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The Concomitant Medication (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. However, medical proudcts recognized to reduce nicotine dependence would be represented in this domain (e.g., Nicotine replacement patches).   

Example

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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. 

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.

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RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMDECODCMINDCCMCLASCMDOSECMDOSTXTCMDOSUCMDOSFRMCMDOSFRQCMROUTECMSTDTCCMENDTCCMENRF
1ABC123CMABC123-00011ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-142006-10-14
2ABC123CMABC123-00012ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-152006-10-15
3ABC123CMABC123-00013ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-162006-10-16
4ABC123CMABC123-00014ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-172006-10-17
5ABC123CMABC123-00015ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-01-182006-01-18
6ABC123CMABC123-00021DIOVANvalsartanHYPERTENSIONANTIHYPERTENSIVES20
mgTABLETBIDORAL2004
AFTER
7ABC123CMABC123-00022ZOLOFTsertralinePANIC ATTACKSPSYCHOANALEPTICS50
mgTABLETODORAL2004-01
AFTER
8ABC123CMABC123-00023ASTELINazelastineINFLUENZANASAL PREPARATIONS
2 sprays in each nostril-137 mcgmcgSPRAYBIDNASAL2006-02-26
AFTER
9ABC123CMABC123-00024ASPIRINacetylsalicylic acidPAINANALGESICS100
mgTABLETPRNORAL2004-01-01
AFTER
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

Below is an example ADaM dataset designed to support the summarization of concomitant medications. Included are a subset of variables that are commonly included to support a basic summary table.

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Row

STUDYID

USUBJIDCMTRTCMDECODCMCLASASTDTASTDTFAENDTAENDTFASTDYAENDYAOCCFLAOCCPFLAOCC01FLPREFLONTRTFLFUPFLTRTPSAFFLCMDOSECMDOSTXTCMDOSUCMINDCCMDOSFRMCMDOSFRQCMROUTECMSTDTCCMENDTCCMENRFCMSEQ
1ABC123A2001ASPIRINacetylsalicylic acidANALGESICS21JAN2021
22JAN2021
12YYY

Y


PlaceboY100
mgMIGRAINETABLETONCEORAL2021-01-212021-01-22
1
2ABC123A2008DIOVANvalsartanANTIHYPERTENSIVES01JAN2004M

-6230




YYProduct AY20
mgHYPERTENSIONTABLETBIDORAL2004
AFTER2
3ABC123A2008ZOLOFTsertralinePSYCHOANALEPTICS01JAN2010D

-4038




YYProduct AY50
mgPANIC ATTACKSTABLETQDORAL2010-01
AFTER3
4ABC123A2008ASTELINazelastineNASAL PREPARATIONS26FEB2006


-5443




YYProduct AY
2 sprays in each nostril-137 mcgmcgINFLUENZASPRAYBIDNASAL2006-02-26
AFTER4
5ABC123A3009ASPIRINacetylsalicylic acidANALGESICS01JAN2004


-6230




YYProduct BY100
mgPAINTABLETPRNORAL2004-01-01
AFTER5
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ADCM Dataset Metadata

ADCM Variable Metadata

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