Heart Failure Background Maintenance Medications

Illustrates Domains

CM

Illustrates Variables

CMSTRF
CMENRF
CMREASOC
CMRRGYN
CMRRGREA


Content

Data on background treatment is represented in the Concomitant/Prior Medications (CM) domain. 

  • NSCM.CMREASOC was used to represent the reason why the medication class was not taken. In this study, the sponsor included the reason CONTRAINDICATION, but did not collect the specific contraindication.       
  • Because CMTRT is a required variable, the sponsor populated the variable with the specific name or class of the medication, coded using a standard dictionary. Although the coding variables are not shown here, CMCLAS and CMCLASCD may be used to indicate the drug class. CMDECOD would contain the standardized or dictionary-derived text description for CMTRT. If CMTRT does not have a decode value in the dictionary, then CMDECOD will be left blank. In this case, the sponsor did not ask the investigator to specify the medication class for each medication taken.
  • CMDTC was only included by the sponsor for general questions about the use of each class of medication at baseline. The collection date provides a time-frame reference for the observation. This time-frame reference is not relevant for the observation for each specific medication used, as the actual start and end dates are collected.
cm.xpt
Rows 1, 2, 4-6, 8-9:

Show whether the specific heart failure medication class was prescribed on the date of collection (CMDTC).

Row 3:

Shows the specific heart failure medication taken. CMENRF was used to indicate that the medication was ongoing at the end of the study reference period. For this subject, the dose was not changed during the study.

Row 7:

Shows the specific heart failure medication taken. The sponsor did not collect the specific doses of furosemide used, as subjects were permitted to change the dose as needed.

cm.xpt

RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMPRESPCMOCCURCMDOSECMDOSUCMDOSFRQCMROUTECMDTCCMSTDTCCMENDTCCMSTRFCMENRF
CMREASOCCMRRGYNCMRRGREA
1ABC123CM0011ACE InhibitorsHEART FAILURE MAINTENANCE MEDICATIONYN



2017-03-01




CONTRAINDICATION

2ABC123CM0012ARBsHEART FAILURE MAINTENANCE MEDICATIONYY



2017-03-01

BEFORE




3ABC123CM0013LosartonHEART FAILURE MAINTENANCE MEDICATION

50mgDAILYORAL
2016-08


AFTER



Y
4ABC123CM0014ARNIsHEART FAILURE MAINTENANCE MEDICATIONYN



2017-03-01




CONTRAINDICATION

5ABC123CM0015Beta BlockersHEART FAILURE MAINTENANCE MEDICATIONYN



2017-03-01




CONTRAINDICATION

6ABC123CM0016DiureticsHEART FAILURE MAINTENANCE MEDICATIONYY



2017-03-01

BEFORE




7ABC123CM0017FurosemideHEART FAILURE MAINTENANCE MEDICATION

PRNmgDAILYORAL
2016-02-14

AFTER

N

HIGHER DOSE REQUIRED

8ABC123CM0018HydralazineHEART FAILURE MAINTENANCE MEDICATIONYN



2017-03-01




TREATMENT NOT INDICATED

9ABC123CM0019NitratesHEART FAILURE MAINTENANCE MEDICATIONYN



2017-03-01




TREATMENT NOT INDICATED

CM NSV Metadata