[c09aa8]: / clusters / 9knumclustersv2 / clust_1648.txt

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Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within months of registration
Significant history of uncontrolled cardiac disease defined as uncontrolled arrhythmias, unstable angina, myocardial infarction within the last months, and uncontrolled congestive heart failure or any class - New York Heart Association classification cardiac disease
Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within months of registration (New York Heart Association [NYHA] classification III-IV)
Unstable angina, congestive heart failure [NYHA (New York Heart Association) >class II], uncontrolled hypertension [diastolic > mmHg], uncontrolled cardiac arrhythmia, or recent (within year) myocardial infarction, uncontrolled diabetes mellitus
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to: History of immune deficiencies or autoimmune disease; Myocardial infarction or arterial thromboembolic events within months prior to screening or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > msec; Uncontrolled hypertension or diabetes mellitus; Another known malignancy that is progressing or requires active treatment; Active infection requiring systemic therapy; Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
The patient has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class or congestive heart failure [Appendix ], uncontrolled angina, history of myocardial infarction, unstable angina or stroke within months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
Heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, ongoing cardiac arrhythmia requiring medication (Grade ?, by NCI CTCAE v. .), or significant/unstable concurrent medical illness by investigator opinion
Subjects with significant or uncontrolled cardiovascular disease (e.g., uncontrolled hypertension, peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute coronary syndrome) within months prior to starting study treatment or heart attack within months prior to starting study treatment
Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:\r\n* New York Heart Association heart failure > class \r\n* Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, myocardial infarction within the last months, uncontrolled arrhythmias, unstable angina, non-compensative congestive heart failure, or clinically significant pericardial effusion)
Participants must not have had uncontrolled or significant cardiovascular disease including, but not limited to, any of the following: \r\n* Myocardial infarction or stroke/transient ischemic attack within the past months\r\n* Uncontrolled angina within the past months\r\n* Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\r\n* History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III to IV, pericarditis, significant pericardial effusion, or myocarditis)\r\n* Cardiovascular disease-related requirement for daily supplemental oxygen therapy
Active and uncontrolled comorbidities including active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, clinically significant and uncontrolled arrhythmia as judged by the treating physician
Patients with uncontrolled or significant cardiovascular disease including, but not limited to, any of the following are ineligible:\r\n* Myocardial infarction or stroke/transient ischemic attack (TIA) within the months prior to consent\r\n* Uncontrolled angina within the months prior to consent\r\n* Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\r\n* History of other clinically significant cardiovascular disease (i.e., cardiomyopathy, congestive heart failure with New York Heart Association [NYHA] functional classification III-IV, myocarditis and pericarditis, significant pericardial effusion, significant coronary stent occlusion, deep venous thrombosis, etc.)\r\n* Cardiovascular disease-related requirement for daily supplemental oxygen
Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association (NYHA) class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B, C or HIV, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
History of clinically significant cardiac dysfunction, including the following:\r\n* Current unstable angina\r\n* Current symptomatic congestive heart failure of New York Heart Association (NYHA) class or higher.\r\n* Uncontrolled hypertension >= grade (patients with a history hypertension controlled with anti-hypertensives to =< grade are eligible).\r\n* Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below %, whichever is lower.\r\n* Uncontrolled arrhythmias.\r\n* Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack within the previous months.
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:\r\n* Patients on life support or in a critical care unit\r\n* Patients with unstable occlusive disease (e.g., crescendo angina)\r\n* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia\r\n* Patients with uncontrolled congestive heart failure (New York heart Association [NYHA] class IV)
Clinically-significant cardiac disease:\r\n* Recent myocardial infarction (=< months prior to day )\r\n* Unstable angina pectoris\r\n* Uncontrolled congestive heart failure (New York Heart Association > class II)\r\n* Uncontrolled hypertension (>= Common Terminology Criteria for Adverse Events [CTCAE] version [v]. grade )\r\n* Prior history of hypertensive crisis or hypertensive encephalopathy\r\n* Uncontrolled cardiac arrhythmias\r\n* Clinically-significant vascular disease (e.g. aortic aneurysm, or dissecting aneurysm)\r\n* Severe aortic stenosis\r\n* Clinically significant peripheral vascular disease\r\n* >= Grade cardiac toxicity following prior chemotherapy\r\n* Corrected QT interval (QTc) > for females and > for males
New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality (eg, QTcF > msec)
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than that related to the primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, myocardial infarction within the last months, unstable arrhythmias, unstable angina, or clinically significant pericardial effusion)
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, myocardial infarction within the last months, unstable arrhythmias, unstable angina, or clinically significant pericardial effusion)
Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality (eg, QTcF > msec)
