You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 47 Next »

This is an example of a clinical trial where the sponsor collected information on previous medically recognized products used to reduce nicotine dependency. These products are represented in the Concomitant Medication (CM) domain. These  products are not represented in the SU domaiin. The sponsor assigned CMTRT to the name used in the WHO dictionary for these products.  

PRODUCTS USED TO REDUCE NICOTINE DEPENDENCY
CMCAT
Pre-populated
DRUG USED IN NICOTINE DEPENDENCE
Indicate if the subject had used any medically acceptable products to attempt to reduce nicotine dependencyDid the subject previously use products to reduce nicotine dependency?
CMYN CMOCCUR where CMTRT= "PRODUCT USED IN NICOTINE DEPENDENCE"
<NY codelist>
Record the number of times a subject attempted to use a product to reduce nicotine dependency
FAORRES FAORRES where FAOBJ ="PRODUCT USED IN NICOTINE DEPENDENCE" and FATEST= Total Number "
_________________
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  products to reduce nicotine dependency?
Indicate if the subject had used any medically acceptable products to attempt to reduce nicotine dependencyTextCMOCCURCMOCCUR where CMTRT= "PRODUCT USED IN NICOTINE DEPENDENCE" (NY)Yes; No



FAORRES3How many times did the subject attempt to the product to reduce nicotine dependencyTimes the Subject Attempted to Reduce Nicotine DependencyRecord the number of times a subject attempted to use a product to reduce nicotine dependencyTextFAORRESFAORRES where FAOBJ ="PRODUCT USED IN NICOTINE DEPENDENCE" and FATEST= Total Number "





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

CMCAT
Pre-populated
DRUG USED IN NICOTINE DEPENDENCE
Record the type of product the subject used to reduce nicotine dependency.What is the type of product the subject used to attempt to reduce nicotine dependency?
CMSCAT
CMTRT
_________________
Provide the duration of the product used.
CMDUR
_________________
Select the appropriate duration unit of the product used.Unit
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 product used?


CMCAT


DRUG USED IN  NICOTINE DEPENDENCE


CMSCAT3What 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.TextCMSCAT

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






CMTRT4What was the name of the product the subject used to reduce nicotine dependency? 



TextCMTRT






CMDUR6What was the duration of the product usage to reduce nicotine dependency?  DurationProvide the duration of the product used. TextCMDUR



Prompt

CMCDURU7What was the duration unit of the product used to reduce nicotine dependency?  UnitSelect the appropriate duration unit of the product used. TextCMDURU

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 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 THERAPYLAST ATTEMPT WITH THIS PRODUCT


P2M
31234CM12340061DRUG USED IN NICOTINE DEPENDENCE

YY2008-11-12
41234CM12340062NICOTINE GUMNICOTINE REPLACEMENT THERAPYLAST ATTEMPT WITH THIS PRODUCT


P3M
51234CM12340063NICOTINE LOZENGESNICOTINE REPLACEMENT THERAPYLAST ATTEMPT WITH THIS PRODUCT


P2W
61234CM12340061BUPROPIONDRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTSLAST ATTEMPT WITH THIS PRODUCT


P1M
71234CM12340072DRUG USED IN NICOTINE DEPENDENCE

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


P40D
91234CM12340121DRUG USED IN NICOTINE DEPENDENCE

NN2008-03-05
$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. Ony subjects, who had attempt to reduce nicotine dependence, are included in the FACM dataset.  



fa.xpt

facm.xpt

RowSTUDYIDDOMAINUSUBJIDFASEQFATESTCDFATESTFAOBJFACATFAORRESFASTRESCFADTC
11234FA12340051TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS 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 DEPENDENCE332008-06-12
$warningHtml
  • No labels