Heart Failure Medical History

Illustrates Domains

MH
CV
HO
CM

Illustrates Variables

MHLLT
MHDECOD
MHEVDTYP
MHEVLINT
CVORRES
CVSTRESC
CVSTRESN
CVSTRESU
HOEVLINT
HOINDC
HOCRNORD
CMINDC
CMROUTE


Content

This example shows the representation of medical history data related to the subject's heart failure diagnosis and the most recent episode of worsening heart failure. The sponsor populated MHTERM with terms used in the protocol. Medical history events were coded using the Medical Dictionary for Regulatory Activities (MedDRA); however, only some of the coding variables are shown (MHLLT and MHDECOD). Sponsors may decide to use other MedDRA terms based on definitions provided in the protocol. MHMODIFY may also be used if MHTERM was modified to facilitate coding.

mh.xpt
Row 1:

Shows the date of diagnosis of heart failure. The specific type of heart failure was collected on the CRF and used to populate MHTERM. NSVs were used for primary cause and etiology.

Row 2:

Shows the date of the most recent episode of worsening heart failure in the last 6 months (MHEVLINT = -P6M).

mh.xpt

RowSTUDYIDDOMAINUSUBJIDMHSEQMHTERMMHLLTMHDECODMHEVDTYPMHCATMHPRESPMHOCCURMHSTDTCMHEVLINT
MHPRCMHETOLGYMHCRNORD
1AAA123MH0011HEART FAILURE WITH REDUCED EJECTION FRACTIONHeart failure with reduced ejection fractionCardiac failureDIAGNOSISHEART FAILURE HISTORYYY2018-04-21

CORONARY ARTERY DISEASEISCHEMIC
2AAA123MH0012WORSENING HEART FAILURECardiac failure aggravatedCardiac failureEPISODEHEART FAILURE HISTORYYY2018-05-15-P6M


MOST RECENT

MH NSV Metadata

Left ventricular ejection fraction (LVEF) is a physiologic finding about the heart, and is therefore represented in the CV domain. In this case, the sponsor was only interested in the estimated LVEF. CVMETHOD shows the evaluation method of LVEF. Information from the multigated acquisition (MUGA) scan could be represented in the Procedures (PR) domain, as appropriate.

cv.xpt

cv.xpt

Row

STUDYID

DOMAIN

USUBJID

CVSEQ

CVTESTCD

CVTEST

CVORRES

CVORRESU

CVSTRESC

CVSTRESN

CVSTRESU

CVMETHOD

VISITNUM

VISIT

CVDTC

1AAA123CV0011LVEF_ELeft Ventricular Ejection Fraction, Est

20

%

20

20%MUGA1SCREENING2019-06-01

The HO domain was used to indicate whether the subject had any hospital stays in the 6 months prior to study enrollment and to represent details of those hospitalizations. The healthcare encounter—in this case, a hospital stay—is represented using HOTERM. Because the collection date was not recorded on the CRF, the sponsor assigned HODTC as the date of the screening visit; HODTC provides the timing information relative to the evaluation interval.

ho.xpt
Row 1:

Shows the subject was hospitalized in the last 6 months. NSHO.HOINDC was used to indicate that this hospitalization was for worsening heart failure. NSHO.HOCRNORD was used to indicate that this was the most recent hospitalization in the last 6 months

Row 2:Shows the subject was not hospitalized in the last 6 months.

ho.xpt

RowSTUDYIDDOMAINUSUBJIDHOSEQHOTERMHOPRESPHOOCCURHODTCHOSTDTCHOENDTCHOEVLINT
HOINDCHOCRNORD
1AAA123HO0011HOSPITALYY2019-06-01

2019-05-15

2019-05-17

-P6M
WORSENING HEART FAILUREMOST RECENT
2AAA123HO0021HOSPITALYN2019-07-14

-P6M
WORSENING HEART FAILURE

HO NSV Metadata

This dataset shows information on prior use of intravenous diuretics.

cm.xpt

Row 1:

Shows whether the subject had any prior use of intravenous diuretics. This general row about diuretics was included to represent both the presence and absence of a medication. This allows the sponsor to summarize the data on the usage of intravenous diuretics.

Row 2:

Shows that the subject was administered DIURETIC A on the dates specified.

cm.xpt

RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMPRESPCMOCCURCMINDCCMROUTECMDTCCMSTDTCCMENDTCCMSTDYCMENDY
1AAA123CM0011

DIURETIC

PRIOR HEART FAILURE MEDICATIONYYACUTE ON CHRONIC SYSTOLIC HEART FAILUREINTRAVENOUS2019-06-01



2AAA123CM0012

DIURETIC A

PRIOR HEART FAILURE MEDICATION

ACUTE ON CHRONIC SYSTOLIC HEART FAILUREINTRAVENOUS
2019-05-152019-05-16-17-16