Cardiac:\r\n* History of clinically significant cardiac dysfunction, including the following:\r\n** Current unstable angina\r\n** Current symptomatic congestive heart failure of New York Heart Association (NYHA) class or higher\r\n** History of congenital long QT syndrome or mean corrected QT Fridericias formula (QTcF) > msec at baseline or uncorrectable electrolyte abnormalities\r\n** Uncontrolled hypertension >= grade (patients with a history of hypertension controlled with anti-hypertensives to =< grade and patients with hypertension grade that have treating physician approval of safety, are eligible)\r\n** Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below %, whichever is lower\r\n** Uncontrolled arrhythmias\r\n** Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack within the previous months \r\nNote: Optional tumor biopsies (punch, fine-needle aspiration [FNA], core or excisional) at pre-treatment, week , and at progression will be presented to subjects considering this study; additional optional tumor biopsies may also be offered if deemed appropriate by principal investigator; additional subjects at the MTD/RPD expansion cohort are required to have correlative studies (blood collection and tumor biopsies at the defined time points)
Significant cardiac disease as determined by the investigator including:\r\n* Known or suspected cardiac amyloidosis\r\n* Congestive heart failure of class III or IV of the New York Heart Association (NYHA) classification\r\n* Uncontrolled angina, hypertension or arrhythmia\r\n* Myocardial infarction in the past months\r\n* Any uncontrolled or severe cardiovascular disease
History of clinically significant cardiac dysfunction, unless deemed to be direct result of disease, including the following:\r\n* Current unstable angina\r\n* Symptomatic congestive heart failure of New York Heart Association (NYHA) class or higher\r\n* Uncontrolled hypertension > grade (patients with history of hypertension controlled with anti-hypertensives to =< grade are eligible\r\n* Left ventricular ejection fraction (LVEF) below institutional lower limit of normal or below %\r\n* Uncontrolled arrhythmias\r\n* Myocardial infraction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack within the previous months
Subjects must have evidence of adequate cardiac function, as defined by the following: absence of New York Heart Association (NYHA) class II, III, or IV congestive heart failure; absence of uncontrolled angina or hypertension; absence of myocardial infarction in the previous months; absence of clinically significant bradycardia, or other uncontrolled cardiac arrhythmia defined as grade or according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version .
Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association [NYHA] class III or IV, myocardial infarction within months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association [NYHA] class III or IV, myocardial infarction within months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association [NYHA] grade ? ), uncontrolled hypertension or clinically significant arrhythmia currently requiring medical treatment
Significant associated diseases including documented human immunodeficiency virus (HIV) infection, uncontrolled hypertension (diastolic blood pressures > %ile for age), unstable angina, congestive heart failure (> New York [NY] class II), poorly controlled diabetes (hemoglobin Ac [Hgb Ac] > %), coronary angioplasty within months, myocardial infarction within the last months, or uncontrolled atrial or ventricular cardiac arrhythmia, abnormal coagulation, persistent abnormal urinalysis reflecting intrinsic renal disease
Has uncontrolled clinically significant cardiac disease, including myocardial infarction within months before date of study entry or unstable or uncontrolled angina, congestive heart failure, New York Heart Association (NYHA) Class III-IV, uncontrolled cardiac arrhythmia (Grade or higher).
Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association (NYHA) class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B, hepatitis C or HIV, or other significant co-morbid conditions that, in the opinion of the Investigator, would impair study participation or cooperation.
Severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (? Grade , according to NCI CTCAE v.) or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
History of cardiac disease: congestive heart failure>NYHA Class or uncontrolled hypertension
Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac arrhythmia requiring medication (?grade , according to NCI CTCAE v.), myocardial infarction within months prior to starting study treatment, or any other significant or unstable concurrent medical illness that in the opinion of the investigator would preclude protocol therapy.
Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:\r\n* Myocardial infarction or stroke/transient ischemic attack within the past months\r\n* Uncontrolled angina within the past months\r\n* Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)\r\n* QT interval corrected for heart rate using Fridericias formula (QTcF) prolongation > msec\r\n* History of other clinically significant heart disease (e.g. cardiomyopathy, congestive heart failure with New York Heart Association [NYHA] functional classification III-IV, pericarditis, significant pericardial effusion, or myocarditis)
Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, psychiatric illness that would limit compliance with study requirements, or active heart disease including confirmed myocardial infarction within previous months, symptomatic coronary artery disease, clinically significant arrhythmias not controlled by medication, or uncontrolled congestive heart failure New York (NY) Heart Association class III or IV
Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association [NYHA] class or , congestive heart failure, uncontrolled or unstable angina, history of myocardial infarction or stroke within months prior to study entry, or clinically significant arrhythmias not controlled by medication)
Clinically significant cardiac disease, including:\r\n* >= Grade myocardial infarction within months prior to day 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 months prior to day of protocol therapy\r\n* >= Grade uncontrolled cardiac arrhythmia
Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within months of registration
Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within months of registration (New York Heart Association [NYHA] classification III-IV)
The patient has clinically significant cardiovascular disease (e.g., uncontrolled or any NYHA Class or congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
Clinically significant cardiac disease defined by CHF New York Heart Association (NYHA) Class > ; uncontrolled clinically significant arrhythmia in last months; Acute Coronary Syndrome (ACS) (angina or MI) in last months.
