Concomitant Medication (Including products related to nicotine dependency) (CM,FACM)

The Concomitant Medication (CM) domain is based on the Interventions General Observation class. The CM domain is used to represent information relating to concomitant and prior medications used by the subject, such as those given on an as-needed basis or condition-appropriate medications. The same basic data collection variables should be collected for all medications, treatments, and therapies (prior, general concomitant medications, and medications of interest). Reacreational substances are not represented in this domain (see Section 3.3.2.7,  Prior Usage of Recreational Products (Including Tobacco Products). However, medical products recognized to reduce nicotine dependence would be represented in this domain (e.g., Nicotine replacement patches).   

Example

This is an example CRF used to collect general concomitant medications/products in a study. This CRF was designed to allow the applicant to use either CMENRF or CMENRTPT to represent an intervention was ongoing. In order to save space, some of the example permissible values are only shown in the metadata specifications.

This is the metadata specifications for Section 1 and 2 of the CRF.  

CDASH CM Metadata Specifications

Section 1 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	Were any concomitant medications/products taken?	Any Concomitant Medications/Products	Indicate if the subject took any concomitant medications/products. If Yes, include the appropriate details where indicated on the CRF.	Text			Not Submitted	(NY)

Section 2 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
2	What is the category for the concomitant medication/product?	Concomitant Medication/Product Category	Record the medication/product category, if not pre-printed on the CRF.	Text	CMCAT	CMCAT			GENERAL
3	What is the medication/product line number?	CM Line Number	If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.	Text	CMSPID	CMSPID
4	What was the medication/product?	Medication/Product	Record only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.	Text	CMTRT	CMTRT
5	For what indication was the medication/product taken?	Indication	Record the reason the medication/product was taken based on clinical investigator's evaluation. If taken to treat a condition, and a diagnosis was made, the indication should be the diagnosis. If taken to treat a condition, and no diagnosis was made, the indication should be the signs and symptoms. If taken as prophylaxis, report as "Prophylaxis for " and include a description of the condition(s).	Text	CMINDC	CMINDC
6	What was the individual dose of the medication/product?	Dose	Record the dose of medication/treatment per administration (e.g., 200).	Text	CMDOSTXT OR CMDOSE	CMDOSTXT/  CMDOSE
7	What is the unit?	Unit	Record the dose unit of the dose of medication/product taken (e.g., mg).	Text	CMDOSU	CMDOSU	(UNIT)	CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug
8	What was the dose form of the medication/product?	Dose Form	Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the medication/product  taken.	Text	CMDOSFRM	CMDOSFRM	(FRM)	AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET
9	What was the frequency of the medication/product?	Frequency	Record how often the medication/product was taken (e.g., BID, PRN).	Text	CMDOSFRQ	CMDOSFRQ	(FREQ)	BID; PRN; QD; QID; QM; QOD; TID
10	What was the route of administration of the medication/product?	Route	Provide the route of administration for the medication/product.	Text	CMROUTE	CMROUTE	(ROUTE)	INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL
11	What was the start date?	Start Date	Record the date the  medication/treatment was first taken using this format. If the subject has been taking the medication/product for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date.  Medications/Products taken during the study are expected to have a complete start date. Prior  medications/products that are exclusionary should have both a start date and an end date.	Date	CMSTDTC	CMSTDAT
12	Is the medication ongoing?	Ongoing	Record the  medication/product as ongoing if the subject has not stopped taking the  medication/product at the time of data collection and the end date should be left blank.	Text	CMENRF OR  CMENRTPT	CMENRF or CMENRTPT	(NY)	No; Yes
13	What was the end date?	End Date	Record the date the  medication/product was stopped using this format. If the subject has not stopped taking the  medication/product leave this field blank.	Date	CMENDTC	CMENDAT

This is the SDTM dataset associated with the above example CRF. This SDTM dataset used CMENRF to represent ongoing interventions. More information can be found in Section 2.8.7.6, Representing References and Relative Timing. 

The applicant included CMDECOD. The applicant is required to provide the dictionary name and version in the Define-XML document. 

cm.xpt

Rows 1-4:	The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE.
Rows 6-8:	The subject reports the use of 3 medications. Diovan and Zoloft were still being taken by the subject, Astelin was a nasal spray where 2 sprays were taken twice a day in each nostril. Note that only partial start dates are provided for Diovan and Zoloft.
Row 9:	The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating the product in this study.

