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.
|Rows 1, 2, 4-6, 8-9:|
Show whether the specific heart failure medication class was prescribed on the date of collection (CMDTC).
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.
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.
|1||ABC123||CM||001||1||ACE Inhibitors||HEART FAILURE MAINTENANCE MEDICATION||Y||N||2017-03-01||CONTRAINDICATION|
|2||ABC123||CM||001||2||ARBs||HEART FAILURE MAINTENANCE MEDICATION||Y||Y||2017-03-01||BEFORE|
|3||ABC123||CM||001||3||Losarton||HEART FAILURE MAINTENANCE MEDICATION||50||mg||DAILY||ORAL||2016-08|
|4||ABC123||CM||001||4||ARNIs||HEART FAILURE MAINTENANCE MEDICATION||Y||N||2017-03-01||CONTRAINDICATION|
|5||ABC123||CM||001||5||Beta Blockers||HEART FAILURE MAINTENANCE MEDICATION||Y||N||2017-03-01||CONTRAINDICATION|
|6||ABC123||CM||001||6||Diuretics||HEART FAILURE MAINTENANCE MEDICATION||Y||Y||2017-03-01||BEFORE|
|7||ABC123||CM||001||7||Furosemide||HEART FAILURE MAINTENANCE MEDICATION||PRN||mg||DAILY||ORAL||2016-02-14||AFTER||N|
HIGHER DOSE REQUIRED
|8||ABC123||CM||001||8||Hydralazine||HEART FAILURE MAINTENANCE MEDICATION||Y||N||2017-03-01||TREATMENT NOT INDICATED|
|9||ABC123||CM||001||9||Nitrates||HEART FAILURE MAINTENANCE MEDICATION||Y||N||2017-03-01||TREATMENT NOT INDICATED|
CM NSV Metadata
|CMREASOC||Reason for Occurrence Value||text||Non-standard Record Qualifier||CRF|
|CMRRGYN||Prescribed Recommended Regimen Indicator||text||Non-standard Record Qualifier||CRF|
|CMRRGREA||Reason Rec Regimen Not Prescribed||text||Non-standard Record Qualifier||CRF|