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

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. 

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? 
Panel
title SMOKING CESSATION PRODUCT
Xformpusher
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?TextCMCATDRUG  USED IN  NICOTINE DEPENDENCECMYN2Did 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; NoFAORRES3How 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"
Xformpusher
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?CMCATDRUG USED IN  NICOTINE DEPENDENCECMSCAT3What 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. TextCMSCATCMTRT4TextCMTRTCMDUR6What was the duration of the product usage to quit smoking?  DurationProvide the duration of the substance use TextCMDURPromptCMCDURU7What was the duration unit of the product used to quit smoking?  UnitSelect the appropriate duration unit of the  tobacco product usedTextCMDURUDAYS; MONTHS; YEARSPrompt
Dataset wrap
Rowcaps
Rows 1, 3, 7, 9: Show Row 1:Shows whether the subject has used any products medications 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.   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 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.   CMPRESP is null since the specific medication used is not prespecified.   
Dataset2
RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMSCATCMPRESPCMOCCURCMDTCCMDUR
11234CM12340051DRUG USED IN  IN NICOTINE DEPENDENCE DEPENDENCE

YY2008-08-08
21234CM12340052Nicotine patchNICOTINE PATCH XYZNICOTINE REPLACEMENT  THERAPY  REPLACEMENT THERAPYLAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION


P2M
31234CM12340061Nicotine gumNICOTINE REPLACEMENT  THERAPY DRUG USED IN NICOTINE DEPENDENCE

YY2008-11-12
41234CM12340062NICOTINE GUM ABCNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P3M
5LAST ATTEMPT WITH THIS PRODUCTP3M41234CM123400623NICOTINE LOZENGES ABCNicotine lozenges:NICOTINE REPLACEMENT  THERAPY REPLACEMENT THERAPYLAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION


P2W
561234CM123400631BupropionBUPROPIONDRUG USED IN REDUCING NICOTINE DEPENDENCE SMOKING CESSATION PHARMCEUTICALS  OTHER THAN NRTSLAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION


P1M
71234CM12340072DRUG USED IN NICOTINE DEPENDENCE

YY2008-06-12
861234CM123400713VareniclineVARENICLINEDRUG USED IN REDUCING NICOTINE DEPENDENCE SMOKING CESSATION PHARMCEUTICALS  OTHER THAN NRTSLAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION


P40D
91234CM12340121DRUG USED IN NICOTINE DEPENDENCE

YN2008-03-05

FACM was used to represent the total number of times the subject attempt to quit smoking attempted to reduce nicotine dependency using a medically acceptable smoking cessation product.product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.  

Dataset wrap
Namefacm
Dataset2
RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFASTRESCFADTC
1ABC1234FAABC-12312340051TOTNUMNUMBER Total NumberDRUG USED IN NICOTINE DEPENDENCE DEPENDENCETOBACCO CESSATION ATTEMPTS TO REDUCE NICOTINE DEPENDENCE442008-08-08
21234FA12340061TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE552008-11-12
31234FA12340071TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE332008-06-122007-05-16