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Order	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	SDTMIG Target Mapping	Controlled Terminology Code List Name	Permissible Values	Pre-Populated Value	Hidden
1	CMCAT	What is the category for the medication?	Concomitant Medication Category		Text	CMCAT				SMOKING CESSATION PRODUCT	Yes
2	CMTRT	What was the smoking cessation product?	Smoking Cessation Product	Indicate the type of smoking cessation products previously used. For each product type previously used complete a new line.	Text	CMTRT			NICOTINE PATCHESPATCHE; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER
3	CMTRTOT	What was the name of the other smoking cessation product used?	Smoking Cessation Product Other	Indicate the Other type of smoking cessation product previously used.	Text	CMTRT
4	CMCRSDIS	Was the smoking cessation product discontinued due to a adverse event ?	Reason Smoking Cessation Product Discontinued	Indicate if the smoking cessation product was discontinued due to a Adverse Event	Text	CMRSDISC	If Yes then CMRSDISC = "ADVERSE EVENT"	(NY)	Yes; No
5	CMENDTC	Was the product used in the last 14 days?				CMENDTC			Yes; No

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Dataset wrap

Name	cm

Rowcaps

Row 1:	Shows the subject reported they had not previously used any smoking cessation product (e.g., CMOCCUR =N) . CMPRESP was include to indicate that the use of smoking cessation product was specifically asked.
Rows 2,4,6,8,10,12	Show the subjects reported they had previously used smoking cessation products.
Row 2:	Shows the subject reported using Nicotine Gum. This gum was used within 14 days of the date of collection. Since the last date of use is not known, CMENDTC describe the beginning and the end of the interval of uncertainty. The dates are separated with a solidus, as shown in the table. CMPRESP is used to repesent that this product was pre-specified.. CMOCCUR is null, since the sponsor did not directly ask on the CRF whether the product was taken. The investigator just checked which products were used.
Row 5:	Shows the subject reported the previous use of a nicotine lozenge at Visit 1, which occurred on 2020-02-15. This usage was ended at least 14 days prior to the date of collection. CMENTPT represented the date 14 days prior to the visit 1 date, in this case 2020-04-01. CMENRTPT indicates the usage ended prior to the date in CMENTPT.
Rows 7,9,11	Show the subjects used the product shown in CMTRT. Subject ABC-0006 discontinued Zyban BUPROPION for an adverse event.
Row 13	Shows the subject used Bupropion for smoking cessation. Since, this product was not specifed on the CRF, CMPRESP is null.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMCAT	CMPRESP	CMOCCUR	CMRSDISC	CMDTC	CMENDTC	CMENRTPT	CMENTPT
1	ABC	CM	ABC-0001	1	SMOKING CESSATION PRODUCT		Y	N		2020-01-05
2	ABC	CM	ABC-0002	1	SMOKING CESSATION PRODUCT		Y	Y		2020-01-05
3	ABC	CM	ABC-0002	2	NICOTINE GUM	SMOKING CESSATION PRODUCT	Y			2020-02-15	2020-02-02/2003-02-15
4	ABC	CM	ABC-0003	1	SMOKING CESSATION PRODUCT		Y	Y		2020-04-15
5	ABC	CM	ABC-0003	2	NICOTINE LOZENGE	SMOKING CESSATION PRODUCT	Y			2020-04-15		PRIOR	2020-04-02
6	ABC	CM	ABC-0004	1	SMOKING CESSATION PRODUCT		Y	Y		2021-04-16
7	ABC	CM	ABC-0004	2	NICOTINE INHALER	SMOKING CESSATION PRODUCT	Y			2021-04-16	2021-01-07
8	ABC	CM	ABC-0005	1	SMOKING CESSATION PRODUCT		Y	Y		2020-09-24
9	ABC	CM	ABC-0005	2	CHANTIXVARENICLINE	SMOKING CESSATION PRODUCT	Y			2020-09-24	2020-08-07
10	ABC	CM	ABC-0006	1	SMOKING CESSATION PRODUCT		Y	Y		2021-04-16
11	ABC	CM	ABC-0006	2	ZYBANBUPROPION	SMOKING CESSATION PRODUCT	Y		ADVERSE EVENT	2021-04-16	2020-01-09
12	ABC	CM	ABC-0007	1	SMOKING CESSATION PRODUCT		Y	Y		2020-07-10
13	ABC	CM	ABC-0007	2	BUPROPION	SMOKING CESSATION PRODUCT				2020-07-10	2020-04-10

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