Free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia; the ejection fraction by gated cardiac blood flow scan (MUGA) or echocardiogram must be > 40%
Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%; for children that are not able to cooperate with multi-gated acquisition (MUGA) and echocardiography, such should be clearly stated in the physician’s note
Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction >= 40%; for children that are not able to cooperate with multi-gated acquisition scan (MUGA) and echocardiography, such should be clearly stated in the physician’s note
Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction >= 35%
Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction >= 35% OR fractional shortening > 22%
Adequate cardiac function defined as absence of decompensated congestive heart failure, or uncontrolled arrhythmia and:\r\n* Left ventricular ejection fraction >= 35% or\r\n* Fractional shortening > 22%
Patients must be free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia
Cardiac: absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction >= 35%; for children that are not able to cooperate with multi gated acquisition scan (MUGA) and echocardiography, such should be clearly stated in the physician’s note
Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 45%; for children not able to cooperate with multigated acquisition (MUGA) or echocardiography, such should be clearly stated in the physician’s documentation
Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ? 40%
Within 30 days of registration: Absence of clinical decompensated congestive heart failure or uncontrolled arrhythmia
No decompensated congestive heart failure (CHF), or uncontrolled arrhythmia; ejection fraction (EF) >= 35%
Patients must be free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia; the ejection fraction by multi-gated acqusition scan (MUGA) must be > 45%
No decompensated congestive heart failure (CHF), or uncontrolled arrhythmia
Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction >= 40%
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Patients with a history of myocardial infarction or unstable angina =< 6 months prior to registration or congestive heart failure (CHF) requiring use of ongoing maintenance therapy, or life-threatening ventricular arrhythmias
History of myocardial infarction =< 12 months prior to registration, severe/unstable angina, systematic congestive heart failure (CHF) New York Heart Association classification III or IV or CHF requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 180 days prior to registration or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction ? 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 180 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Absence of history of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 180 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 180 days prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 168 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Clinically significant cardiac disease, especially history of myocardial infarction =< 6 months, or congestive heart failure (New York Heart Association [NYHA] classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months from registration, or congestive heart failure requiring use of ongoing maintenance therapy for life threatening ventricular arrhythmias
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 6 months prior to registration, unstable angina, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of myocardial infarction =< 180 days prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmia
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of congestive heart failure
No congestive heart failure (CHF) within 182 days of registration
Active congestive heart failure or ventricular arrhythmia requiring medication
Congestive heart failure
Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
Testing for LVEF is not required for pre-registration, but patient must not have a recent LVEF < LLN or have symptoms of congestive heart failure
Symptomatic congestive heart failure
Congestive heart failure (CHF) since axitinib can cause CHF
History of pulmonary edema or decompensated congestive heart failure with in six (6) week of enrollment.
Symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance
Current symptomatic congestive heart failure or history of symptomatic congestive heart failure in the preceding 3 months, defined as New York (NY) Heart Association classification 2- 4
Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the investigator (e.g., uncontrolled congestive heart failure, active infection, etc.);
Patients with history of congestive heart failure stage III or greater
For participants with congestive heart failure, cardiovascular-related hospitalizations within 4 weeks prior to randomization
Patients with history of congestive heart failure stage III or greater
Symptomatic valvular heart disease
Symptomatic congestive heart failure
Been treated with appropriate maximal medical therapy for heart failure
Patients with history of congestive heart failure are excluded
Symptomatic heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction or symptomatic congestive heart failure
Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction or symptomatic congestive heart failure
Subject with significant congestive heart failure (CHF) or history of CHF, chronic renal failure, hepatic failure, neuropathy
Significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease
Previous hospitalization due to documented heart failure in the last 12 months
Congestive heart failure < 6 months prior to screening
Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, or symptomatic congestive heart failure; also patients with a history of myocardial infarction that is < 1 year prior to registration, or patients with previous congestive heart failure (< 1 year prior to registration) requiring pharmacologic support or with left ventricular ejection fraction < 50%
Presence of a symptomatic bradyarrhythmia or uncompensated heart failure
Congestive heart disease not controlled by medication.
Congestive heart failure (CHF) within 6 months prior to first dose;
No acute congestive heart failure
Current clinical heart failure or symptomatic ischemic heart disease
History of myocardial infarction =< 6 months, or current symptomatic congestive heart failure or left ventricular ejection fraction (LVEF) < 40% or with > grade 2 diastolic dysfunction, with no symptoms or signs of heart failure
Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
Congestive heart failure requiring medication (other than diuretic)
Active ischemic heart disease or congestive heart failure
Been treated with appropriate maximal medical therapy for heart failure
Serious intercurrent medical illness (e.g., symptomatic congestive heart failure)
Has a history of significant congestive heart failure or significant pulmonary disease
Symptomatic congestive heart failure (CHF)
Absence of clinically significant cardiomyopathy, congestive heart failure
Absence of clinically significant cardiomyopathy, congestive heart failure
Previous history of congestive heart failure
The participant has symptomatic congestive heart failure or symptomatic cardiac arrhythmia.
Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months.
Active congestive heart failure or ventricular arrhythmia requiring medication
No congestive heart failure < 6 months
Known active symptomatic congestive heart failure
Patients with symptoms of congestive heart failure are not eligible
History of congestive heart failure or other findings of ventricular dysfunction
Symptomatic congestive heart failure
Known congestive heart failure requiring medical management
History of congestive heart failure or systolic dysfunction (LVEF <50%)
History of symptomatic congestive heart failure within 6 months prior to the initiation of therapy on this protocol
Congestive heart failure (CHF) within 6 months prior to first dose
Evidence of uncontrolled congestive heart failure
Symptomatic congestive heart failure
History of congestive heart failure (CHF)
Has symptomatic congestive heart failure (CHF)
Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, or symptomatic congestive heart failure; also patients with a history of myocardial infarction that is < 1 year prior to registration, or patients with previous congestive heart failure (< 1 year prior to registration) requiring pharmacologic support or with left ventricular ejection fraction < 45%
Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, or symptomatic congestive heart failure
Uncompensated congestive heart failure
Non-controlled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable chest angina or heart arrhythmia, as well as mentally incapable patients
Grade 2 or greater congestive heart failure
History of hospitalization for Congestive Heart Failure
Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible
Severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
Patients cannot have known cardiac disease (either arrhythmia or congestive heart failure) requiring treatment
Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction or symptomatic congestive heart failure
Serious intercurrent medical illness (e.g., symptomatic congestive heart failure)
Patients with congestive heart failure or significant arrhythmia
Symptomatic congestive heart failure
Congestive heart failure.