cm.xpt

cm.xpt

Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMDECOD	CMINDC	CMCLAS	CMDOSE	CMDOSTXT	CMDOSU	CMDOSFRM	CMDOSFRQ	CMROUTE	CMSTDTC	CMENDTC	CMENRF
1	ABC123	CM	ABC123-0001	1	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-14	2006-10-14
2	ABC123	CM	ABC123-0001	2	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-15	2006-10-15
3	ABC123	CM	ABC123-0001	3	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-16	2006-10-16
4	ABC123	CM	ABC123-0001	4	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-17	2006-10-17
5	ABC123	CM	ABC123-0001	5	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-01-18	2006-01-18
6	ABC123	CM	ABC123-0002	1	DIOVAN	valsartan	HYPERTENSION	ANTIHYPERTENSIVES	20		mg	TABLET	BID	ORAL	2004		AFTER
7	ABC123	CM	ABC123-0002	2	ZOLOFT	sertraline	PANIC ATTACKS	PSYCHOANALEPTICS	50		mg	TABLET	OD	ORAL	2004-01		AFTER
8	ABC123	CM	ABC123-0002	3	ASTELIN	azelastine	INFLUENZA	NASAL PREPARATIONS		2 sprays in each nostril-137 mcg	mcg	SPRAY	BID	NASAL	2006-02-26		AFTER
9	ABC123	CM	ABC123-0002	4	ASPIRIN	acetylsalicylic acid	PAIN	ANALGESICS	100		mg	TABLET	PRN	ORAL	2004-01-01		AFTER

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The sponsor only collected details on the last attempt to reduce nicotine dependency for each type of product used. These products are represented in the Concomitant Medication (CM) domain.

CDASH CM Metadata Specifications

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	What was the medically recognized product name?	Medication		Text	CMTRTC	CMTRT				DRUG USED IN  NICOTINE DEPENDENCE
2		Pre-Specified Intervention		Text	CMPRESP	CMPRESP				Y
3	Did the subject previously use medically recognized products to reduce nicotine dependency?	Any Medically Rrecognized Products Taken For Nicotine Dependency	Indicate if the subject had used any medically recognized products to attempt to reduce nicotine dependency	Text	CMOCCUR	CMOCCUR		(NY)	No;Yes;Not Done
4	How many times did the subject attempt to use use medically recognized products to reduce nicotine dependency	Times the Subject Attempted to Reduce Nicotine Dependency	Record the number of times a subject attempted to use medically recognized products to reduce nicotine dependency	Text	FAORRES	FAORRES	FAORRES where FAOBJ ="MEDICATION USED IN NICOTINE DEPENDENCE" and FATEST= Total Number "
5		Category		Text	FACAT	FACAT				ATTEMPTS TO REDUCE NICOTINE DEPENDENCE

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
6	What is the category of the medication/product the subject used to attempt to reduce nicotine dependency?	Medication		Text	CMTRT	CMCAT			NICOTINE REPLACEMENT THERAPY: NOT A NRT
7	What is the medication/product subcategory, if not pre-printed on the CRF.	Subcategory	Applicant Defined	Text	CMSCAT	CMSCAT			LAST ATTEMPTED USE WITH THIS MEDICATION
8	What was the name of the medication/product the subject used to reduce nicotine dependency?	Medication	Record only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.	Text	CMTRT	CMTRT
9	What was the duration of the medication/product used to reduce nicotine dependency for the last attempt?	Collected Duration	Provide the duration of the medication/product used.	Text	CMCDUR	CMDUR
10	What was the duration unit of the medication/product used to reduce nicotine dependency for the last attempt?	Collected Duration Unit	Select the appropriate duration unit of the medication/product used.	Text	CMCDURU	CMDUR		(UNIT)	DAYS; MONTHS; YEARS

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

xx.xpt

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.

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 XYZ	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P2M
3	1234	CM	1234006	1	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2008-11-12
4	1234	CM	1234006	2	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

$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. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.  

facm.xpt

fa.xpt

facm.xpt

Row	STUDYID	DOMAIN	USUBJID	FASEQ	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FASTRESC	FADTC
1	1234	FA	1234005	1	TOTNUM	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

$warningHtml

Example

This example is an additional example of data collected on the previous use of smoking cessation products at the baseline visit.  This example illustrates the use of CMOCCUR and CMPRESP. The reason why a product was discontinued and any use in the last 14 days was of interest.  

 

This example CRF has 2 sections: Questions in the first section focus on whether any smoking cessation product has been used, and the questions in the second section collect each individual product used. In order to save space, some of the permissible values are only shown in the metadata specifications. 

CDASH CM Metadata Specifications

Section 1 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	What is the category for the medication?	Concomitant Medication Category		Text	CMCAT					SMOKING CESSATION PRODUCT
2	Were any smoking cessation products taken?	Any Smoking Cessation Products Taken	Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF.	Text	CMOCCUR	CMOCCUR;		(NY)	No;Yes

Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.  

