History of cardiac disease: congestive heart failure (CHF) > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > Class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
History of cardiac disease: congestive heart failure (CHF) > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction or coronary stenting within 6 months prior to randomization; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (angina symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure-New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
unstable angina (anginal symptoms at rest) or new onset angina (i.e., began within the last 3 months).
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease including unstable or newly diagnosed angina or myocardial infarction within 6 months prior to study entry\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Corrected QT interval (QTc) (Fridericia) > 450 msec on two consecutive electrocardiograms (ECGs) (baseline ECG should be repeated if QTc is found to be > 450 msec)
FOR ALL PHASES (Ib AND II): History of significant cardiac disease:\r\n* Congestive heart failure > New York Heart Association (NYHA) class 2\r\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) \r\n* Myocardial infarction less than 6 months before start of test drug\r\n* Anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Suspected long QT syndrome defined as corrected QT (QTc) interval > 500 milliseconds at baseline\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Pre-existing cardiac conditions as outlined below:\r\n* Congestive heart failure >= New York Heart Association (NYHA) class 2\r\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months); myocardial infarction less than 6 months before the start of study treatment\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Patients with cardiac disease defined as one of the following are not eligible:\r\n* Congestive heart failure > class II New York Heart Association (NYHA)\r\n* Unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months)\r\n* Myocardial infarction within the past 6 months
Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* New York Heart Association (NYHA) class III or IV congestive heart failure
Active or clinically significant (or symptomatic) cardiac disease, including active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin within the last 3 months, unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before study day 0
Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (e.g., anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* Ventricular arrhythmias requiring anti-arrhythmic therapy other than beta blockers\r\n* New York Heart Association (NYHA) class III or IV congestive heart failure
Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers\r\n* New York Heart Association (NYHA) class III or IV congestive heart failure
Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
History or current condition of an uncontrolled cardiovascular disease including congestive heart failure NYHA > Class 2, unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months) or myocardial infarction within past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).
History or current evidence of uncontrolled cardiovascular disease including, but not limited to, the following conditions:\r\n* Congestive heart failure of New York Heart Association (NYHA) class III or IV\r\n* Unstable angina (symptoms of angina at rest) or new-onset angina =< 6 months before the start of anetumab ravtansine
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* Cardiac arrhythmias currently requiring anti-arrhythmic therapy other than beta blockers
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (angina symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Subjects who have a history or current evidence of uncontrolled cardiovascular disease including but not limited to the following conditions:\r\n* Congestive heart failure of New York Heart Association (NYHA) class III or IV\r\n* Unstable angina (symptoms of angina at rest) or new-onset angina within < 3 months before the start of study treatment\r\n* Arterial thrombosis, deep vein thrombosis, or pulmonary embolism within < 3 months before the start of study treatment\r\n* Myocardial infarction or stroke within < 3 months before the start of study treatment\r\n* Pericarditis (any CTCAE grade), pericardial effusion (CTCAE grade >= 2) or pleural effusion (CTCAE grade >= 2)\r\n* Cardiac arrhythmia requiring anti-arrhythmic therapy; subjects receiving digoxin, calcium channel blockers except verapamil, or beta-adrenergic blockers except propranolol are eligible at the investigator’s discretion if the dose has been stable for at least 2 weeks before the start of study treatment; subjects with sinus arrhythmia and infrequent premature ventricular contractions are eligible at the investigator’s discretion
Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure - New York Heart Association (NYHA) > class II\r\n* Coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina or new-onset angina within 3 months before randomization, or myocardial infarction (MI) within 6 months before randomization
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure - New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Left ventricular function < 50%\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization\r\n* Patients who have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy\r\n* Patients who are receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents; once-daily aspirin (maximum dose 325 mg/day) is permitted
Active or clinically significant cardiac disease including: \r\n* Congestive heart failure - New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Active or clinically significant cardiac disease including: \r\n* Congestive heart failure - New York Heart Association (NYHA) > class II \r\n* Active coronary artery disease that is not medically treated\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before registration, or myocardial infarction within 6 months before registration
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class >II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months before study entry), myocardial infarction within the past 3 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted).