History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
History of congestive heart failure;
Patients with history of congestive heart failure
Symptomatic congestive heart failure
History of congestive heart failure (CHF)
Active symptomatic congestive heart failure
Congestive heart failure (CHF) currently requiring therapy
Active congestive heart failure or ventricular arrhythmia
Symptomatic congestive heart failure;
Congestive heart failure (CHF) currently requiring therapy
No evidence of clinically significant congestive heart failure, (ejection fraction of 45% or greater)
Has an active infection, congestive heart failure, slow heart rate, or other uncontrolled disease other than cancer
Active heart disease
Unstable congestive heart failure
History or current symptoms of congestive heart failure (shortness of breath, ankle swelling)
Clinical diagnosis of congestive heart failure and/or pulmonary capillary wedge pressure >15 mmHg, or uncorrected congenital heart disease.
Congestive heart failure,
Active symptomatic congestive heart failure
Congestive heart failure requiring medication (other than diuretic)
History of or active ventricular dysrhythmias or congestive heart failure requiring medication or symptomatic coronary heart disease
Extremity edema due to heart failure
Patients with history of congestive heart failure
Congestive heart failure
Congestive heart failure
Receiving treatment for cardiomyopathy or congestive heart failure
History of congestive heart failure and ejection fraction less than 35%
History of congestive heart failure; systolic heart failure defined as ejection fraction (EF) =< 40%, or diastolic heart failure defined as EF > 40% PLUS systemic manifestation of heart failure
Congestive heart failure (CHF)
Patients with history of congestive heart failure
No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease
Documentation of congestive heart failure and ejection fraction < 30% if recorded in the pre-operative record
Any patient with known ischemic heart disease, history of congestive heart failure, history of stroke, or cardiac arrhythmia for which the patient requires medication or a medical device
Congestive heart failure refractory to medical management
NYHA stage 3 or 4 congestive heart failure
Conditions that could cause swelling (e.g., pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis, or deep vein thrombosis in arms
Known heart disease
Known heart disease
Patients with congestive heart failure requiring pharmacological management
Participant reported history of congestive heart failure
Congestive heart failure
Liver impairment or congestive heart failure
Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy
congestive heart failure
History of renal disease, hypertension, diabetes, congestive heart failure or emphysema
> stage 3 heart failure
Worsening of or clinically unstable congestive heart failure
Congestive heart failure, clinically significant
History of congestive heart failure
History of clinically significant congestive heart failure
Participants with history of hypertension, congestive heart failure, edema, stroke or other cardiac disease or condition
Patients with history of congestive heart failure
Symptomatic congestive heart failure.
Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria and who do not receive a physician clearance to participate in the moderate intensity physical activity with one or more of the following self-reported conditions:\r\n* heart attack\r\n* heart surgery, cardiac catherization, or coronary angioplasty\r\n* pacemaker/implantable cardiac defibrillator/rhythm disturbance\r\n* heart valve disease \r\n* heart failure \r\n* heart transplantation \r\n* congenital heart disease \r\n* diabetes \r\n* kidney (renal) disease\r\n* chest discomfort with exertion \r\n* unreasonable breathlessness \r\n* dizziness, fainting or blackouts \r\n* ankle swelling \r\n* unpleasant awareness of forceful, rapid or irregular heart rate \r\n* burning or cramping sensations in your lower legs when walking short distance
EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke within the last 3 months, or a diagnosis of congestive heart failure
EXCLUSION CRITERIA FOR THIRD-LINE THERAPY: Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke within the last 3 months, or a diagnosis of congestive heart failure
Cardiovascular disease including unstable angina; therapy for life-threatening cardiac arrhythmia, myocardial infarction, stroke; or NYHA Class III or IV congestive heart failure within the last 3 months prior to initiation of study treatment
Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
Cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
Cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
Subjects with reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening;
Significant history of uncontrolled cardiac disease defined as uncontrolled arrhythmias, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure or any class 2 - 4 New York Heart Association classification cardiac disease
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or Qtc >480 msec
Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association functional classification
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association functional classification, or history of myocardial infarction within 6 months prior to first dose with study drug
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) > 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 2 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 2 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, QT prolongation or familial history of QT prolongation, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 2 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association functional classification
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
Relapsed/refractory MCL: Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months at the time of consent or any class 3 (moderate) or 4 (severe) cardiac disease defined by the New York Heart Association classification
Newly diagnosed MCL: Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months at the time of consent or any class 3 (moderate) or 4 (severe) cardiac disease defined by the New York Heart Association Classification
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months at the time of consent or any class 3 (moderate) or 4 (severe) cardiac disease defined by the New York Heart Association classification.
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months at the time of consent or any class 3 (moderate) or 4 (severe) cardiac disease defined by the New York Heart Association classification.
Significant cardiovascular disease such as uncontrolled or symptomatic untreated arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Patient has clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification, left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO), unstable angina pectoris, symptomatic pericarditis, corrected QT Fridericia's formula (QTcF) > 480 msec on the screening electrocardiogram (ECG) (using the QTcF formula)
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class III or IV cardiac disease as defined by the New York Heart Association (NYHA) functional classification
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional classification
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 2 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association functional classification
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification, or congenital long QT syndrome, or QT interval corrected for heart rate, using Fridericia formula (QTcF) at Screening greater than (>) 470 milliseconds (ms)
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) > 480 msec.
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF < 40%
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF > 50%
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) ? 40%.
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (New York Heart Association > class 2), unstable angina, uncontrolled hypertension, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification would be exclusion for ibrutinib therapy but idelalisib would be an option
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
Clinically significant cardiovascular disease (eg, uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction =< 6 months prior to registration, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association functional classification
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening
Symptomatic cardiac disease, including congestive heart failure, coronary artery disease, and arrhythmias
Concurrent severe or uncontrolled medical disease (i.e., systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure).
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
Patients with a history of coronary artery disease may be included if they have had a normal cardiac stress test within 30 days of enrollment
Active coronary artery disease
Patients with a history of known coronary artery disease or a myocardial infarction within 12 months prior to pre-registration
Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years.
Symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), cerebrovascular event/stroke or myocardial infarction within the past 6 months
History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease or coronary artery disease).
