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This is an example of a clinical trial where the sponsor collected information on previous products used to reduce nicotine dependency. These products are considered medically acceptable drugs and were represented in the Concomitant Medication (CM) domain. 


SMOKING CESSATION PRODUCT
CMCAT
Pre-populated
DRUG USED IN NICOTINE DEPENDENCE
Indicate if the subject had used any medically acceptable products to attempted to quit smokingDid the subject previously use any medically acceptable products to attempted to quit smoking?
CMYN CMOCCUR where CMTRT= "Drug used in nicotine dependence"
<NY codelist>
Record the number of times a subject attempt to quit smoking.
FAORRES FAORRES where FAOBJ ="Drug used in nicotine dependence" and FATEST= NUMBER OF ATTEMPTS TP QUIT"
_________________
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
CMCAT1What is the category of the substance used?

TextCMCAT


DRUG  USED IN  NICOTINE DEPENDENCE


CMYN2Did 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 smokingTextCMOCCURCMOCCUR where CMTRT= "Drug used in nicotine dependence" (NY)Yes; No



FAORRES3How 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. TextFAORRESFAORRES 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. 

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
CMTRT
_________________
Provide the duration of the substance use
CMDUR
_________________
Select the appropriate duration unit of the tobacco product usedUnit
CMCDURU CMDURU
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
CMCAT1What is the category of the substance used?


CMCAT


DRUG USED IN  NICOTINE DEPENDENCE


CMSCAT3What is the type of product the subject used to attempted to quit smoking? Substance Use CategoryRecord the type of product the subject used to attempted to quit smoking. TextCMSCAT

Nicotine Replacement
Therapy (NRT);

Pharmaceuticals
other than NRTs; 

Other
Smoking Cessation aids







CMTRT4What was the  name of the product the subject used to attempted to quit smoking? 



TextCMTRT






CMDUR6What was the duration of the product usage to quit smoking?  DurationProvide the duration of the substance use TextCMDUR



Prompt

CMCDURU7What was the duration unit of the product used to quit smoking?  UnitSelect the appropriate duration unit of the  tobacco product usedTextCMDURU

DAYS; MONTHS; YEARS
Prompt

Row 1:Shows whether the subject has used any products to help with nicotine dependence. These include nicotine replacement therapies and pharmaceuticals drugs like Varenicline. The sponsor assigned CMTRT to the name used in the WHO dictionary for these products. CMDTC is the date this assessment was made.
Rows 2-6:Show the various smoking cessation products products that were used by subjects. 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.

cm.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMSCATCMPRESPCMOCCURCMDTCCMDUR
11234CM12340051DRUG USED IN  NICOTINE DEPENDENCE 

YY2008-08-08
21234CM12340052Nicotine patchNICOTINE REPLACEMENT  THERAPY  LAST ATTEMPT WITH THIS PRODUCT


P2M
31234CM12340061Nicotine gumNICOTINE REPLACEMENT  THERAPY LAST ATTEMPT WITH THIS PRODUCT


P3M
41234CM12340062Nicotine lozenges:NICOTINE REPLACEMENT  THERAPY LAST ATTEMPT WITH THIS PRODUCT


P2W
51234CM12340063BupropionSMOKING CESSATION PHARMCEUTICALS  OTHER THAN NRTSLAST ATTEMPT WITH THIS PRODUCT


P1M
61234CM12340071VareniclineSMOKING CESSATION PHARMCEUTICALS  OTHER THAN NRTSLAST ATTEMPT WITH THIS PRODUCT


P40D

Dataset Debug Messages

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Dataset Wrapper Debug Message

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FACM was used to represent the total number of times the subject attempt to quit smoking using a medically acceptable smoking cessation product.



fa.xpt

facm.xpt

RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFASTRESCFADTC
1ABCFAABC-1231
NUMBER DRUG USED IN NICOTINE DEPENDENCE TOBACCO CESSATION ATTEMPTS442007-05-16

Dataset Debug Message

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

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