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
3	What was the smoking cessation product used?	Smoking Cessation Product	Select the smoking cessation product.	Text	CMTRT	CMTRT	CMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.		NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER
4	Did the subject previously use the selected medication/product for smoking cessation?	Smoking Cessation Product Used	Indicate if the subject had used the selected smoking cessation product	Text	CMOCCUR	CMOCCUR		(NY)	No; Yes
5	What was the name of the other smoking cessation product used?	Smoking Cessation Product Other	Indicate the Other type of product previously used.	Text	CMTRTO	CMTRT
6	Was the smoking cessation product discontinued due to an adverse experience?	Reason Smoking Cessation Product Discontinued	Indicate if the product was discontinued due to an Adverse Experience	Text	CMRSDISC	CMRSDISC	If Yes then CMRSDISC = "ADVERSE EXPERIENCE"	(NY)	No:Yes:
7	What was the last date the product was used?	Last Date Smoking Cessation Product Used	Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise, partial dates can be recorded.	Date	CMENDAT	CMENDTC

This is the SDTM date for the data collected above. In this example, the applicant only represented whether the product was used in the last 14 days. CMPRESP was populated by the applicant for all pre-specified products. Medication specified as "OTHER" were not considered prespecified.   

cm.xpt

Row 1:	Shows the subject reported they had not previously used any smoking cessation product ( CMOCCUR ="N") . CMPRESP was included to indicate that the use of smoking cessation product was specifically asked on the CRF.
Rows 2, 5, 8, 11, 14, 17:	Show the subject reported they had used a smoking cessation product (CMOCCUR ="Y") . CMPRESP was included to indicate that the use of a smoking cessation product was specifically asked on the CRF.
Rows 3, 6, 9, 12, 15, 18:	Show the subject reported they had not used nicotine patches (CMOCCUR is "N"). Note: that all other rows for the products not used are not show for simplicity CMPRESP is used to represent that this product was pre-specified.
Rows 4, 7, 10, 13, 16:	Shows the subject reported using the product specified in CMTRT. CMENDTC indicates the last day the product was used. CMPRESP is used to represent that this product was pre-specified. CMOCCUR is Y. Subject ABC-0006 discontinued BUPROPION for an adverse event.
Row 19:	Shows the subject used natural supplement ABC for smoking cessation. Since this product was not specified on the CRF, CMPRESP is null.

Row Captions Debug Message

Remember to keep number agreement between labels and captions.

cm.xpt

cm.xpt

Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMCAT	CMPRESP	CMOCCUR	CMRSDISC	CMDTC	CMENDTC
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		2020-02-15
3	ABC	CM	ABC-0002	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-02-15
4	ABC	CM	ABC-0002	3	NICOTINE GUM	SMOKING CESSATION PRODUCT	Y	Y		2020-02-15	2020-02-02
5	ABC	CM	ABC-0003	1	SMOKING CESSATION PRODUCT		Y	Y		2020-04-15
6	ABC	CM	ABC-0003	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-04-15
7	ABC	CM	ABC-0003	3	NICOTINE LOZENGE	SMOKING CESSATION PRODUCT	Y	Y		2020-04-15	2012
8	ABC	CM	ABC-0004	1	SMOKING CESSATION PRODUCT		Y	Y		2021-04-16
9	ABC	CM	ABC-0004	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-04-16
10	ABC	CM	ABC-0004	3	NICOTINE INHALER	SMOKING CESSATION PRODUCT	Y	Y		2021-04-16	2021-01
11	ABC	CM	ABC-0005	1	SMOKING CESSATION PRODUCT		Y	Y		2020-09-24
12	ABC	CM	ABC-0005	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-09-24
13	ABC	CM	ABC-0005	3	VARENICLINE	SMOKING CESSATION PRODUCT	Y	Y		2020-09-24	2020-08-07
14	ABC	CM	ABC-0006	1	SMOKING CESSATION PRODUCT		Y	Y		2021-04-16
15	ABC	CM	ABC-0002	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2021-04-16
16	ABC	CM	ABC-0006	3	BUPROPION	SMOKING CESSATION PRODUCT	Y	Y	ADVERSE EVENT	2021-04-16	2020-01-09
17	ABC	CM	ABC-0007	1	SMOKING CESSATION PRODUCT		Y	Y		2020-07-10
18	ABC	CM	ABC-0002	2	NICOTINE PAtCH	SMOKING CESSATION PRODUCT	Y	N		2020-07-10
19	ABC	CM	ABC-0007	2	NATURAL SUPPLEMENT ABC	SMOKING CESSATION PRODUCT		Y		2020-07-10	2020-04-10

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.