. Author manuscript; available in PMC: 2013 May 24.

Published in final edited form as: J Am Coll Cardiol. 2010 Aug 24;56(9):692–699. doi: 10.1016/j.jacc.2010.03.068

Table 1. Composite Cardiovascular Score.

Status	Definition

Worsened	Any of the following conditions occur after randomization All cause death Occurrence of one or more of the following primary CV events: exacerbation of heart failure acute myocardial infarction atrial/ventricular arrhythmia unstable angina cardiac syncope transient ischemic attack stroke/cardiovascular accident complications of cardiac medications or cardiac procedures Permanent discontinuation of double-blind study drug due to CV reasons Permanent discontinuation of double-blind study drug because of refusal to participate, withdrawal of consent, or other administrative reasons AND at least one of the following occurred during the post-randomization period primary CV event on or prior to discontinuation of double-blind study drug increase of NYHA class on or prior to discontinuation of double-blind study drug death within 7 days following discontinuation of double-blind study drug

Improved	The criteria for “worsened” has not been previously met AND at least one of the following conditions occurred at the last assessment completed during the post-randomization period: Improvement in NYHA functional class Heart failure status (as determined by the clinician CGI-I score) is judged to be moderately-to-markedly improved

Unchanged	Participant is neither improved or worsened