New York Heart Association classification III or IV congestive heart failure, known symptomatic coronary artery disease, symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])
Known history of coronary artery disease, angina, myocardial infarction, congestive heart failure, cardiac arrhythmia or any other type of heart disease present within the last 6 months
No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than one year prior to entry, serious cardiac arrhythmias, or unstable angina; patients who are over 40 or have had previous cardiac disease will be required to have a negative or low probability cardiac stress test for cardiac ischemia
Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction (LVEF) < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate, to be eligible
The patient has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction < 40%, symptomatic coronary artery disease or symptomatic arrhythmias
Any other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease, that, in the opinion of the study investigator, would make the patient a poor candidate for the study
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or uncontrolled current cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])
Clinically significant cardiovascular abnormalities (e.g., congestive heart failure or symptoms of coronary artery disease), as determined by medical history and physical examination; patients with a history of cardiac disease must have a normal cardiac stress test (treadmill, echocardiogram, or myocardial perfusion scan) within the past 6 months of study entry
New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])
Has history of myocardial infarction having occurred less than 6 months before inclusion, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications; patients with coronary artery disease (CAD) recently treated with surgery and/or stent, if stable without symptomatic angina pectoris, active ischemia are eligible
Cardiac ejection fraction < 40% or symptomatic coronary artery disease or uncontrolled arrhythmia
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Significant cardiovascular abnormalities as defined by any one of the following: congestive heart failure, clinically significant hypotension, symptomatic coronary artery disease, or a documented ejection fraction of < 45%; any patient with an EF of 45-49% must receive clearance by a cardiologist to be eligible for the trial
EXCLUSION CRITERIA FOR TNBC: Significant cardiovascular abnormalities as defined by any one of the following: congestive heart failure, clinically significant hypotension, symptomatic coronary artery disease or a documented ejection fraction of < 45%; any patient with an EF of 45-49% must receive clearance by a cardiologist to be eligible for the trial
Patients who are greater than age 50, or who have a history of coronary artery disease, will be required to undergo cardiac stress testing within 6 months of screening and will be excluded if there is evidence of reversible ischemia
For patients designated to be treated on Group 2: cardiac ejection fraction >= 35%; for patients with significant risk factors for coronary artery disease (Framingham risk score > 15%), a cardiac stress test is recommended
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
Patients with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment
Active heart disease including symptomatic coronary artery disease, uncontrolled arrhythmias, or symptomatic congestive heart failure
Active cardiovascular disease including myocardial infarction (MI) < 6 months of screening, symptomatic coronary artery disease (CAD), arrhythmias, hypertension, or heart failure not controlled by medication.
History or signs of active coronary artery disease with angina pectoris within the last 6 months.
Symptomatic uncontrolled coronary artery disease or ejection fraction < 40%
Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease or heart block, or uncontrolled congestive heart failure
New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])
Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
Symptomatic coronary artery stenosis.
Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases; at the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled
Patients who have a history of congestive heart failure, coronary artery disease and myocardial infarction; active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention
Patients with a history of coronary artery disease with angina pectoris, or a history of congestive heart failure will not be eligible to receive DA-EPOCH-R chemotherapy
Cardiac-left ventricular ejection fraction < 40%, symptomatic coronary artery disease, or uncontrolled arrhythmias
Unstable hemodynamic status including: i. Documented myocardial infarction within six months of enrollment. ii.Symptomatic coronary artery stenosis. iii. Congestive heart disease requiring medication. iv. Anti-arrhythmic drug medication. v. Cardiac pacemaker. vi. Severe hypertension (diastolic BP > 100 on medication).
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Symptomatic cardiopulmonary disease (including congestive heart failure and hypertension), coronary artery disease, serious arrhythmia or chronic lung disease; patients with these conditions who are stable with relatively minor symptoms and who are appropriate candidates for surgical treatment of their tumor need not be excluded
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Symptomatic cardiopulmonary disease (including congestive heart failure and hypertension), coronary artery disease, serious arrhythmia or chronic lung disease; patients with these conditions who are stable with relatively minor symptoms and who are appropriate candidates for surgical treatment of their tumor need not be excluded
Significant cardiovascular abnormalities as defined by any one of the following: a. congestive heart failure, b. clinically significant hypotension, c. symptoms of coronary artery disease, d. presence of cardiac arrhythmias on electrocardiography (EKG) requiring drug therapy, e. ejection fraction < 50 % (echocardiogram or multigated acquisition scan [MUGA]).
Active including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction
Significant cardiovascular abnormalities including any one of the following: Congestive heart failure, Clinically significant hypotension, symptoms of coronary artery disease, presence of cardiac arrhythmias on electrocardiography (EKG) requiring drug therapy; or patients with a history of cardiovascular disease. (Patients with the above will undergo a cardiac evaluation which can include a stress test and/or echocardiography. Results of this evaluation will be considered before excluding patients on the basis of cardiovascular abnormalities). Subjects with evidence of stress-induced cardiac ischemia or ejection fraction less than 55% will be excluded.
A significant history or current evidence of cardiac disease including, but not limited to: congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrhythmias or myocardial infarction within the previous six months
Clinically significant cardiovascular abnormalities (e.g., congestive heart failure or symptoms of coronary artery disease), as determined by medical history and physical examination; patients with a history of cardiac disease must have a normal cardiac stress test (treadmill, echocardiogram, or myocardial perfusion scan) within the past 6 months of study entry
History of congestive heart failure and/or an left ventricular ejection fraction (LVEF) < 40%\r\n* Note: patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., > 65 years old [yo], diabetes, history of hypertension, elevated low-density lipoprotein [LDL], first degree relative with coronary artery disease) will undergo full cardiac evaluation and will not be eligible if they demonstrate significant irreversible ischemia on stress thallium or an ejection fraction < 40%
Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, uncontrolled arrhythmias, or symptomatic congestive heart failure
Symptomatic uncontrolled coronary artery disease or congestive heart failure
A stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion in those over 50 years of age or with a known history coronary artery disease
Subject has a history of peripheral artery disease (eg, claudication, Leo Buerger's disease).
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias; either an echocardiogram or multi-gated acquisition (MUGA) scan with an ejection fraction >= 45% must be obtained within 28 days prior to registration, or within 14 days prior to registration if the patient has received anthracycline in the 28 day window; (either method for measuring cardiac function is acceptable; however, the same scan must be used throughout treatment and follow-up to monitor the patient for cardiac toxicity); if the patient has symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration
Symptomatic cardiopulmonary disease (including congestive heart failure and hypertension), coronary artery disease, serious arrhythmia or chronic lung disease. Patients with these conditions who are stable with relatively minor symptoms and who are appropriate candidates for surgical treatment of their tumor need not be excluded
Active coronary artery disease.
Known significant or active coronary artery disease (CAD) or peripheral vascular disease (PVD) or cardiovascular disease (CVD) defined as abnormal stress test, symptoms, or requiring medication for the prevention of symptoms
Uncontrolled cardiac or coronary artery disease
New York Heart Association (NYHA) classification III or IV, known symptomatic coronary artery disease, or symptoms of coronory artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity (e.g. congestive heart failure, symptomatic coronary artery disease and/or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, or ongoing infection as manifested by fever
Significant cardiovascular abnormalities as defined by any one of the following:\r\n* Congestive heart failure\r\n* Clinically significant hypotension\r\n* Symptoms of coronary artery disease (angina, dyspnea)\r\n* Presence of cardiac arrhythmias on electrocardiogram (EKG) requiring drug therapy
Active coronary heart disease evidenced as angina or requiring medications to prevent angina
Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, arrhythmias not controlled with medication, or symptomatic congestive heart failure
Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (ejection fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy; patients with significant history of cardiac disease will be evaluated by the investigator or his designee
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
For patients with history of major coronary artery disease in the judgment of the responsible physician, a cardiac stress test (either exercise or pharmacologic) that demonstrates clinically significant abnormalities when performed within 4 weeks of first dose of study drug
For patients with history of anthracycline exposure or coronary artery disease co-management by cardiology to optimize cardioprotective medications will be required prior to Tosedostat initiation.
