[c09aa8]: / clusters / clustall9k / 169.txt

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Patients must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] class III [moderate] or class IV [severe]) at the time of registration; baseline echocardiogram within 28 days of registration must demonstrate an ejection fraction (EF) >= 50%; patients must have corrected QT (QTc) interval < 500 msec on prestudy electrocardiogram (EKG) and no known history of congenital long QT syndrome; patients must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 3 months prior to registration and not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 6 months of registration; prestudy EKG must be obtained within 28 days prior to registration
History within 6 months prior to treatment of myocardial infarction, severe/unstable angina pectoris, coronary artery bypass grafting (CABG), New York Heart Association (NYHA) class III or IV congestive heart failure (CHF), stroke or transient ischemic attack (TIA)
History of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to day 1 of protocol therapy
Any of the following cardiovascular events within 6 months prior to study entry: myocardial infarction, malignant hypertension, severe/unstable angina, symptomatic congestive heart failure, cerebral vascular accident, or transient ischemic attack
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV (see Appendix 12.4) within 6 months prior to their first dose of study drug.
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of enfortumab vedotin.
Any of the following within 6 months before the enrollment:\r\n* Unstable angina pectoris;\r\n* Clinically-significant cardiac arrhythmias;\r\n* Stroke (including transient ischemic attack [TIA], or other ischemic event);\r\n* Myocardial infarction;\r\n* Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter [eg, vena cava filter] are not eligible for this study)
Absence of the following in the previous 6 months:\r\n* Myocardial infarction;\r\n* Unstable angina pectoris;\r\n* Clinically-significant cardiac arrhythmias;\r\n* Stroke (including transient ischemic attack [TIA], or other ischemic event);\r\n* Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter [eg, vena cava filter] are not eligible for this study)
Any of the following within 6 months before the first dose of study treatment:\r\n* Unstable angina pectoris\r\n* Clinically-significant cardiac arrhythmias\r\n* Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n* Myocardial infarction\r\n* Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study)
PHASE I AND II SCLC AND UROTHELIAL CARCINOMA EXPANSION COHORT: History of stroke, transient ischemic attack (TIA), or myocardial infarction, within 6 months prior to C1D1
mCRPC EXPANSION COHORT: Any of the following within 6 months before the first dose of study treatment:\r\n* Unstable angina pectoris\r\n* Stroke (including TIA, or other ischemic event)\r\n* Myocardial infarction
Arterial ischemic event (e.g., unstable angina, myocardial infarction, stroke) within 6 months of study entry
Known cardiac disease including any of the following:\r\n* New York Heart Association (NYHA) grade II or greater congestive heart failure\r\n* History of myocardial infarction or unstable angina within 6 months prior to day 1\r\n* History of stroke or transient ischemic attack within 6 months prior to day 1
Patients with any history of arterial thromboembolic disease; any patient with a history of myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina or peripheral vascular disease will not be eligible
Stroke, transient ischemic attack, unstable angina, myocardial infarction or congestive heart failure (New York Heart Association grade II or greater) within the past 12 months; unstable or severe intercurrent medical conditions, chronic renal disease, or uncontrolled diabetes mellitus
Active cardiac disease including any of the following:\r\n* New York Heart Association (NYHA) grade II or greater congestive heart failure\r\n* History of myocardial infarction or unstable angina within 6 months prior to day 1\r\n* History of stroke or transient ischemic attack within 6 months prior to day 1 of FOLFIRI + bevacizumab initiation
History of clinically significant vascular disease, including any of the following within 6 months prior to day 1 of study drug: myocardial infarction or unstable angina, percutaneous coronary intervention, bypass grafting, ventricular arrhythmia requiring medication, stroke or transient ischemic attack, symptomatic peripheral arterial disease and/or involvement of great vessels by tumor with or without vascular grafting
Participant has a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class (NYHA) III - IV within 6 months prior to their first dose of study drug.
History within 6 months prior to treatment of myocardial infarction, severe/unstable angina pectoris, coronary artery bypass graft (CABG), New York Heart Association (NYHA) class III or IV congestive heart failure (CHF), stroke or transient ischemic attack (TIA)
Patients with a history of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months are not eligible
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association class III-IV within 6 months prior to their first dose of the study drugs
History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, hospitalization for acutely decompensated congestive heart failure
Thrombosis or vascular ischemic events within the last six months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction
Patients who have had a myocardial infarction, transient ischemic attack, unstable angina, or cardiovascular symptoms (CVS) within 6 months before treatment
Clinical significant uncontrolled conditions â€\ active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 months prior to day 1
Patients with a history of myocardial infarction, unstable angina, stroke, or transient ischemic attack (TIA) within 6 months prior to planned day 1 of dosing are ineligible
Uncontrolled intercurrent illness including infection, congestive heart failure, myocardial infarction, transient ischemic attack or stroke within 6 months; any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary
Patients with a history of embolic events (e.g. transient ischemic attack [TIA]) from arrhythmia or peripheral arterial disease or of recent myocardial infarction (MI) whether or not treated with anti-platelet drugs
Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath with activity, or other heart conditions being treated by a doctor.
Any history of major myocardial infarction, stroke or transient ischemic attack (TIA); minor acute myocardial infarction (AMI) and patients who have had cardiac bypass free of symptoms for at least 2 years may be eligible at the discretion of the study chair
The subject has the following cardiac conditions: unstable angina pectoris, clinically significant cardiac arrhythmias, history of stroke (including transient ischemic attack [TIA], or other ischemic event) within 6 months of study treatment, myocardial infarction within 6 months of study treatment, history of thromboembolic event requiring therapeutic anticoagulation within 6 months of study treatment or main portal vein or vena cava thrombosis or occlusion; (Note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study)
History of a stroke or transient ischemic attack, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to the first dose of treatment.
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association class III-IV within 6 months prior to their first dose of brentuximab vedotin
Patients with either of the following within 6 months before the first dose of study treatment:\r\n* Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n* Myocardial infarction
Have a history of congestive heart failure with a New York Heart Association class greater than 2, unstable angina, recent myocardial infarction (within 6 months of study enrollment), transient ischemic attacks, stroke, or arterial or venous vascular disease
Thrombosis or vascular ischemic events within the last twelve months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction
Patients must not have recent (within six months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III/IV heart failure
Subjects with congestive heart failure are not eligible, nor are subjects with myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack (TIA) within the past 12 months, uncontrolled hypertension (systolic blood pressure [BP] > 160 or diastolic BP > 90), uncontrolled or symptomatic arrhythmia, or grade 2 or greater peripheral vascular disease
Active cardiovascular disease including any of the following:\r\n* New York Heart Association (NYHA) grade II or greater congestive heart failure\r\n* History of myocardial infarction or unstable angina within 6 months prior to day 1\r\n* History of stroke or transient ischemic attack within 6 months prior to day 1
History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA)
Atherosclerotic cardiovascular disease (ASCVD) defined by history of acute coronary syndromes, myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin
Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure
heart attack, acute (2 days) cardiac event or stroke in preceding six months,
Patient must not have a history of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure =< 6 months prior to study entry
Occurrence of heart attack, stroke, or angina in the past 3 months
Unstable angina, myocardial infarction, known or suspected transient ischemic events, or stroke within 24 weeks of start of Screening.
Patients with a history of any arterial thrombotic event within the past 6 months; this includes angina (stable or unstable), myocardial infarction (MI), transient ischemic attack (TIA), or cerebrovascular accident (CVA)
The patient has experienced any arterial thrombotic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment
Patients with a history of the following within =< 12 months of study entry are not eligible:\r\n* Arterial thromboembolic events\r\n* Unstable angina\r\n* Myocardial Infarction
Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion
Patients who have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment
History of arterial thrombotic disease, specifically including, but not restricted to: \r\n* Myocardial infarction or unstable angina\r\n* Cerebrovascular event (CVA) or transient ischemic attack (TIA)\r\n* Peripheral vascular disease or claudication
History of any arterial thromboembolic event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina within 6 months prior to enrollment
No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible \r\n* Patients who have experienced a deep venous thrombosis or pulmonary embolus within the past 6 months must be on stable therapeutic anticoagulation to be enrolled to this study
Recent (< 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction
Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to enrollment
Patients with arterial thrombotic events, such as cerebrovascular accident or myocardial infarction, within 6 months of enrollment
Arterial thromboembolic event including, but not limited to, myocardial infarction, transient ischemic attack, or cerebrovascular accident within 6 months of enrollment
History of any of the following:\r\n* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)\r\n* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial within 6 months prior to randomization\r\n* Venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks) within 6 months prior to randomization\r\n* Clinically significant ventricular arrhythmias within 6 months prior to randomization
Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
Significant arterial or venous thromboembolic disease or vascular disorders within 6 months prior to administration of first dose of study drug, including by not limited to:\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Peripheral ischemia > grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)\r\n* Arterial thrombotic event
Have clinically significant heart disease as evidenced by severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment
The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment
History of any of the following:\r\n* Seizure or known condition that may predispose to seizure (e.g., prior stroke within 1 year of randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)\r\n* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
History of any of the following:\r\n* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 6 months of cycle 1 day 1, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)\r\n* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to first dose of study drug; venous thrombotic events within 6 months are permitted IF they are not attributed to prostate cancer (in the opinion of the treating physician)
Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, =< 6 months prior to randomization
Any of the following within 6 months prior to randomization: Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias
Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration
Arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or MI within 6 months of study registration
No history of acute arterial thrombotic events within the past 6 months (including cerebrovascular accident [CVA], transient ischemic attack [TIA], myocardial infarction [MI], or unstable angina)
Have experienced any arterial or venothrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 6 months (?6 months) prior to randomization.
Recent (=< 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction
Arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) < 6 months prior to enrollment
Within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
Have experienced any arterial thrombotic event or arterial thromboembolic event, including myocardial infarction, unstable angina (history or evidence of current clinically relevant coronary artery disease of current ?Class III as defined by Canadian Cardiovascular Society Angina Grading Scale or congestive heart failure of current ?Class III as defined by the New York Heart Association), cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
Has a history of an arterial thromboembolic event within the prior six months including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina.
The participant experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
Arterial thrombotic events =< 6 months prior to randomization; Note: this includes transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI)
No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, myocardial infarction (MI), or unstable angina or angina requiring surgical or medical intervention in 6 months prior to registration; patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible; patients who have experienced a deep venous thrombosis or pulmonary embolus within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 6 weeks prior to enrollment of this study
Patients with a history of the following within =< 12 months of study entry are not eligible:\r\n* Arterial thromboembolic events\r\n* Unstable angina\r\n* Myocardial Infarction
History of an arterial thrombotic vascular event including cerebrovascular accident (CVA), myocardial infarction (MI), unstable angina, coronary or peripheral arterial bypass graft, or transient ischemic attack (TIA) within 6 months
History of arterial thrombotic events within 6 months before randomization, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (e.g., claudication with < 1 block) or any other arterial thrombotic event are also ineligible
Participant has experienced any arterial thromboembolic event (ATE), including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, within 6 months prior to receiving study drugs.
Has experienced any arterial thrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident within 6 months prior to randomization
No history of arterial thrombotic events within the past 6 months, including:\r\n* Transient ischemic attack (TIA)\r\n* Cerebrovascular accident (CVA)\r\n* Peripheral arterial thrombus\r\n* Unstable angina or angina requiring surgical or medial intervention\r\n* Myocardial infarction (MI)\r\n* Significant peripheral artery disease (i.e., claudication on less than one block)\r\n* Significant vascular disease (i.e., aortic aneurysm, history of aortic dissection)
Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, <6 months prior to randomization.