Has had known clinically significant cardiovascular disease within 12 months of planned start of study drug, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
Has had clinically significant cardiovascular disease within 12 months of start of study drug, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
Clinically significant cardiovascular disease within 12 months prior to enrollment/randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication or placement of percutaneous transluminal coronary angioplasty/stent
Uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months before enrollment, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication.
Uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months before enrollment, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication.
Any of the following within the 6 months prior to study drug administration: myocardial infarction, grade 2 or greater peripheral vascular disease, arterial thrombotic event, visceral arterial ischemia, cerebrovascular ischemia, transient ischemic attack, percutaneous transluminal angioplasty or stent, or unstable angina
Clinically significant cardiovascular disease within 12 months prior to enrollment/randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication or placement of percutaneous transluminal coronary angioplasty/stent
Angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism , pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within 6 months prior to randomization. Deep venous thrombosis within 3 months prior to randomization unrelated to a central venous catheter, unless the patient is anti-coagulated without the use of warfarin for at least 2 weeks prior to randomization. In this situation, low molecular weight heparin is preferred
A history of cardiovascular diseases: unstable angina, myocardial infarction, or known congestive heart failure class IIIV within the preceding 12 months; cerebrovascular accident or transient ischemic attack within the preceding 3 months, pulmonary embolism within the preceding 2 months
Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, PTCA or CABG within the past 6 months.
Any of the following cardiovascular history in the past 6 months: myocardial infarction, unstable angina, coronary/ peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, symptomatic bradycardia, requirement for anti-arrhythmic medication.
Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
Any of the following in the previous 6 months:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Coronary/peripheral artery bypass graft\r\n* Symptomatic congestive heart failure\r\n* Cerebrovascular accident\r\n* Transient ischemic attack\r\n* Symptomatic pulmonary embolism
Patient must not have a history of the following within 6 months prior to cycle 1 day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack
Have experienced any of the following within the 6-month period prior to Screening: unstable angina pectoris, clinically significant coronary artery disease, cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia
Subjects with the following cardiac risk factors must be excluded: transmural myocardial infarction (MI) within prior 6 months, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack (TIA) or seizure disorder within 6 months prior to study drug administration; in addition, patients with New York Heart Association (NYHA) class III or IV heart failure will be excluded
Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
Diagnosis with any of the following in the 12 months prior to registration: severe/unstable angina, myocardial infarction, uncontrolled cardiac arrhythmia, congestive heart failure, cerebrovascular accident or transient ischemic attack
Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack
Cardiac exclusions specific to glasdegib and OX40 containing arms: Any one of the following ongoing or in the previous 6 months: congenital long QT syndrome, torsades de pointes, sustained ventricular tachyarrhythmia, right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident (CVA), transient ischemic attack or symptomatic pulmonary emboli, as well as bradycardia defined as < 50 beats per minute (bpm)s. Active cardiac dysrhythmias of NCI CTCAE grade >= 2 (eg, atrial fibrillation) or corrected QT (QTc) interval > 470 msec.
