Heart Failure Medical History

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.

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.

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.

This dataset shows information on prior use of intravenous diuretics.