Active or clinically significant cardiac disease including: \r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina < 3 months before randomization, or myocardial infarction within 6 months before randomization
History of clinically significant cardiac disease or congestive heart failure > New York Heart Association (NYHA) class 2; patients must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months, or myocardial infarction within 6 months
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure - New York Heart Association (NYHA) > class II;\r\n* Active coronary artery disease that is not medically treated;\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
History of cardiac disease: congestive heart failure (CHF) > NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy
History of cardiac disease: congestive heart failure (CHF) > NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy
Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure-New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before treatment, or myocardial infarction within 6 months before treatment
Active cardiac disease including any of the following:\r\n* Congestive heart failure (New York Heart Association [NYHA]) >= class 2\r\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months); myocardial infarction less than 6 months before start of day 1 of irinotecan\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before study entry
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Corrected QT (QTc) > 500 ms\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Active cardiac disease including any of the following: \r\n* Congestive heart failure (New York Heart Association [NYHA]) >= class 2\r\n* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months); myocardial infarction less than 6 months before start of day 1 of FOLFIRI\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)\r\n* Uncontrolled hypertension; (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
Has active or clinically significant cardiac disease including:\r\n* Congestive heart failure - New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before initiation, or myocardial infarction within 6 months before initiation
Congestive heart failure > New York Heart Association (NYHA) class 2: unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before study registration; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
History of clinically significant cardiac disease or congestive heart failure > New York Heart Association (NYHA) class 2. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.
No uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris or new onset angina that began within the last 3 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
History of cardiac disease including congestive heart failure New York Heart Association (NYHA) Class >II (Section 14.7), unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (eg angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography)
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure-New York Heart Association (NYHA) > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association (NYHA) > class II\r\n* Uncontrolled cardiac arrhythmias despite optimal management\r\n* Unstable angina (anginal symptoms at rest), new-onset angina, myocardial infarction within 3 months of initiation of treatment on trial
Have congestive heart failure classified as New York Heart Association Class 2 or higher.Have had unstable angina (angina symptoms at rest) or new-onset angina ? 3 months prior to screening. Have had a myocardial infarction < 6 months prior to initiation of study treatment.
Serious illness including, significant ongoing or active infection, New York Heart Association (NYHA) grade III or IV congestive heart failure, unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within past 3 months; serious medical or psychiatric illness/social situations that in the opinion of the investigator would limit compliance with study requirements
Congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class > II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months before study entry), myocardial infarction within the past 3 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted)
Subject with uncontrolled cardiac disease including congestive heart failure class III or IV by the NYHA, unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
History of cardiac disease including congestive heart failure New York Heart Association (NYHA) Class >/=III, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months or cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. major regional wall motion abnormalities on baseline echocardiography or a left ventricular ejection fraction (LVEF) <45%)
History of cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography)
Patients must not have cardiac disease defined as: New York Heart Association (NYHA) > class II; patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Active or clinically significant cardiac disease including:\r\n* Congestive heart failure – New York Heart Association > class II\r\n* Active coronary artery disease\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before registration, or myocardial infarction within 6 months before registration
Cardiac disease:\r\n* Congestive heart failure > class II New York Heart Association (NYHA), or\r\n* Unstable angina (anginal symptoms at rest), or new-onset angina (begun within the last 3 months), or myocardial infarction within the 6 months prior to enrollment, or \r\n* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\r\n* Congenital long QT syndrome or taking drugs known to prolong the QT interval\r\n* Subjects taking any drugs with a known risk of causing torsades de pointes
Congestive heart failure > class II New York Heart Association (NYHA); unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA): unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months, or uncontrolled arrhythmia
History of cardiac disease congestive heart failure (CHF) > NYHA Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or Digoxin are permitted).
Congestive heart failure > class II New York Heart Association (NYHA); patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina pectoris (defined as anginal symptoms at rest, new-onset angina within 3 months before study treatment initiation, or myocardial infarction within 6 months before study treatment initiation), cardiac arrhythmia (which require anti-arrhythmic therapy other than beta blockers or digoxin), active coronary artery disease, or psychiatric illness/social situations that would limit compliance with study requirements
Active or clinically significant cardiac disease including: a. congestive heart failure-New York Heart Association (NYHA) > class II; b. active coronary artery disease; c. cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin; d. unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
History of cardiac disease, including congestive heart failure of New York Heart Association (NYHA) class >II, unstable angina (anginal symptoms at rest) or new-onset angina (within 6 months prior to study entry), myocardial infarction within 6 months prior to study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography or multiple-gated acquisition [MUGA] scan). Patients with a pacemaker are also excluded