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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 medically acceptable products used to reduce nicotine dependency. These products are represented in the Concomitant Medication (CM) domain. 

Record the information for the last attempt to to reduce nicotine dependency for each type of product used.  

NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS;  OTHER SMOKING CESSATION AIDS

What was the name of the product the subject used to reduce nicotine dependency? 
Panel
title PRODUCTS USED TO REDUCE NICOTINE DEPENDENCY
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 reduce nicotine dependency?Indicate if the subject had used any medically acceptable products to attempt to reduce nicotine dependencyTextCMOCCURCMOCCUR where CMTRT= "DRUG USED IN NICOTINE DEPENDENCE" (NY)Yes; NoFAORRES3How many times did the subject attempt to use a medically acceptable products to reduce nicotine dependencyTimes the Subject Attempted to Reduce Nicotine DependencyRecord the number of times a subject attempted to use a medically acceptable products to reduce nicotine dependencyTextFAORRESFAORRES where FAOBJ ="DRUG USED IN NICOTINE DEPENDENCE" and FATEST= Total Number "
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 product used?CMCATDRUG USED IN  NICOTINE DEPENDENCECMSCAT3What is the type of product the subject used to attempt to reduce nicotine dependency? Substance Use CategoryRecord the type of product the subject used to reduce nicotine dependency.TextCMSCATCMTRT4TextCMTRTCMDUR6What was the duration of the product usage to reduce nicotine dependency?  DurationProvide the duration of the product used. TextCMDURPromptCMCDURU7What was the duration unit of the product used to reduce nicotine dependency?  UnitSelect the appropriate duration unit of the product used. TextCMDURUDAYS; 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 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 NICOTINE DEPENDENCE

YY2008-08-08
21234CM12340052NICOTINE PATCH XYZNICOTINE REPLACEMENT THERAPYLAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION


P2M
31234CM12340061DRUG USED IN NICOTINE DEPENDENCE

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


P3M
51234CM12340063NICOTINE LOZENGES ABCNICOTINE REPLACEMENT THERAPYLAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION


P2W
61234CM12340061BUPROPIONDRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTSLAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION


P1M
71234CM12340072DRUG USED IN NICOTINE DEPENDENCE

YY2008-06-12
81234CM12340073VARENICLINEDRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTSLAST ATTEMPT ATTEMPTED USE WITH THIS PRODUCTMEDICATION


P40D
91234CM12340121DRUG USED IN NICOTINE DEPENDENCE

NYN2008-03-05

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

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