duration

Provide the duration of the substance use

Text

CMDOSFRQ

Prompt

CMCDURU

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

CMDUR

DAYS; MONTHS; YEARS

Prompt

CMDOSFRQ

8

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

Frequency

Text

CMDOSFRQ

(FREQ)

QD; EVERY WEEK; QM; PA

Prompt

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

Row Captions Debug Message

Please provide a caption for every row caption label.

cm.xpt

xx.xpt

Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMCAT	CMSCAT	CMPRESP	CMOCCUR	CMDOSE	CMDOSU	CMDOSFRQ	CMSTDTC	CMENDTC	CMSTTPT	CMSTRTPT	CMENTPT	CMENRTPT
1	1234	CM	1234005	1	DRUG USED IN NICOTINE DEPENDENCE			Y	Y						2006-01-01	BEFORE	2006-01-01	ONGOING
2	1234	CM	1234005	2	Nicotine patch	DRUG USED IN NICOTINE DEPENDENCE	NICOTINE REPLACEMENT THERAPY	Y	Y	3	CUP	QD	2006-01-01	2006-01-01
3	1234	CM	1234006	1	Nicotine gum	DRUG USED IN NICOTINE DEPENDENCE	NICOTINE REPLACEMENT THERAPY	Y	Y	1	PACK	QD		2003	2006-03-15	BEFORE
4	1234	CM	1234006	2	Nicotine lozenges:	DRUG USED IN NICOTINE DEPENDENCE	NICOTINE REPLACEMENT THERAPY	Y	Y	1	CUP	QD	2006-03-15	2006-03-15
5	1234	CM	1234006	3	bupropion	DRUG USED IN NICOTINE DEPENDENCE	Pharmaceuticals other than NRTs	Y	Y	2	CUP	QD	2006-03-15	2006-03-15
6	1234	CM	1234007	1	Chantix	DRUG USED IN NICOTINE DEPENDENCE	Pharmaceuticals other than NRTs	Y

Dataset Debug Messages

There are 20 leading, trailing, or non-breaking spaces in the dataset.
Please remove all paragraph and/or line breaks.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Rows 1, 6, 11:
Rows 2-5, 7-10, 12-15:

Row Captions Debug Message

Please provide a caption for every row caption label.

fa.xpt

fasu.xpt

Row	STUDYID	DOMAIN	USUBJID	FASEQ	FASPID	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FASTRESC	FADTC	FATPT	FATPTNUM	FAELTM	FATPTREF
1	ABC	FA	ABC-123	1	90567		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
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

Dataset Debug Message

There are two leading, trailing, or non-breaking spaces in the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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Smoking History (Including using Medically Acceptable Smoking Cessation Product Usage Example 2