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

Compare with Current View Page History

« Previous Version 13 Next »

The Concomitant Medication (CM) domain is based on the Interventions General Observation class. The 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

This is an example CRF used to collect general concomitant medications/products in a study. This CRF was designed to allow the applicant to use either CMENRF or CMENRTPT to represent an intervention was ongoing. In order to save space, some of the example permissible values are only shown in the metadata specifications.


This is the metadata specifications for Section 1 and 2 of the CRF.  

Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Were any concomitant medications/products taken?Any Concomitant Medications/ProductsIndicate if the subject took any concomitant medications/products. If Yes, include the appropriate details where indicated on the CRF.Text

Not Submitted(NY)

Section 2 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What is the category for the concomitant medication/product?Concomitant Medication/Product CategoryRecord the medication/product category, if not pre-printed on the CRF.TextCMCATCMCAT

GENERAL
3What is the medication/product line number?CM Line NumberIf collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.TextCMSPIDCMSPID



4What was the medication/product?Medication/ProductRecord only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.TextCMTRTCMTRT



5For what indication was the medication/product taken?IndicationRecord the reason the medication/product was taken based on clinical investigator's evaluation. If taken to treat a condition, and a diagnosis was made, the indication should be the diagnosis. If taken to treat a condition, and no diagnosis was made, the indication should be the signs and symptoms. If taken as prophylaxis, report as "Prophylaxis for " and include a description of the condition(s).TextCMINDCCMINDC



6What was the individual dose of the medication/product?DoseRecord the dose of medication/treatment per administration (e.g., 200).TextCMDOSTXT OR CMDOSECMDOSTXT/  CMDOSE



7What is the unit?UnitRecord the dose unit of the dose of medication/product taken (e.g., mg).TextCMDOSUCMDOSU(UNIT)CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug

8What was the dose form of the medication/product?Dose FormRecord the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the medication/product  taken.TextCMDOSFRMCMDOSFRM(FRM)AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET

9What was the frequency of the medication/product?FrequencyRecord how often the medication/product was taken (e.g., BID, PRN).TextCMDOSFRQCMDOSFRQ(FREQ)BID; PRN; QD; QID; QM; QOD; TID

10What was the route of administration of the medication/product?RouteProvide the route of administration for the medication/product.TextCMROUTECMROUTE(ROUTE)INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL

11What was the start date?Start DateRecord the date the  medication/treatment was first taken using this format. If the subject has been taking the medication/product for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date.  Medications/Products taken during the study are expected to have a complete start date. Prior  medications/products that are exclusionary should have both a start date and an end date.DateCMSTDTCCMSTDAT



12Is the medication ongoing?OngoingRecord the  medication/product as ongoing if the subject has not stopped taking the  medication/product at the time of data collection and the end date should be left blank.TextCMENRF OR  CMENRTPTCMENRF or CMENRTPT(NY)No; Yes

13What was the end date?End DateRecord the date the  medication/product was stopped using this format. If the subject has not stopped taking the  medication/product leave this field blank.DateCMENDTCCMENDAT





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.

cm.xpt

cm.xpt

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
$warningHtml

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.

$titleHtml

adcm.xpt

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
$warningHtml

ADCM Dataset Metadata

ADCM Variable Metadata

  • No labels