Any of the following within 6 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection; any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
Within the past 6 months, has had any of the following: pleural effusion, myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack
Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack
History of the following within the prior 6 months: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack
Any of the following within 6 months of registration: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism; no QTc interval > 480 msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or torsade de pointes
Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
CAPMATINIB EXCLUSION CRITERIA: Any of the following in the past 6 months prior to screening:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Clinically significant cardiac arrhythmias\r\n* Cerebrovascular accident or transient ischemic attack\r\n* Coronary/peripheral artery bypass graft
CERITINIB EXCLUSION CRITERIA: Any of the following in the past 6 months prior to screening:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Clinically significant cardiac arrhythmias\r\n* Cerebrovascular accident or transient ischemic attack\r\n* Coronary/peripheral artery bypass graft
REGORAFENIB EXCLUSION CRITERIA: Any of the following in the past 6 months prior to screening:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Clinically significant cardiac arrhythmias\r\n* Cerebrovascular accident or transient ischemic attack\r\n* Coronary/peripheral artery bypass graft
ENTRECTINIB EXCLUSION CRITERIA: Any of the following in the past 6 months prior to screening:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Clinically significant cardiac arrhythmias\r\n* Cerebrovascular accident or transient ischemic attack\r\n* Coronary/peripheral artery bypass graft
Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE grade >= 2, symptomatic congestive heart failure, or cerebrovascular accident excluding transient ischemic attack
Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery (CABG) within the past 6 months; deep venous thrombosis within 6 months, unless the patient is anticoagulated without the use of warfarin for at least 2 weeks; in this situation, low molecular weight heparin is preferred
Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
Severe cardiovascular disease within 6 months, including myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebro-vascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias, uncontrollable hypertension or QT prolongation syndrome
Patients with symptomatic congestive heart failure, unstable angina or myocardial infarction, coronary/peripheral artery bypass graft or repair, cerebrovascular accident or transient ischemic attack in the 12 months prior to randomization; or deep vein thrombosis or pulmonary embolism in the 6 months prior to randomization
Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within twelve (12) months prior to screening
Any of the following: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE grade >= 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, uncontrolled seizures or brain metastases or pulmonary embolism.
Any of the following within 6 months prior to first dose of treatment: myocardial infarction, symptomatic coronary artery disease (severe or unstable angina), artery bypass graft, uncontrolled arrhythmias, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolus
History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.7. Treatment with any investigational product within 28 days prior to signing Informed Consent Form.
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade ?2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
Any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of Grade greater than or equal to (>/=) 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident including transient ischemic attack
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack
Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, deep vein thrombosis or symptomatic pulmonary embolism.
Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
Patients with any of the following conditions are excluded:\r\n* Serious or non-healing wound, ulcer, or bone fracture\r\n* History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days of treatment\r\n* Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry\r\n* History of myocardial infarction, ventricular arrhythmia, stable/unstable angina, symptomatic congestive heart failure, coronary/peripheral artery bypass graft or stenting or other significant cardiac disease within 12 months prior to study entry\r\n* Any history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within the past 12 months\r\n* Any episode of atrial fibrillation in the prior 12 months
In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
Any of the following within the preceding 6 months- myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass, graft, cerebrovascular accident or transient ischemic attack, clinically significant bleeding
Any of the following within 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and within 6 months before study drug administration for deep vein thrombosis or pulmonary embolism
Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of screening
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event
E 10. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack.
Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
Any one of the following currently or in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack; symptomatic pulmonary embolism; congenital long QT syndrome, torsades de points, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, atrial fibrillation of any grade, or QTc interval >470 msec at screening.
Uncontrolled hypertension (blood pressure >150/100 mmHg despite optimal medical therapy) or any of the following within 12 months prior to registration: myocardial infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac dysrhythmias, atrial fibrillation or QTcF interval >470 msec.
Any of the following within 6 months prior to study entry:\r\n* Myocardial infarction (MI)\r\n* Severe/unstable angina\r\n* Coronary artery bypass graft (CABG)\r\n* Congestive heart failure (CHF) > New York Heart Association (NYHA) II\r\n* Cerebrovascular accident (CVA)\r\n* Transient ischemic attack (TIA)\r\n* Pulmonary embolism (PE)
Subject has a history of a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, seizure disorder or clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, within 6 months prior to Cycle 1 Day 1.
Cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 12 weeks prior to Baseline.
SUNITINIB MALATE ARM: Patients with any of the following conditions are excluded:\r\n* Serious or non-healing wound, ulcer, or bone fracture\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment\r\n* Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry\r\n* History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry\r\n* History of pulmonary embolism within the past 12 months
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism
Patients with clinically significant cardiovascular or cerebrovascular disease:\r\n* History of cerebrovascular accident or transient ischemic attack within past 6 months from registration\r\n* Myocardial infarction, coronary artery bypass grafting (CABG) or unstable angina within the past 6 months from registration\r\n* New York Heart Association grade III or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris within past 6 months from registration\r\n* Clinically significant peripheral vascular disease within past 6 months from registration
Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism
History of the following within 6 months prior to first administration of investigational product: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
Any of the following within 6 months prior to study entry: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack
Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy
Any of the following within 3 months prior to study drug administration: myocardial infarction, unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or severe uncontrolled ventricular arrhythmia.