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
If the patient requires surgery of the bone metastasis, clinically serious comorbidities that render patient not medically fit for surgery (e.g. congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias and chronic lung disease not well controlled with medication; myocardial infarction within 12 months of enrollment)
Patients with cardiac insufficiency and a LVEF of < 40%; history of coronary artery disease or arrhythmia, which has required or requires ongoing treatment
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review
Unstable coronary artery disease or recent myocardial infarct (i.e. within 1 year).
Patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months
Patients with congestive heart failure with ejection fraction (EF) < 45% or uncontrolled cardiac disease (such as uncontrolled cardiac arrhythmia, uncontrolled coronary artery disease [CAD] with active symptoms due to CAD defined as unstable angina) are excluded from initiation of study treatment
Coronary artery disease with angina limiting exercise capability
Patients with clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months
History or evidence of cardiac disease: congestive heart failure; New York Heart Association class 2 or greater; active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization
Cardiac ejection fraction >= 40% (multigated acquisition [MUGA] or echocardiogram); for patients with significant risk factors for coronary artery disease (CAD) (including family history, hypertension, and/or dyslipidemia), or age > 50, stress echo or stress thallium testing is required
Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (ejection fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy; patients will be evaluated by the investigator or his designee
Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration
Recent history of myocardial infarction (MI) or symptomatic coronary artery disease within the preceding 6 months
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina
Major concomitant medical illness inclusive of severe chronic obstructive pulmonary disease, multiple sclerosis, symptomatic coronary artery disease, heart failure, recent major cerebrovascular accident, brittle diabetes, renal dialysis, end stage liver disease, labile hypertension, or any autoimmune disorder
History or signs of active coronary artery disease with or without angina pectoris within the last 6 months.
History or signs of active coronary artery disease with or without angina pectoris.
Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Cardiac stress test (e.g., stress thallium scan, stress echocardiography) with normal results if patient is suspected to have coronary artery disease.
History of active current coronary artery disease or unstable angina
Active heart disease including myocardial infarction (MI) within previous 3 months, symptomatic coronary artery disease (CAD), arrhythmias not controlled by medication, or uncontrolled CHF
Experienced clinically relevant coronary artery disease, myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, or symptomatic poorly controlled arrhythmia
The patient has a history of congestive heart failure, coronary artery disease or previous myocardial infarction.
No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months prior to study entry
Symptomatic coronary artery disease
Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary disease, and symptomatic heart failure.
Symptomatic or uncontrolled cardiac failure or coronary artery disease
Active coronary disease with a positive cardiac stress test
The presence of known ischemic heart disease as defined by significant obstructive heart disease (stenosis > 70%) seen on coronary angiography or cardiac computed tomography (CT)
Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
Any condition that would prevent the subject from performing the research procedures (e.g., unstable coronary artery disease)
History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal left ventricular (LV) function within 30 days of operation
History of coronary artery disease (angina or myocardial infarction)
Diabetes mellitus (insulin, oral, or both), chronic obstructive pulmonary disease, emphysema, reactive airway disease; chronic renal disease; multiple sclerosis; seizure disorder; murmurs; hepatitis; human immunodeficiency virus/acquired immunodeficiency syndrome; congestive heart failure; coronary artery disease; aortic aneurysm; history of coronary artery bypass graft; heart valve issues (prolapse, regurgitation, etc.); tachycardia; bradycardia; history of myocardial infarction
CONTROL (HEALTHY) GROUP: Healthy female without known coronary artery disease
CONTROL (HEALTHY) GROUP: Overt coronary artery disease or heart failure
Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization, arrhythmia requiring treatment such as atrial fibrillation, congestive heart failure, peripheral vascular disease, pulmonary embolism, or deep venous thrombosis.
Driver currently has (or has a history of) any cardiovascular disease (CVD) including coronary artery disease, angina or aortic stenosis; this does not include hypertension
Symptomatic uncontrolled coronary artery disease or congestive heart failure
Subject has coronary artery disease with an ischemic event within 6 months prior to enrollment.
History of coronary artery disease, including myocardial infarction, congestive heart failure (left ventricular [LV] ejection fraction < 50% or clinically significant diastolic dysfunction), or any serious medical condition which would preclude a patient from undergoing a bronchoscopy or would jeopardize the goals of the study
Subjects with life-threatening medical conditions that would preclude bronchoscopy, including: acute cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; or unstable coronary artery disease
Good general health with no history of diabetes, coronary artery disease, peripheral arterial disease, chronic disease or hypertension
Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease – congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication)
Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction < 45%, symptomatic coronary artery disease or symptomatic arrhythmias
Have a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis
Known to suffer from stable angina pectoris and/or proven coronary disease, or have symptoms suspicious of coronary disease
Patients with a history of coronary artery disease must have had a normal stress test within 180 days of starting IFN gamma
Symptomatic coronary artery disease currently or within the past 6 months,
The participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
The participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)\r\n* Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Concomitant diseases/conditions: Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
Clinically significant cardiovascular disease or peripheral vascular (e.g. myocardial infarction, unstable angina within 6 months of study entry), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia requiring medications, baseline corrected QT (QTc) > 450 msec or previous history of QT prolongation while taking other medications
Clinically significant cardiac disease, including: NYHA Class III or IV congestive heart failure, unstable angina, acute myocardial infarction within six months of planned first dose, arrhythmia requiring therapy (including torsades de pointes, with the exception of extrasystoles, minor conduction abnormalities, or controlled and well treated chronic atrial fibrillation)
Clinically significant cardiac diseases, including any of the following:\r\n* Unstable angina pectoris\r\n* Myocardial infarction =< 3 months prior to registration\r\n* Other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension
Cardiac issues consisting of either symptomatic congestive heart failure (NYHA Class II or higher), unstable angina pectoris, myocardial infarction within 6 months, and/or cardiac arrhythmia, including atrial fibrillation (which is symptomatic or requires treatment).
Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
Subject has clinically significant cardiac disease, including significant ischemic coronary disease, congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable arrhythmias, myocardial infarction or unstable angina within 6 months before randomization, a history of additional risk factors for torsades de pointes (eg, electrolyte abnormalities, family history of long QT syndrome), or a family history of sudden cardiac death before age 40
Severe, active co-morbidity defined as follows:\r\n* Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment\r\n* Known brain or central nervous system metastases or history of uncontrolled seizures\r\n* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association class III or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate)\r\n* Partial or complete gastrointestinal obstruction
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\r\n* New York Heart Association class III or IV cardiac disease, including pre-existing clinically significant arrhythmia, congestive heart failure, or cardiomyopathy\r\n* Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =< 1 year or serious concurrent infection
Any significant medical conditions, laboratory abnormality, or psychiatric illness that would exclude the subject from participation or interfere with study treatment, monitoring and compliance such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association [NYHA] III or IV), myocardial infarction ? 6 months prior to first study drug, clinically significant and uncontrolled cardiac arrhythmia (e.g. atrial fibrillation/flutter ventricular cardiovascular physiology is allowed), cerebrovascular accidents ? 6 months before study drug start\r\n* Severely impaired lung function
Impaired cardiac function, uncontrolled cardiac arrhythmia, or clinically significant cardiac disease including the following: a) New York Heart Association grade III or IV congestive heart failure, b) myocardial infarction within the last 6 months
History of unstable or deteriorating cardiac or pulmonary disease (other than BOS) within the previous 6 months, including but not limited to the following:\r\n* Unstable angina pectoris or myocardial infarction\r\n* Congestive heart failure requiring hospitalization\r\n* Uncontrolled clinically significant arrhythmias
Clinically significant cardiac disease defined by any of the following criteria: a.) New York Heart Association (NYHA) class IV heart failure b.) N-terminal prohormone of brain natriuretic peptide (NT-ProBNP) > 8500 ng/L c.) Symptomatic orthostatic hypotension with supine systolic blood pressure < 90 mm Hg d.) Unstable cardiac arrhythmia e.) Unstable angina f.) Myocardial infarction within the past 6 months
Severe, active co-morbidity defined as follows:\r\n* Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment (with the exception of uncomplicated urinary tract infection [UTI])\r\n* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from enrollment, New York Heart Association class Ill or IV congestive heart failure, and serious arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate)\r\n* Partial or complete gastrointestinal obstruction
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: \r\n*Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device.
Any significant diseases medical condition, laboratory abnormality, or psychiatric illness that would exclude the subject from participate or interfere with study treatment, monitoring and compliance such as:\r\n* Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association [NYHA] III or IV), myocardial infarction =< 6 months prior to first study drug, clinically significant and uncontrolled cardiac arrhythmia (e.g. atrial fibrillation/flutter ventricular cardiovascular physiology is allowed), cerebrovascular accidents =< 6 months before study drug start\r\n* Severely impaired lung function
History of clinically significant cardiovascular disease including, but not limited to:\r\n* Myocardial infarction or unstable angina =< 6 months prior to treatment initiation.\r\n* Clinically significant cardiac arrhythmia.\r\n* Deep vein thrombosis, pulmonary embolism, stroke =< 6 months prior to treatment initiation.\r\n* Congestive heart failure (New York Heart Association class III-IV).\r\n* Pericarditis/clinically significant pericardial effusion.\r\n* Myocarditis.\r\n* Endocarditis.
(Bevacizumab-related exclusion) Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents =< 6 months prior to study enrolment, myocardial infarction =< 6 months prior to study enrollment, unstable angina, grade II or greater congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: \r\n* a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device \r\n* b) No myocardial infarction within 3 months of registration
Patients with following cardiac conditions will be excluded:\r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration =< 6 months prior to enrollment\r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Patients with following cardiac conditions will be excluded:\r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\r\n* History of severe non-ischemic cardiomyopathy
Subject has clinically significant cardiac disease, including: myocardial infarction within 1 year before cycle 1, day 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association class III-IV); cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities; screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) > 470 msec
Impaired cardiac function, uncontrolled cardiac arrhythmia, or clinically significant cardiac disease including the following: a) New York Heart Association grade III or IV congestive heart failure, b) myocardial infarction within the last 6 months
Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (eg, prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram [ECG] changes) or uncorrected valvular disease and not primarily due to AL amyloid cardiomyopathy
Patients with clinically significant cardiac disease including one of the following currently or in the previous 6 months: myocardial infarction, unstable cardiac function due to unstable angina or congestive heart failure, congenital long QT syndrome, torsades de pointes or significant ventricular arrhythmias .
Evidence or history of significant cardiac disease (including evidence or history of significant cardiac disease (including myocardial infarction [MI] in the past 6 months, significant cardiac arrhythmia, stage III or IV congestive heart failure [CHF]); cardiac stress test will be done as clinically indicated; (the specific test to be chosen at the discretion of the principal investigator [PI])
Subject has clinically significant cardiac disease, including:\r\n* Myocardial infarction within 1 year before cycle 1 day 1, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association class III-IV)\r\n* Uncontrolled cardiac arrhythmia (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4 grade 2:2) or clinically significant electrocardiogram (ECG) abnormalities\r\n* Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) > 470 msec
History of cardiac disease, including: (a) myocardial infarction within 6 months of the start of study, (b) history of QTc prolongation or QTc >= 450 msec on screening EKG, history of additional risk factors for torsade de pointes (e.g., heart failure, hyperkalemia), and family history of long QT syndrome; (c) use of concomitant drugs that prolong QT/QTc interval; (d) New York Heart Association class III or IV heart disease, (e), active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically signification cardiac arrhythmia requiring therapy
Heart conditions - any of the following:\r\n* Any atrial fibrillation =< 3 months prior to registration\r\n* Unstable angina =< 12 months prior to registration\r\n* Prior symptomatic congestive heart failure\r\n* Documented myocardial infarction =< 6 months prior to registration (pretreatment electrocardiogram [ECG] evidence of infarct only will not exclude patients)\r\n* Prior significant ventricular arrhythmia requiring medication\r\n* Prior 2nd or 3rd degree heart block or other types of clinically significant conduction delay =< 6 months prior to registration\r\n* Clinically significant pericardial disease (including pericardial effusion, pericarditis) or cardiac valvular disease =< 12 months prior to registration\r\n* NOTE: As part of history and physical, all patients must be assessed for signs or symptoms of cardiac disease, or for prior history of cardiac disease; these conditions include but are not limited to diseases related to cardiac valves, pericardium, myocardium, atrioventricular delays or arrhythmias; it is strongly recommended that signs or symptoms of potentially clinically significant disease be evaluated with comprehensive cardiac echo
Active or unstable cardiac disease or heart attack within 3 months of starting study treatment
Cardiac syncope, uncompensated New York Heart Association (NYHA) class 3 or 4 congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, severe orthostatic hypotension, or clinically important autonomic disease
History of heart failure or cardiac arrhythmia
Any of the following cardiac conditions: \r\n* Clinically significant heart disease (New York Heart Association [NYHA] class III or IV) or symptomatic congestive heart failure \r\n* Myocardial infarction =< 6 months prior to enrollment \r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration \r\n* History of severe non-ischemic cardiomyopathy with ejection fraction =< 20%
Significant cardiac event (eg, myocardial infarction), New York Heart Association (NYHA) classification of heart disease >= 2 within 12 weeks before starting treatment, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
Known or suspected congestive heart failure, angina pectoris requiring antianginal medication, or other clinically significant cardiac condition
Patients must not have a history of myocardial infarction, severe or unstable angina, clinically significant peripheral vascular disease, grade 2 or greater heart failure, or serious and inadequately controlled cardiac arrhythmia
Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, must have a LVEF > 50% within 12 weeks prior to randomization.
