biostudies-literatureFanaroff ACNHLBI NIH HHS863-873https://www.ebi.ac.uk/biostudies/studies/S-EPMC6370494biostudies-literatureUnknown139(7)<h4>Background</h4>Modern cardiometabolic clinical trials often include cardiovascular death as a component of a composite primary outcome, requiring central adjudication by a clinical events committee to classify cause of death. However, sometimes the cause of death cannot be determined from available data. The US Food and Drug Administration has indicated that this circumstance should occur only rarely, but its prevalence has not been formally assessed.<h4>Methods</h4>Data from 9 global clinical trials (2009-2017) with long-term follow-up and blinded, centrally adjudicated cause of death were used to calculate the proportion of deaths attributed to cardiovascular, noncardiovascular, or undetermined causes by therapeutic area (diabetes mellitus/pre-diabetes mellitus, stable atherosclerosiCirculationFrequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials.PMC6370494T32 HL069749R01 HL093071Green JBPieper KSMoreira HGClare RFanaroff ACMahaffey KWJones WSAl-Khatib SMHeld CHolman RRRoe MTMehta RHTricoci PMathews RAlexander JHAlexander KPCaliff RMPovsic TJLopes RDWallentin LHarrison RWMelloni CKong DFfalseFrequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials.<h4>Background</h4>Modern cardiometabolic clinical trials often include cardiovascular death as a component of a composite primary outcome, requiring central adjudication by a clinical events committee to classify cause of death. However, sometimes the cause of death cannot be determined from available data. The US Food and Drug Administration has indicated that this circumstance should occur only rarely, but its prevalence has not been formally assessed.<h4>Methods</h4>Data from 9 global clinical trials (2009-2017) with long-term follow-up and blinded, centrally adjudicated cause of death were used to calculate the proportion of deaths attributed to cardiovascular, noncardiovascular, or undetermined causes by therapeutic area (diabetes mellitus/pre-diabetes mellitus, stable atherosclerosi2019-01-01T00:00:00Z2019 Feb2025-04-04T12:29:41.995Z2020-10-29T17:14:29ZS-EPMC63704943058673910.1161/CIRCULATIONAHA.118.03720210.1161/circulationaha.118.037202