Any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
Severe/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction.
Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the past 6 months. Deep venous thrombosis within 6 months, unless the patient is therapeutically anti-coagulated for at least 2 weeks. In this situation, low molecular weight heparin is preferred
History of any of the following within the last 6 months prior to study entry:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures  \r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia) \r\n* Pulmonary embolism\r\n* New York Heart Association (NYHA) class III or IV heart failure \r\n* Placement of a pacemaker for control of rhythm
Patients with a history of the following within =< 6 months of study entry are NOT eligible:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* New York Heart Association (NYHA) class III or IV heart failure\r\n* Pulmonary embolism
History of any of the following within the last 6 months prior to study registration:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* New York Heart Association (NYHA) class III or IV heart failure \r\n* Pulmonary embolism
Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures
Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures
History of any of the following within the last 6 months prior to study entry:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* New York Heart Association (NYHA) class III or IV heart failure\r\n* Pulmonary embolism
History of any of the following within the last 6 months before administration of the first dose of the drug: a) Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures b) Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures c) Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia) d) Placement of a pacemaker for control of rhythm e) New York Heart Association (NYHA) class III or IV heart failure f) Pulmonary embolism.
Ischemic myocardial event including angina requiring therapy and artery revascularization procedures, myocardial infarction, and unstable symptomatic ischemic heart disease.
Ischemic cerebrovascular event, including transient ischemic attack and artery, revascularization procedures.
Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures.
Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures.
History of any of the following within the last 6 months prior to study entry: ischemic myocardial event, including angina requiring therapy and artery revascularization procedures; ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures; requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia); placement of a pacemaker for control of rhythm; New York Heart Association (NYHA) class III or IV heart failure; pulmonary embolism
History of any of the following within the last 6 months before administration of the first dose of the drug:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* New York Heart Association (NYHA) class III or IV heart failure\r\n* Pulmonary embolism
History of any of the following within the last 6 months prior to study entry: ischemic myocardial event, including angina requiring therapy and artery revascularization procedures; ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures; requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia); placement of a pacemaker for control of rhythm; New York Heart Association (NYHA) class III or IV heart failure; pulmonary embolism
History of any of the following within the last 6 months before administration of the\r\nfirst dose of the drug:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* New York Heart Association (NYHA) class III or IV heart failure\r\n* Pulmonary embolism
History of any of the following within the last 6 months prior to study entry:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* New York Heart Association (NYHA) class III or IV heart failure\r\n* Pulmonary embolism
The subject has a history of any of the following within the last 6 months before administration of the first dose of the drug:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* New York Heart Association (NYHA) class III or IV heart failure\r\n* Significant active cardiovascular or pulmonary disease including:\r\n** Uncontrolled hypertension defined as sustained blood pressure (BP) > 160 mm Hg systolic or > 95 mm Hg diastolic despite optimal antihypertensive treatment\r\n** Pulmonary hypertension\r\n** Uncontrolled asthma or O2 saturation < 90% by arterial blood gas analysis or pulse oximetry on room air\r\n** Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n** History of arrhythmia requiring an implantable cardiac defibrillator\r\n** Medically significant (symptomatic) bradycardia
History of any of the following within the last 6 months prior to study entry:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* Pulmonary embolism
Ischemic myocardial event including angina requiring therapy and artery revascularization procedures
Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures
Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures;
Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures;
History of any of the following within the last 6 months prior to study entry:\r\n*Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* New York Heart Association (NYHA) class III or IV heart failure \r\n* Pulmonary embolism
History of any of the following within the last 6 months before administration of the first dose of the drug:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures,\r\n* Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures,\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia),\r\n* Placement of a pacemaker for control of rhythm,\r\n* New York Heart Association (NYHA) class III or IV heart failure, -Pulmonary embolism
Patients with a history of any of the following within the last 6 months prior to study entry are ineligible:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* New York Heart Association (NYHA) class III or IV heart failure\r\n* Pulmonary embolism