Uncontrolled heart disease
Subject has history (within previous years) of clinically significant pulmonary hypertension, uncontrolled systemic hypertension, hypertensive crisis, congestive heart failure, myocardial infarction, aneurysm or aneurysm repair or the left ventricular ejection fraction (LVEF) less than or equal to %.
Patients must not have clinically significant illness including uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past months, uncontrolled >= grade cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus; patients must have undergone an electrocardiogram (EKG) within days prior to registration
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 , myocardial infarct within months, prolonged QT/QTc >ms, 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 days, metastatic brain disease, renal failure requiring dialysis
Participant has any of the following conditions: Non-secretory or oligo-secretory multiple myeloma, active plasma cell leukemia i.e., either % of peripheral white blood cells or greater than . X ^/liter (L) circulating plasma cells by standard differential, waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), known Human Immunodeficiency Viral (HIV) infection, active hepatitis B or C infection based on blood screen tests, significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within months of randomization, or congestive heart failure New York Heart Association (NYHA) Class greater than or equal to , Major surgery within weeks prior to randomization, acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within days prior to randomization, peripheral neuropathy greater than or equal to Grade or greater than or equal to Grade with pain within weeks prior to randomization, uncontrolled diabetes or uncontrolled hypertension within days prior to randomization, any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the investigator, such as but not limited to:\r\n* Myocardial infarction or arterial thromboembolic events within months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease, or a QTCB (corrected according to Bazett's formula) interval > msec; serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA; uncontrolled hypertension (systolic > and/or diastolic > mm Hg)\r\n* Acute and chronic active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy\r\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
Clinically significant cardiovascular disease (e.g., uncontrolled or any NYHA Class or CHF, uncontrolled angina, history of MI, unstable angina or stroke within months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ?), uncontrolled hypertension or clinically significant arrhythmia currently requiring medical treatment
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., Crohns, 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 ) 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 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 milliseconds when electrolyte balance is normal\r\n* Major surgery within weeks prior to first dose of the study drug
Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association class [NYHA] class III or IV, myocardial infarction within months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
Known significant cardiac abnormalities including:\r\n* Congestive heart failure, New York Heart Association (NYHA) class III or IV\r\n* Uncontrolled angina, arrhythmia or hypertension\r\n* Myocardial infarction within the past six months\r\n* Any other uncontrolled or severe cardiovascular condition\r\n* Prior cerebrovascular event with residual neurologic deficit
Significant cardiac disease as determined by the investigator including:\r\n* Known or suspected cardiac amyloidosis\r\n* Congestive heart failure of class III or IV of the New York Heart Association (NYHA) classification\r\n* Uncontrolled angina, hypertension or arrhythmia\r\n* Myocardial infarction in past months\r\n* Any uncontrolled or severe cardiovascular disease\r\n* Prior cerebrovascular event with persistent neurologic deficit
New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as active angina pectoris, clinically significant cardiac arrhythmia that requires therapy in the opinion of the treating physician or PI, uncontrolled hypertension (blood pressure > systolic and > diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus in the opinion of the treating physician or PI, or uncontrolled congestive heart failure in the opinion of the treating physician or PI
Other clinically significant heart disease (e.g. uncontrolled congestive heart failure or uncontrolled hypertension)
Severe, concurrent illness including congestive heart failure, significant cardiac disease and uncontrolled hypertension, that would likely prevent the patient from being able to comply with the study protocol
Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension)
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 or greater, clinically significant peripheral vascular disease, serious cardiac arrhythmia requiring medication\r\n* History of myocardial infarction (MI) or stroke within months before enrollment\r\n* History of intra-abdominal abscess within 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
Significant cardiac disease including myocardial infarction or unstable angina within months, uncontrolled hypertension despite medical therapy (defined as blood pressure > / in spite of adequate medical therapy), active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, stroke within preceding months
Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant pulmonary disease other than primary cancer, uncontrolled diabetes mellitus, and/or significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last months, unstable arrhythmias, unstable angina, or clinically significant pericardial effusion)
New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >= systolic and >= diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus, or congestive heart failure
