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.
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.
Shows the date of the most recent episode of worsening heart failure in the last 6 months (MHEVLINT = -P6M).
|1||AAA123||MH||001||1||HEART FAILURE WITH REDUCED EJECTION FRACTION||Heart failure with reduced ejection fraction||Cardiac failure||DIAGNOSIS||HEART FAILURE HISTORY||Y||Y||2018-04-21||CORONARY ARTERY DISEASE||ISCHEMIC|
|2||AAA123||MH||001||2||WORSENING HEART FAILURE||Cardiac failure aggravated||Cardiac failure||EPISODE||HEART FAILURE HISTORY||Y||Y||2018-05-15||-P6M||MOST RECENT|
MH NSV Metadata
|MHPRC||Primary Cause||text||Non-standard Record Qualifier||CRF|
|MHETOLGY||Etiology||text||Non-standard Record Qualifier||CRF|
|MHCRNORD||Chronological Order||text||Non-standard Timing Variable||CRF|
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.
|1||AAA123||CV||001||1||LVEF_E||Left Ventricular Ejection Fraction, Est|
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.
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.|
|-P6M||WORSENING HEART FAILURE||MOST RECENT|
|2||AAA123||HO||002||1||HOSPITAL||Y||N||2019-07-14||-P6M||WORSENING HEART FAILURE|
HO NSV Metadata
|text||Non-standard Record Qualifier||CRF|
|HOCRNORD||Chronological Order||text||Non-standard Timing Variable||CRF|
This dataset shows information on prior use of intravenous diuretics.
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.
Shows that the subject was administered DIURETIC A on the dates specified.
|PRIOR HEART FAILURE MEDICATION||Y||Y||ACUTE ON CHRONIC SYSTOLIC HEART FAILURE||INTRAVENOUS||2019-06-01|
|PRIOR HEART FAILURE MEDICATION||ACUTE ON CHRONIC SYSTOLIC HEART FAILURE||INTRAVENOUS||2019-05-15||2019-05-16||-17||-16|