Evidence of clinically significant cardiac disease at diagnosis, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac impairment due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
Congestive heart failure, clinically significant cardiac arrhythmia, history or current evidence of a myocardial infarction during the last 6 months, and/or a current electrocardiogram (ECG) tracing that is abnormal in the opinion of the treating Investigator, or unstable angina
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:\r\n* Active uncontrolled infection\r\n* Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device\r\n* No myocardial infarction within 3 months of registration
Adult patients (>= 18 years old) with the following cardiac conditions will be excluded: \r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure \r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of >= 2), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia\r\n* Known history of congenital QT prolongation or Torsade de pointes (TdP)\r\n* Complete left bundle branch or bifascicular block\r\n* QTc interval > 450 ms for men or > 470 ms for women\r\n* Persistent or history of clinically meaningful ventricular arrhythmias or atrial fibrillation\r\n* Unstable pectoris or myocardial infarction =< 3 months prior to starting study treatment\r\n* Uncontrolled hypertension (blood pressure >= 160/95 mmHg)\r\n* Other clinically significant heart disease such as congestive heart failure requiring treatment
History of relevant coronary heart disease or myocardial infarction within last 3 years, NYHA Grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or serious cardiac arrhythmia requiring medication except atrial fibrillation.
Significant associated diseases including documented human immunodeficiency virus (HIV) infection, uncontrolled hypertension (diastolic blood pressures > 95%ile for age), unstable angina, congestive heart failure (> New York [NY] class II), poorly controlled diabetes (hemoglobin A1c [Hgb A1c] > 7%), coronary angioplasty within 6 months, myocardial infarction within the last 6 months, or uncontrolled atrial or ventricular cardiac arrhythmia, abnormal coagulation, persistent abnormal urinalysis reflecting intrinsic renal disease
Unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia, or need for antiarrhythmic medication for which inability to take an oral preparation of regular medication for 48 hours would represent an unacceptable risk
Patients with following cardiac conditions will be excluded: \r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Significant cardiac disease (i.e. uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous year) or serious cardiac arrhythmia requiring medication.
Cardiac disease (NYHA classes II-IV) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment.
RENAL & BLADDER: History of clinically significant cardiovascular disease including, but not limited to:\r\n* Myocardial infarction or unstable angina ? 6 months prior to treatment initiation \r\n* Clinically significant cardiac arrhythmia\r\n* Deep vein thrombosis, pulmonary embolism, stroke ? 6 months prior to treatment initiation\r\n* Congestive heart failure (New York Heart Association class III-IV)\r\n* Pericarditis/clinically significant pericardial effusion\r\n* Myocarditis\r\n* Endocarditis
Subject has clinically significant cardiac disease, including: 1) myocardial infarction within 1 year before study enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association class III-IV); 2) uncontrolled cardiac arrhythmia or clinically significant electrocardiography (ECG) abnormalities; 3) screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) > 470 msec
Other medical conditions including but not limited to:\r\n* History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C\r\n* Active infection requiring parenteral antibiotics\r\n* New York Heart Association class II-IV congestive heart failure (serious cardiac arrhythmia requiring medication)\r\n* Myocardial infarction or unstable angina =< 6 months prior to registration\r\n* Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\r\n* Clinically significant peripheral vascular disease\r\n* History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.), clinically significant stroke or transient ischemic attack (TIA) =< 6 months prior to registration, seizures not controlled with standard medical therapy\r\n* Neuropathy ? grade 3
Subjects with clinically significant active ischemic heart disease, cardiac muscle disease (including cardiomyopathy or congestive heart failure) or myodegenerative disorders that may affect safe study participation
Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to, patients with congestive heart failure (New York Heart Association [NYHA] class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring > 2 medications for adequate control; diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive pulmonary disease (COPD) requiring > 2 hospitalizations in the preceding 12 months
Unstable cardiovascular disease (eg, uncontrolled hypertension, peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute coronary syndrome) within 6 months of starting study treatment
Other medical conditions including but not limited to:\r\n* History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C\r\n* Active infection requiring parenteral antibiotics\r\n* Immuno-compromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\r\n* New York Heart Association class II-IV congestive heart failure (serious cardiac arrhythmia requiring medication)\r\n* Myocardial infarction or unstable angina =< 6 months prior to registration\r\n* Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\r\n* Clinically significant peripheral vascular disease\r\n* History of central nervous system (CNS) disease (e.g., primary brain tumor, vascular abnormalities, etc.), clinically significant stroke or transient ischemic attack (TIA) =< 6 months prior to registration, seizures not controlled with standard medical therapy\r\n* History of hypertensive crisis or hypertensive encephalopathy\r\n* Therapeutic anticoagulation requiring international normalized ratio (INR) > 2.0
Significant cardiac event (e.g., myocardial infarction), superior vena cava syndrome, New York Heart Association (NYHA) classification of heart disease >= 2 within 12 weeks, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia
Patients must not have serious intercurrent illness such as infection requiring intravenous (IV) antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Clinically significant cardiac disease, including:\r\n* >= Grade 2 myocardial infarction within 6 months prior to day 1 of protocol therapy\r\n* Unstable or uncontrolled disease condition relating to or affecting cardiac function (e.g. unstable angina, congestive heart failure, New York Heart Association Class III-IV) within 6 months prior to day 1 of protocol therapy\r\n* >= Grade 2 uncontrolled cardiac arrhythmia
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Patients with a history of cardiac disease including: (1) uncontrolled angina, congestive heart failure, or myocardial infarction within six months prior to study entry, (2) congenital long QT syndrome, (3) clinical significant ventricular arrhythmias
Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction\n             within 3 months of start of study treatment, serious uncontrolled cardiac arrhythmia\n             or any other clinically significant heart disease.
Patients with recent (? 6 months) cardiac angina, difficult to control congestive\n             heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias\n             will be excluded
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia\r\n* Patients with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drug should have an electrocardiogram (EKG) and echocardiogram performed to evaluate cardiac function as clinically indicated\r\n* Patients with evidence of congestive heart failure (CHF), myocardial infarction (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab tests and cardiology consultations as clinically indicated including EKG, creatine phosphokinase (CPK), troponin, and echocardiogram
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with clinically significant cardiovascular disease; this includes: \r\n* Patients with significant cardiac conduction abnormalities, i.e. PR interval > 0.24 seconds (sec) or 2nd or 3rd degree atrioventricular (AV) block\r\n* Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg\r\n* Myocardial infarction, cardiac arrhythmia or unstable angina < 6 months prior to registration\r\n* New York Heart Association (NYHA) grade II or greater congestive heart failure\r\n* Serious cardiac arrhythmia requiring medication\r\n* Grade II or greater peripheral vascular disease (exception: episodes of ischemia < 24 hours [hrs] in duration, that are managed non-surgically and without permanent deficit)\r\n* History of cerebrovascular attack (CVA) within six months
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: \r\n* Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device\r\n* No myocardial infarction within 3 months of registration
Medically documented cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, or severe orthostatic hypotension or clinically important autonomic disease.
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, and congestive heart failure related to primary cardiac disease, a history of a serious uncontrollable arrhythmia despite treatment, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
Significant cardiovascular disease, including: Active clinically symptomatic left ventricular failure,uncontrolled hypertension, myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug, history of serious ventricular arrhythmia, cardiac arrhythmias requiring anti-arrhythmic medications.
Clinically significant cardiac disease defined by CHF New York Heart Association (NYHA) Class > 1; uncontrolled clinically significant arrhythmia in last 6 months; Acute Coronary Syndrome (ACS) (angina or MI) in last 6 months.
Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled hypertension or history of cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial, significant GI bleed within 30 days, metastatic brain disease, renal failure requiring dialysis
Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., subjects with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), symptomatic pulmonary embolism within 3 months, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia as determined by the treating physician.
Currently active, clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease within 6 months of screening
Medically documented cardiac syncope, uncompensated congestive heart failure, myocardial infarction within the previous 6 months, unstable angina pectoris, clinically significant repetitive atrial or ventricular arrhythmias despite antiarrhythmic treatment, or severe orthostatic hypotension or clinically significant uncompensated autonomic insufficiency
Patients with any of the following conditions or complications are NOT eligible for participation:\r\n* Gastrointestinal (GI) tract disease resulting in an inability to take oral medication\r\n* Malabsorption syndrome\r\n* Require IV alimentation\r\n* History of prior surgical procedures affecting absorption\r\n* Uncontrolled inflammatory GI disease (e.g., Crohn’s, ulcerative colitis)\r\n* Hypersensitivity of any of the components of eribulin or lenvatinib\r\n* History of significant neurological (no neuropathy more than grade 2) or psychiatric disorders\r\n* Significant non neoplastic liver disease (cirrhosis, active chronic hepatitis)\r\n* Immunocompromised subjects, including patients with human immunodeficiency virus\r\n* Significant non neoplastic renal disease\r\n* Active infection requiring systemic therapy\r\n* Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment\r\n* Prolongation of corrected QT interval (QTc) to more than 480 milliseconds when electrolyte balance is normal\r\n* Major surgery within 4 weeks prior to first dose of the study drug
Patients who have any severe and/or uncontrolled cardiac disease within =< 6 months prior to start of everolimus, including: unstable angina pectoris, symptomatic congestive heart failure of New York Heart Association class III or IV, myocardial infarction, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
Known history of ischemic cardiac disease (including angina requiring anti-anginal medications, myocardial infarction, coronary artery disease documented on cardiac catheterization or ischemia documented on stress test), congestive heart failure, clinically significant arrhythmia or conduction system abnormalities, clinically significant valvular disease, clinically significant pericardial effusion or EF below the lower limit of normal
History of any significant cardiac event (e.g. myocardial infarction), superior vena cava syndrome, New York Heart Association (NYHA) classification of heart disease >= 2 within 12 weeks before starting treatment, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy
Myocardial infarction having occurred less than 6 months before inclusion, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications
Clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker
Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
Significant or uncontrolled congestive heart failure (CHF), myocardial infarction, significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.
Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system (e.g. active infection, clinically relevant impairment of cardiac function, severe heart failure/cardiac insufficiency, unstable angina pectoris or history of recent myocardial infarction), which in the opinion of the investigator precludes treatment with LDAC.
Clinically significant cardiovascular disease or cardiac insufficiency,cardiomyopathy, preexisting clinically significant arrhythmia, acute myocardial infarction within 3 months of enrolment, angina pectoris within 3 months of enrolment.
History of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including but not limited to congestive heart failure (NYHA Class 3 or 4), unstable angina; cardiac arrhythmia, recent (within past 6 months) myocardial infarction or stroke; uncontrolled hypertension; diabetes mellitus with >2 episodes of ketoacidosis in the preceding 12 months, COPD requiring >2 hospitalizations in preceding 12 months
Patients with known overt cardiac disease, including but not limited to a history of myocardial infarction, severe or unstable angina, clinically significant peripheral vascular disease, grade 2 or greater heart failure, or serious and inadequately controlled cardiac arrhythmia are not eligible
Patients with following cardiac conditions will be excluded:\r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Clinically significant cardiac disease (including symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia) within 1 year of study enrollment
Patients must not have significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Patients with following cardiac conditions will be excluded: \r\n* New York Heart Association (NYHA) stage III or IV congestive heart failure \r\n* Myocardial infarction =< 6 months prior to enrollment \r\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration \r\n* History of severe non-ischemic cardiomyopathy with ejection fraction (EF) =< 20%
Any of the following concurrent medical conditions or history: \t   \r\n* Uncontrolled hypertension, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) class 2 or greater, clinically significant peripheral vascular disease, serious cardiac arrhythmia requiring medication\r\n* History of myocardial infarction (MI) or stroke within 6 months before enrollment\r\n* History of intra-abdominal abscess within 4 weeks before enrollment, abdominal fistula, gastrointestinal perforation, or active peptic ulcer disease\r\n* Evidence of bleeding diathesis or coagulopathy\r\n* Serious non-healing wound, ulcer or bone fracture
Myocardial infarction in the previous 12 weeks. Active ischemia or any other uncontrolled cardiac condition such as angina pectoris, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or CHF.
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =< 6 months prior to enrollment
Patient has had clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =< 1 year before randomization
Patients must not have clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) =< 1 year before randomization
History of documented congestive heart failure, angina pectoris requiring medication, electrocardiogram (ECG) evidence of transmural myocardial infraction, poorly controlled hypertension, clinically significant valvular heart disease, or high-risk uncontrollable arrhythmias
No clinically significant history of cardiac disease, (i.e. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication)
Cardiac related illnesses including, but not limited to:\r\n* Symptomatic congestive heart failure including participants with grade III/IV cardiac disease as defined by the New York Heart Association functional criteria\r\n* Unstable angina pectoris\r\n* Cardiac arrhythmia
Heart failure or significant heart disease including significant arrhythmias, myocardial infarction within the last 3 months, unstable angina, documented ejection fraction < 30%, or current digoxin therapy
Clinically significant (i.e., active) cardiovascular disease, uncontrolled hypertension, unstable angina, history of myocardial infarction, cardiac failure class II-IV
Patient has in the opinion of the investigator any intercurrent conditions that could preclude their participation in the study, pose an undue medical hazard, or that could interfere with the interpretation of the study results, including, but not limited to, patients with congestive heart failure (NYHA Class III or IV; refer to Appendix III), unstable angina, cardiac arrhythmia requiring treatment, recent (within the prior 6 months) myocardial infarction, acute coronary syndrome or stroke, severe obstructive pulmonary disease, hypertension requiring more than2 medications for adequate control, or diabetes mellitus with more than 2 episodes of ketoacidosis in the prior 12 months.
History of significant cardiac disease. Includes second/third degree heart block; significant ischemic heart disease; mean QTc interval > 480 msec prior to study start; poorly controlled hypertension; congestive heart failure of NYHA Class II or worse
Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, any condition requiring anti-arrhythmic therapy, ischemic or valvular heart disease, or a myocardial infarction within the past 6 months
History of heart failure or serious cardiac arrhythmia
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to first study treatment, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities.*
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months of study entry, uncontrolled congestive heart failure, and uncontrolled arrhythmia. Subjects with congestive heart disease or arrhythmia such as atrial fibrillation whose cardiac disease is well controlled on a stable medical regimen are eligible.
Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome [SVC], New York Heart Association [NYHA] classification of heart disease >= 2 within 3 months before entry); or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia
Clinically significant cardiac disease as judged by the investigator including unstable angina, acute myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, and uncontrolled arrhythmia. Subjects with congestive heart disease or arrhythmias such as atrial fibrillation whose cardiac disease is well controlled on a stable medical regimen are eligible.
c. Significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergency room visit within last 3 months
History of clinically significant cardiovascular disease including, but not limited to: \r\n* Myocardial infarction or unstable angina =< 6 months prior to treatment initiation \r\n* Clinically significant cardiac arrhythmia \r\n* Deep vein thrombosis, pulmonary embolism, stroke =< 6 months prior to treatment initiation \r\n* Congestive heart failure (New York Heart Association class III-IV) \r\n* Pericarditis/clinically significant pericardial effusion \r\n* Myocarditis \r\n* Endocarditis
Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
No history of serious cardiac disease that is not adequately controlled; patients with documented myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina, clinically significant pericardial effusion or arrhythmia are ineligible; an electrocardiogram (ECG) must be done within 4 weeks prior to study entry on all patients
Any significant cardiac event(s) within the 12 months prior to registration, such as episode(s) of symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris or persistent, stable angina pectoris, or cardiac arrhythmia requiring medication
Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome [SVC], New York Heart Association [NYHA] classification of heart disease >= 2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ?6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
History of congestive cardiac failure or an electrocardiography (EKG) suggesting significant conduction defect, or myocardial ischemia, or active psychiatric disease requiring treatment that would interfere with the understanding or conduct of the study
Patient has any of the following cardiac abnormalities (as determined by treating Doctor of Medicine [MD]):\r\n* Symptomatic congestive heart failure\r\n* Myocardial infarction =< 6 months prior to enrollment\r\n* Unstable angina pectoris\r\n* Serious uncontrolled cardiac arrhythmia\r\n* Corrected QT interval (QTc) >= 480 msec (>= 500 msec in the presence of right bundle branch block [RBBB])
Patients must not have active significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
Current evidence of cardiac ischemia
Grade 2 or higher peripheral ischemia [brief (< 24 hours) episode of ischemia managed non-surgically and without permanent deficit].
Symptomatic peripheral ischemia.
Presence of known or suspected ongoing ischemia of non-tumor tissues including
Cardiac stress test within past 6 months without evidence of reversible ischemia
Evidence of ischemia or myocardial infarction within the past 6 months, or any significant abnormality on ECG.
Electrocardiogram without evidence of acute cardiac ischemia
Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior to study registration
symptomatic ischemia
Symptomatic ischemia, or
Current signs or symptoms of heart failure (HF) or ischemia
Electrocardiography (EKG) without evidence of ischemia or significant arrhythmia
Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.
Symptomatic peripheral ischemia
Electrocardiography (ECG) without evidence of clinically significant arrhythmia or ischemia.
CTEP CTCAE version 4.0, grade 2 or higher peripheral ischemia (brief [< 24 hours (hrs)] episode of ischemia managed non-surgically and without permanent deficit)
Symptomatic ischemia or myocardial infarction within the previous 6 mo
ECG without evidence of clinically significant arrhythmia or ischemia.
ECG without evidence of clinically significant arrhythmia or ischemia
History of cerebrovascular or myocardial ischemia within 6 months of initiation
Symptomatic peripheral ischemia.
No active ischemia by electrocardiography (ECG) or clinical symptoms
Grade 2 or higher peripheral ischemia, except for brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit.
ECG evidence of acute ischemia or active conduction system abnormalities with the exception of any of the following:
Myocardial infarction within the past 6 months, unstable and/or symptomatic arrhythmia, or evidence of ischemia on ECG.
Participants with a recent history (< 6 months) of a major infarct including but not inclusive to bowel ischemia, cerebral vascular accident, transient ischemic attack, myocardial infarction, limb ischemia, or skin necrosis
Patients with myocardial ischemia or peripheral muscle ischemia
All patients must have a stress test within 6 months of starting treatment showing no evidence of cardiac ischemia
Patients with myocardial ischemia or peripheral muscle ischemia
Patients with myocardial ischemia or peripheral muscle ischemia
History of significant tachyarrhythmia, severe angina, or myocardial ischemia
Symptomatic ischemia, or
Patients with myocardial ischemia or peripheral muscle ischemia
History of serious organ dysfunction or disease involving the heart (left ventricular ejection fraction < 50%; unstable angina, acute myocardial infarction within 6 months prior to randomization, congestive heart failure New York Heart Association [NYHA] III-IV, and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities)
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia, or myocardial infarction within 6 months prior to randomization
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator; myocardial infarction within 6 months prior to registration
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of >= 3, unstable angina or poorly controlled arrhythmia as determined by the investigator; myocardial infarction within 6 months
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator; myocardial infarction within 6 months prior to enrollment
Patients with clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to enrollment, congestive heart failure (New York Heart Association [NYHA ] III-IV), and arrhythmia unless controlled by therapy (with the exception of extra systoles or minor conduction abnormalities), are NOT eligible
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia; myocardial infarction within 6 months prior to enrollment
Patients must not have a history of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia or myocardial infarction within 6 months prior to registration; if clinically indicated, echocardiogram or multigated acquisition (MUGA) must be performed and cardiac ejection fraction must be >= 50%
Patients with cardiovascular disease including congestive heart failure grade III or IV according to the New York Heart Association (NYHA) classification, left ventricular ejection fraction of < 50%, myocardial infarction within previous 6 months or poorly controlled hypertension
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, New York Heart Association (NYHA) functional classification of 3, unstable angina or poorly controlled arrhythmia; myocardial infarction within 6 month prior to the study entry
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (New York Heart Association [NYHA] III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia; myocardial infarction within 6 months prior to study entry
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (New York Heart Association [NYHA] III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities
Uncontrolled, current significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (New York Heart Association [NYHA] III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities\r\n* Patients with history of cardiac disease, such as coronary disease, arrhythmia or congestive heart failure that are on appropriate medical therapy and without evidence of current decompensation are eligible
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (New York Heart Association [NYHA] III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (New York Heart Association [NYHA] III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (New York Heart Association [NYHA] III-IV), and arrhythmia unless controlled by therapy, with the exception of extrasystoles or minor conduction abnormalities
History of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia, or myocardial infarction within 6 months
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia; myocardial infarction within 6 months prior to randomization
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia, myocardial infarction within 6 months prior to study entry