Clinically-significant cardiac disease including:\r\n* Recent myocardial infarction (=< months prior to first dose of mirvetuximab soravtansine)\r\n* Unstable angina pectoris\r\n* Uncontrolled congestive heart failure (New York Heart Association > class II)\r\n* Uncontrolled hypertension (>= Common Terminology Criteria for Adverse Events [CTCAE] version [v]. grade ), prior history of hypertensive crisis or hypertensive encephalopathy\r\n* Uncontrolled cardiac arrhythmias\r\n* Clinically-significant vascular disease (e.g. aortic aneurysm, or dissecting aneurysm)\r\n* Severe aortic stenosis\r\n* Clinically significant peripheral vascular disease\r\n* Cardiac toxicity >= grade following prior chemotherapy\r\n* Corrected QT (QTc) > for females and > for males
Severe, concurrent illness including congestive heart failure, significant cardiac disease and uncontrolled hypertension, that would likely prevent the patient from being able to comply with the study protocol
Clinically significant cardiovascular disease (eg, uncontrolled or any New York Heart Association Class or congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
Evidence of poor cardiovascular function defined as b-type natriuretic peptide (BNP) > pg/mL, or history of congestive heart failure, unstable angina, uncontrolled hypertension, or clinically significant ventricular arrhythmias at screening;
History of significant cardiac disease. Includes second/third degree heart block; significant ischemic heart disease; mean QTc interval > msec prior to study start; poorly controlled hypertension; congestive heart failure of NYHA Class II or worse
History or symptoms of cardiovascular disease (New York Heart Association [NYHA] class , , or ) within the last months, particularly coronary artery disease, arrhythmias, or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
The patient has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association [NYHA] Class or congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
Serious uncontrolled medical disorder or active systemic infection or current unstable or decompensated medical condition, which makes it undesirable or unsafe for the patient to participate in the study including: New York Heart Association (NYHA) Class or , myocardial infarction within months, uncontrolled angina within months, history of clinically significant ventricular arrhythmia, diabetes mellitus with ketoacidosis, or chronic obstructive pulmonary disease (COPD) requiring hospitalization in months prior to the start of treatment with PRI-.
Clinically significant, uncontrolled heart disease (e.g., unstable angina, congestive heart failure, uncontrolled hypertension, ventricular or atrial arrhythmias)
Any condition precluding exercise, including: New York Heart Association (NYHA) class II, III, or IV congestive heart failure, uncontrolled angina, myocardial infarction in the prior months, orthopedic surgery in the previous months or plans for orthopedic surgery during the study period, chronic pulmonary conditions such as uncontrolled asthma (symptoms > days/week) or dyspnea requiring oxygen, symptomatic peripheral vascular disease, symptomatic anemia, uncontrolled psychiatric conditions such as schizophrenia, or any other comorbidity that would interfere with the ability to complete and comply with the study protocol in the opinion of the investigator
Does not have clinically significant, symptomatic uncontrolled heart disease (e.g., unstable angina, congestive heart failure, or uncontrolled hypertension)
Has a serious concurrent medical condition, such as: congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening, -Lead electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant including myocardial infarction, angioplasty, or cardiac stent placement within the last months, HIV infection, known Hepatitis B or C infection. Subjects at high risk for Hepatitis B or C infection should have serology testing to rule out infection, a medical condition requiring the therapeutic use of anticoagulants.
Patients who are clinically unstable, patients who are seriously or terminally ill with a life expectancy of less than month, and patients whose clinical course are unpredictable; for example:\r\n* Patients on life support or in a critical care unit\r\n* Patients with unstable occlusive disease (e.g., crescendo angina)\r\n* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia\r\n* Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)\r\n* Patients with recent cerebral hemorrhage\r\n* Patients who have undergone surgery within hours prior to the study sonographic examination
PATIENT: Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:\r\n* Patients on life support or in a critical care unit\r\n* Patients with unstable occlusive disease (e.g., crescendo angina)\r\n* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia\r\n* Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)\r\n* Patients with recent cerebral hemorrhage\r\n* Patients who have undergone surgery within hours prior to the study sonographic examination
Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous months as confirmed by an electrocardiogram (ECG)
Subjects must not have an uncontrolled intercurrent illness, including an ongoing or active infection, current pneumonitis, symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, interstitial lung disease, active coagulopathy, or uncontrolled diabetes.
Clinically significant cardiopulmonary disease including uncontrolled or New York Heart Association (NYHA) class or congestive heart failure, uncontrolled angina, uncontrolled hypertension, uncontrolled arrhythmia, myocardial infarction or stroke within months of first protocol treatment, or corrected QT (QTc) > ms
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:\r\n* Patients on life support or in a critical care unit\r\n* Patients with unstable occlusive disease (eg, crescendo angina)\r\n* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia\r\n* Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous months as confirmed by an electrocardiogram (ECG)
Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous months as confirmed by an electrocardiogram (ECG)
The patient has New York Heart Association (NYHA) class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure.
Uncontrolled/significant heart disease