Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial.

ABSTRACT:

Background

Adjudicated cause-specific mortality has been used in major trials of chronic obstructive pulmonary disease. However, there is less experience with adjudicated major adverse cardiovascular events as a key efficacy outcome in chronic obstructive pulmonary disease trials. The Study to Understand Mortality and Morbidity in chronic obstructive pulmonary disease trial required a Clinical Endpoint Committee to adjudicate the outcomes of modified major adverse cardiovascular events and cause-specific mortality.

Methods and results

A six-member Clinical Endpoint Committee reviewed adverse event and serious adverse event reports included in a list of 204 Medical Dictionary for Regulatory Activities terms. Adverse events were triaged by one Clinical Endpoint Committee membe

SUBMITTER: Wise RA 

PROVIDER: S-EPMC7416329 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature