Uncontrolled blood pressure despite medical treatment
Patients with uncontrolled high blood pressure (i.e., systolic/diastolic blood pressure > 99th percentile) are not eligible
Blood pressure that is not controlled despite > 2 oral agents (systolic blood pressure [SBP] > 160 and diastolic blood pressure [DBP] > 90 documented during the screening period with no subsequent blood pressure readings > 160/100)
Blood pressure >140/80
Adequately controlled blood pressure
Patients must demonstrate adequately controlled blood pressure at the time of study entry, as defined by a blood pressure =< 150/100 mmHg at study screening on at least one of two screenings conducted at least 24 hours apart; if blood pressure meets these guidelines on initial measurement, no subsequent measurement for screening is needed; blood pressure may be assessed by automated or manual methods by an appropriately trained clinician or nurse
Participants with uncontrolled high blood pressure, defined as a blood pressure during screening of >= 160/100 despite medical management
Have poorly controlled hypertension defined as blood pressure >160/90 on at least 2 repeated determinations on separate days within 2 weeks (14 days) prior to initiation of screening
Normotensive or well controlled blood pressure (<140/90).
Unstable hypertension (blood pressure > 160/100)
Blood pressure less than 140/90 mm Hg with or without anti-hypertensive therapy\r\n* Patients may be rescreened after initial ineligibility if due to elevated blood pressure, if adequately medically managed within approximately 30 days
Patients must be willing and able to check and record daily blood pressure readings when randomized to cediranib containing arm
Patients with a diagnosis of hypertension are required to have adequate blood pressure control prior to enrollment, defined as blood pressure =< 140/90 mmHg
Has uncontrolled hypertension defined as blood pressure > 150/90 on medication(s) by 2 blood pressure readings taken at least 1 hour apart.
Uncontrolled hypertension (defined as average systolic blood pressure >= 140 or average diastolic blood pressure >= 90, with blood pressure measured >= 3 times in the two weeks prior to enrollment) or diabetes
Arterial blood gas partial pressure carbon dioxide (pCO2) < 50 mmHg
Patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to Arm III
Patients with high risk of cardiovascular event such as severe uncontrolled hypertension (> 170/110 systemic blood pressure on therapy), or pulmonary hypertension (greater than .5 systolic blood pressure)
Patients must have controlled blood pressure with a systolic blood pressure < 140 mmHg and diastolic < 90 mmHg (for patients with an elevated initial blood pressure (BP) reading [hypertensive range], a repeat measurement at least 2 minutes later should be performed, and the two readings should be averaged to obtain a BP reading); any hypertensive at-home blood pressure reading will be confirmed in clinic; patients on anti-hypertensive medications are eligible, if blood pressure is controlled; study drug dosing will be interrupted for any reading >= 160/100
Stable blood pressure and circulation, not requiring pressor support
Patients who are currently receiving a beta-blocker for another medical condition will be excluded from this study; patients with extremes of blood pressure (e.g., systolic blood pressure [SBP] > 150 or < 100) may be excluded from participation if the treating physician feels that this medical condition has not been adequately addressed by the patient’s primary care physician
Stable blood pressure and circulation not requiring pressor transport
Adequately controlled blood pressure
A common skin contaminant cultured from 2 or more blood cultures drawn on the same or consecutive calendar days from a subject with fever (greater than 38.0 degrees C), chills, or hypotension (systolic blood pressure less than 90 mmHg);
Symptoms of uncontrolled intracranial pressure
Uncontrolled arterial hypertension despite appropriate medical therapy (systolic blood pressure > 160 or diastolic blood pressure > 100)
Patients must be willing and able to check and record daily blood pressure readings if receiving cediranib
Inability to home monitor blood pressure
Blood pressure =< 140/90 within 10 days of registration (must be taken and recorded by a health care professional); Note: if the systolic blood pressure is > 140 and/or diastolic blood pressure is > 90 at the time of registration, the patient’s blood pressure must be controlled; systolic blood pressure must be < 140 and diastolic blood pressure must be < 90 on at least 2 separate measurements prior to the start of treatment, and the treating physician must believe that this is feasible in order to enroll the patient
Uncontrolled hypertension: systolic blood pressure >= 160, diastolic blood pressure >= 90
Have uncontrolled hypertension (systolic blood pressure greater than 150 or diastolic blood pressure greater than 100) or history of congestive heart failure (AHA Grade 2 or higher).
Adequately controlled blood pressure
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment\r\n* Sustained systolic blood pressure > 160 or diastolic blood pressure > 100 despite medical therapy; sustained blood sugar > 300 despite medical therapy\r\n* Chronic hypertension or diabetes on appropriate medical therapy does not constitute an exclusion criterion
Willingness and ability to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients
Controlled blood pressure (systolic blood pressure < 140 and diastolic blood pressure < 90) on no more than three anti-hypertensive agents; drug formulations containing two or more anti-hypertensive agents will be counted based on the number of active agents in each formulation
For patients with hypertension at baseline with a systolic pressure greater than 140 or a diastolic pressure greater than 90
Blood pressure < 160/90
Blood pressure that is not controlled despite > 2 oral agents (systolic blood pressure [SBP] > 160 and diastolic blood pressure [DBP] > 90 documented during the screening period with no subsequent blood pressure readings < 160/100)
No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart; the baseline systolic blood pressure readings must be =< 140, and the baseline diastolic blood pressure readings must be =< 90; patients whose hypertension is controlled by antihypertensive therapies are eligible
Patients must be willing and able to check and record daily blood pressure readings
Adult patients with hypertension not controlled by medical therapy (hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management); pediatric patients must have blood pressure (BP) within normal limits (WNL) for age; NOTE: blood pressure within the upper limit of normal is defined as: blood pressure =< the 95th percentile for age, height, and gender, and not be receiving medication for treatment of hypertension
Uncontrolled hypertension (blood pressure greater than 140/90 mmHg on at least 2 measurements on sequential visits, despite blood pressure medication)
A past history of, or current uncontrolled hypertension. Blood pressure must be adequately controlled prior to dosing with VS-5584.
The participant has high blood pressure or diabetes that is not well-controlled with medication
Uncontrolled hypertension (systolic blood pressure > 150 or diastolic blood pressure > 100)
Oxygen partial pressure (pO2) < 60% or carbon dioxide partial pressure (pCO2) >= 50 on room air arterial blood gas
Participants with uncontrolled sustained hypertension which will be defined as systolic blood pressure > 140, and diastolic blood pressure > 90, even with use of anti-hypertensive medications
Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac\n             arrhythmia)
Blood pressure greater than 170/90 or two standard deviations from normal based on age and weight nomogram on three separate measurements
Participants must have a baseline blood pressure of 160/90 or less; participants requiring medicines to control blood pressure are eligible
Uncontrolled arterial hypertension despite appropriate medical therapy (defined as systolic blood pressure > 160 or diastolic blood pressure > 100)
Abnormal systolic blood pressure, diastolic blood pressure and/or heart rate
Patients with New York Heart Association (NYHA) grade 2 or higher congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, or arterial thrombotic event with the past 12 months, uncontrolled hypertension (systolic blood pressure > 150 and/or diastolic blood pressure > 100 on antihypertensive medications; patients not on medication for high blood pressure who are found to have systolic blood pressure [SBP] > 150 and/or diastolic blood pressure [DBP] > 100 should have 3 documented episodes of elevated blood pressure before being considered ‘uncontrolled’, if they have 3 documented episodes of elevated blood pressure, then can be started on antihypertensive medications; patients currently on antihypertensive medications with elevated blood pressures as defined above may have their medications adjusted; if patients have persistent [3 episodes] of high blood pressure despite medication adjustment they will be considered ineligible for study participation; each measured episode should be 24 hours apart), prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled or clinically significant arrhythmia, grade II or greater peripheral vascular disease or prior history of stroke or transient ischemic attack (TIA); patient must have a pretreatment oncocardiology echocardiogram with left ventricular ejection fraction (LVEF) above lower limit of normal
Controlled blood pressure, defined as blood pressure =< 140/90 on average (3 separate readings taken at screening visit in a relaxed clinical environment and averaged)
Inability to home monitor blood pressure
Patients not achieving adequate blood pressure in spite of antihypertensive therapy for control of blood pressure
Patients must have normal blood pressure or well-controlled hypertension.
Poorly controlled high blood pressure
Severe untreated sleep apnea (treatment is defined as therapy with continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], adaptive servo ventilation [ASV], or other positive air pressure device)
Presence of conditions where significant elevations in blood pressure would be a serious hazard
Stage 2 hypertension or greater (systolic blood pressure > 160 and/or diastolic blood pressure > 100)
Resting blood pressure and/or heart rate within normal limits
Resting blood pressure and/or heart rate outside normal limits
Resting blood pressure > 160/100
Uncontrolled hypertension >= 2 times as noted in medical history (diastolic blood pressure > 100, systolic > 160) =< 90 days prior to registration
History of intolerance to negative pressure wound therapy
Use of any other blood pressure lowering medication for treatment of hypertension, within 30 days of randomization
Pressure readings >= 140/90 mm Hg, as defined by the 7th Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, will be deemed ineligible to participate and excluded from the study; they will be referred to their family physician or community services; those ineligible based on their initial blood pressure reading are allowed to participate if they provide a letter from a physician who will continue to monitor the participant during the research study
Uncontrolled hypertension (defined as blood pressure in adults > 150/95)\r\n* Patients on anti-hypertensive medications are eligible if blood pressure is controlled
Patients with a history of severely impaired autonomic control of blood pressure
Use of any other blood pressure lowering medication for treatment of hypertension within 30 days of enrollment except calcium channel blockers and diuretics
Uncontrolled severe hypertension at enrollment. Severe hypertension is defined as a systolic or diastolic blood pressure (BP) > 5 mm Hg above the 95th percentile as defined by the National High Blood Pressure Education Program Working Group (NHBPEP) established guidelines for the definition of normal and elevated blood pressure in children
High blood pressure
High blood pressure
Participants with a blood pressure >= 140/90 at the time of baseline testing
Blood pressure > 140/90 at baseline by home monitoring
Patients with hypertension not adequately controlled by medication (i.e. systolic blood pressure >= 150 and/or diastolic blood pressure >= 90 on at least two separate readings)
Uncontrolled high blood pressure (BP) >= 160/100; persons can be re-screened after controlled
high blood pressure (defined as systolic blood pressure over 165 or diastolic blood pressure over 100),
Poorly controlled hypertension, with blood pressure at study entry > 160/100; the addition of anti-hypertensives to control blood pressure is allowed for eligibility determination
Poorly controlled hypertension, with blood pressure at study entry > 160/100
Systolic blood pressure < 90 prior to propranolol
Current use of medications to control blood pressure or improve cardiac output
Systolic blood pressure greater than 145 and diastolic blood pressure greater than 90
Blood pressure <= Grade 1 (hypertensive participants are permitted if their blood pressure is controlled to <= Grade 1 by hypotensive medications and glycosylated HbA1C <= 6.5%).
Systolic blood pressure (BP) not deemed clinically controlled by the investigator.
No history of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis)
Uncontrolled hypertension
Patients with uncontrolled hypertension (>= 140/90 mmHg) are NOT eligible for participation
Uncontrolled hypertension
Patients with uncontrolled hypertension; patients with a history of hypertension must be well controlled (< 160/90) on a regimen of hypertensive medication
History of significant cardiac disease or uncontrolled hypertension
Patients with uncontrolled hypertension (> 140/90 mmHg) are NOT eligible for participation
Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
Uncontrolled hypertension
Uncontrolled hypertension
Uncontrolled hypertension
Uncontrolled hypertension
Has uncontrolled or poorly controlled hypertension
Uncontrolled hypertension
Uncontrolled hypertension (> 150/100 mmHg)
Hypertension that is not controlled by standard medication (to 150/90 mmHg or below),
Uncontrolled hypertension, i.e., blood pressure (BP) of >= 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or
Patients must not have uncontrolled hypertension
Uncontrolled hypertension (HTN)
Uncontrolled hypertension
Patients with uncontrolled hypertension
Hypertension that is unstable or not controlled by medication.
Uncontrolled hypertension
Patients with uncontrolled hypertension
Patients with uncontrolled hypertension (HTN) (> 160/90) will not be admitted onto the study
Criteria for hypertension: Blood pressure greater than 170/90 or 2 standard deviations (SD) from normal based on age and weight nomogram on 3 separate measurements; uncontrolled hypertension (HTN)
Patients must not have symptomatic hypertension
Severe or unstable cardiovascular disease or uncontrolled hypertension
Uncontrolled hypertension
Uncontrolled or severe hypertension, or cerebrovascular disease.
Patients with diagnosed uncontrolled hypertension (> 150/90 mmHg) are to be excluded
Patients with hypertension controlled with medications are allowed
Uncontrolled hypertension (refer to World Health Organization [WHO]-International Society of Hypertension [ISH] guidelines)
Uncontrolled hypertension, i.e., blood pressure (BP) of >= 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose and meet all other inclusion criteria; or
Uncontrolled hypertension defined as > 140/90 and not cleared for surgery at the time of consent
Uncontrolled hypertension
Have uncontrolled severe hypertension
Uncontrolled hypertension
DONOR: Current uncontrolled hypertension
Uncontrolled hypertension
Have a known history of uncontrolled hypertension. Patients with hypertension should be under treatment on study entry to control blood pressure.
Patients with >= grade 2 uncontrolled hypertension
Uncontrolled hypertension during screening
Current uncontrolled hypertension
Part 2: tachycardia and/or uncontrolled hypertension
Uncontrolled hypertension at study entry; patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by antihypertensive treatment
Uncontrolled hypertension
Uncontrolled hypertension
Hypertension that is not controlled by standard medication (to 150/90 mmHg or below)
Uncontrolled hypertension (> 150/90 mmHg)
Hypertension not adequately controlled by 3 or less medications
Hypertension not adequately controlled by 3 or less medications
Uncontrolled hypertension defined as > 140/90 and not cleared for surgery at the time of consent
Uncontrolled hypertension
Uncontrolled hypertension.
Poorly controlled hypertension
Patients must not have a diagnosis of uncontrolled seizure or uncontrolled hypertension
Have uncontrolled hypertension.
uncontrolled cardiovascular disease or uncontrolled hypertension
have uncontrolled hypertension
Hypertension defined below:
Uncontrolled hypertension
Uncontrolled or poorly controlled hypertension.
Severe or uncontrolled systemic diseases including uncontrolled hypertension
Uncontrolled hypertension.
Resisted hypertension
Uncontrolled hypertension, i.e., blood pressure (BP) of >= 170/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria
Controlled hypertension
Current uncontrolled hypertension
Uncontrolled hypertension
Inadequately controlled arterial hypertension
Uncontrolled hypertension
History or evidence of poorly controlled hypertension
Patients with uncontrolled hypertension (>= 145/90 mmHg) are NOT eligible for participation
Poorly controlled hypertension
Other clinically significant heart disease (e.g. uncontrolled hypertension, or history of labile hypertension)
Hypertension
Patients with poorly controlled hypertension
Subject has uncontrolled hypertension.
Uncontrolled hypertension defined as systolic greater than 180 and diastolic greater than 100
Uncontrolled hypertension
Uncontrolled hypertension
Inadequately controlled hypertension
Uncontrolled hypertension
Hypertension uncontrolled by medication
Uncontrolled hypertension
Known history of malignant hypertension (severe hypertension >180/120 mmHg with end organ involvement.
Uncontrolled hypertension, i.e., blood pressure (BP) of >= 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria
Uncontrolled hypertension (per the Investigator's discretion)
Uncontrolled concurrent medical illness including uncontrolled hypertension
Uncontrolled hypertension
Uncontrolled hypertension (per Investigator's discretion)
Uncontrolled hypertension
Poorly-controlled hypertension
Have >= Grade 2 uncontrolled hypertension
Uncontrolled hypertension or chronic renal disease
Uncontrolled hypertension;
Hypertension other than mild essential hypertension controlled with medication
Patients with uncontrolled hypertension.
Uncontrolled hypertension.
Have tachycardia and/or uncontrolled hypertension
Uncontrolled hypertension, i.e., blood pressure (BP) of >= 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or
Has untreated hypertension or has hypertension under treatment that meets protocol definitions.
uncontrolled hypertension
Patient has uncontrolled hypertension
History of Uncontrolled hypertension
Well-controlled hypertension
Uncontrolled hypertension
Uncontrolled hypertension.
Clinically uncontrolled hypertension in the investigator's opinion (e.g., blood pressure >160/100 mmHg; note that isolated elevated readings considered to not be indicative of uncontrolled hypertension are allowed). The following within 6 months prior to Cycle 1 Day 1:
Patients must not have inadequately controlled hypertension; patients must have documented blood pressures of systolic blood pressure (SBP) < 150 and diastolic blood pressure (DBP) < 90 within 14 days of starting randomization; blood pressure medications (any number) are permitted
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg); Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement; these three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure; the mean SBP / DBP ratio must be < 140/90 mmHg in order for a subject to be eligible for the study
Poorly-controlled hypertension as defined blood pressure (BP) > 150/100 mmHg, or systolic blood pressure (SBP) > 180 mmHg when diastolic blood pressure (DBP) < 90 mmHg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment
Patients with uncontrolled hypertension as defined as systolic blood pressure of > 140 mmHg or diastolic blood pressure of > 90 mmHg documented on 2 consecutive measurements taken at least 24 hours apart are not eligible; Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement; these three values will be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure; the mean systolic blood pressure (SBP)/diastolic blood pressure (DBP) ratio must be < 140/90 mmHg in order for a subject to be eligible for the study
Inadequately controlled hypertension (ie, systolic blood pressure [SBP] >160 mmHg or diastolic BP [DBP] >90 mmHg) at 2 separate measurements no more than 60 minutes apart during the Screening visit. Note: patients may be rescreened after adjustment of antihypertensive medications.
Poorly controlled hypertension (systolic blood pressure [SBP] > 150 or diastolic blood pressure [DBP] > 90 despite antihypertensive therapy)
Men with baseline systolic blood pressure (SBP) < 110 or heart rate (HR) < 60
Inadequately controlled hypertension (defined as persistent systolic blood pressure (SBP) > 150 and/or diastolic blood pressure (DBP) > 100 mmHg)
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of > 150 mmHg or diastolic blood pressure [DBP] of > 90 mmHg)
To be performed within 10 business days prior to day 1: In patients who are to receive VRP, base systolic blood pressure (SBP) > 110; diastolic blood pressure (DBP) > 60 and baseline heart rate > 60
Systolic blood pressure (SBP) > 160 mmHg or < 90 mmHg at screening; if initial screening SBP is outside of the eligible range, blood pressure may be re-checked after intervention; SBP must be documented as stable and within the eligible range prior to starting study drug
Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of < 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since presentation;
Uncontrolled hypertension as defined by systolic blood pressure (SBP) > 150 or diastolic blood pressure (DBP) > 90 on at least two separate occasions documented in the medical record; patients would be eligible if blood pressure is controlled with appropriate anti-hypertensive therapy; rescreening after this therapy has been instituted is allowed
Uncontrolled hypertension, systolic blood pressure (SBP) > 160 or diastolic blood pressure (DBP) > 100
Uncontrolled hypertension (systolic blood pressure [SBP] > 170/diastolic blood pressure [DBP] > 105)
Have uncontrolled hypertension (i.e., >150 and >90 for systolic blood pressure (SBP) and diastolic blood pressure (DBP) respectively). Participants with hypertension should be under treatment at study entry to ensure blood pressure control. Those requiring 3 or more antihypertensive medications should be discussed with the medical monitor.
Patients must not have uncontrolled hypertension as defined by systolic blood pressure (SBP) >= 160 mmHg or diastolic blood pressure (DBP) >= 90 mmHg; patients whose blood pressure can be controlled medically are allowed to be rescreened once blood pressure (BP) is under control
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAdequately controlled blood pressure (systolic blood pressure [SBP] < 140 mmHg and diastolic blood pressure [DBP] < 90 mmHg) on a maximum of three antihypertensive medications
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nAdequately controlled blood pressure (SBP < 140 mm Hg and DBP < 90mmHg) on a maximum of three anti-hypertensive medications
Systolic blood pressure (SBP) > 90 (or within 10% of their baseline SBP) and diastolic blood pressure > 50 (or within 10% of their baseline diastolic blood pressure [DBP]) at time of harvest
Uncontrolled hypertension (systolic blood pressure; [SBP] greater than 180 or diastolic blood pressure; [DBP] greater than 110)
Poorly controlled hypertension (defined as systolic blood pressure of >= 160 mmHg or diastolic blood pressure of >= 90 mmHg); Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure must be reassessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between antihypertensive medication initiation or adjustment and blood pressure measurement; these three values should be averaged to obtain the mean diastolic and systolic blood pressures, which must be < 140/90 mmHg in order for a patient to be eligible for the study
Uncontrolled hypertension (systolic blood pressure [SBP] equal to or more than 140 or diastolic blood pressure [DBP] equal to or more than 90)
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg); note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement; these three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure; the mean SBP/DBP ratio must be < 140/90 mmHg
Inadequately controlled hypertension (systolic blood pressure [SBP] > 150mmHg, diastolic blood pressure [DBP] > 100mg Hg)
Patients with systolic blood pressure (SBP) >= 140 mmHg or diastolic blood pressure (DBP) >= 90 mmHg at the screening visit are ineligible; patients with an initial clinic blood pressure (BP) >= 140/90 mmHg may be included if SBP < 140 mmHg and DBP < 90 mmHg is confirmed in two subsequent BP measurements on the same day
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 150 mmHg and/or diastolic blood pressure [DBP] of >= 90 mmHg); Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study registration
No uncontrolled or poorly controlled hypertension despite standard medical management(e.g., consistently systolic blood pressure [SBP] > 160 and diastolic blood pressure [DBP] > 90 mmHg)
Poorly controlled hypertension (defined as systolic blood pressure [systolic blood pressure (SBP) of >= 150 mmHg or diastolic blood pressure (DBP)] of >= 90 mmHg)
Poorly controlled hypertension, defined as systolic blood pressure (SBP) of >= 140 mmHg or diastolic blood pressure (DBP) of >= 90mmHg; Note: screening/baseline blood pressure (BP) must be assessed with three measurements at approximately 2-minute intervals; the mean SBP/DBP values from the three readings must be < 140/90 mmHg in order for a subject to be eligible for the study; if the subject’s initial screening SBP/DBP is >= 140/90 mmHg, initiation or adjustment of antihypertensive medication(s) is permitted in an attempt to control the subject’s BP level to below 140/90 mmHg; optimal blood pressure control must be achieved before registration and monitored
Poorly controlled hypertension (defined as systolic blood pressure of >= 140 mmHg or diastolic blood pressure of >= 90 mmHg); Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure must be reassessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between antihypertensive medication initiation or adjustment and blood pressure measurement; these three values should be averaged to obtain the mean diastolic and systolic blood pressures, which must be < 140/90 mmHg in order for a patient to be eligible for the study
Systolic Blood Pressure (SBP) >160 or <90 mmHg
Uncontrolled blood pressure and hypertension: systolic blood pressure (SBP) > 140 mm Hg or diastolic blood pressure (DBP) > 90 mm Hg within 14 days prior to registration; patients are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study); all blood pressure measurements within the 14 days prior to registration and on day 1 of cycle 1 must be SBP =< 140 and DBP =< 90; an exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a normal blood pressure
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study as so judged by the treating physician; examples include but are not limited to:\r\n* Severely impaired lung function (e.g. use of home O2, history of idiopathic lung disease [ILD], any evidence of ILD on scan)\r\n* Active (acute or chronic) severe infections requiring treatment with I.V. antibiotics\r\n* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90 mmHg); NOTE: initiation or adjustment of anti-hypertensive medication(s) is permitted prior to study entry; following anti-hypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement; these three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure; the mean SBP/DBP ratio must be < 140/90 mmHg in order for a subject to be eligible for the study
Uncontrolled hypertension (systolic blood pressure [SBP] > 170/ diastolic blood pressure [DBP] > 105)
Patients with uncontrolled hypertension (systolic blood pressure [SBP] > 155, diastolic blood pressure [DBP] > 90), unstable coronary disease (unstable angina, evidence of congestive heart failure [CHF], or myocardial infarction [MI] within 6 months of study)
Patient with impaired cardiac function or any clinically significant uncontrolled cardiac disease, and/or, cardiac repolarization abnormality, including any of the following: Clinically significant heart disease such as CHF requiring treatment (NYH grade ? 2), history of angina pectoris, myocardial infarction, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry, documented cardiomyopathy, or left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO). Uncontrolled systolic blood pressure (SBP) ?160 mmHg and/or diastolic blood pressure (DBP) ?100 mmHg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to screening, Systolic blood pressure (SBP) <90 mmHg Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by central laboratory
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90 mmHg)\r\nNote: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement; these three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure; the mean SBP / DBP ratio must be < 140/90 mmHg (or 150/90 mm Hg, if approved by principal investigator [PI] and the quality assurance monitor [QAM]) in order for a patient to be eligible for the study
Has existing uncontrolled arterial hypertension (systolic blood pressure [SBP] ?150 mmHg or diastolic blood pressure [DBP] ?100 mmHg) despite appropriate medical therapy
History of any one or more of the following cardiovascular conditions within the past 6 months: \r\n* Cardiac angioplasty or stenting \r\n* Myocardial infarction \r\n* Unstable angina \r\n* Coronary artery bypass graft surgery \r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)\r\n* Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >=140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg); Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be =< 140/90 mmHg in order for a subject to be eligible for the study\r\n* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; Note: subjects with recent DVT who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible
Uncontrolled hypertension (systolic blood pressure [SBP] > 170/diastolic blood pressure [DBP] > 105)
No evidence of preexisting uncontrolled hypertension; if the patient has a history of or elevated blood pressure at baseline then they must have controlled hypertension documented and confirmed by 2 consecutive blood pressure readings taken within 1 hour; the baseline systolic blood pressure readings must be =< 140 mm Hg, and the baseline diastolic blood pressure readings must be =< 90 mm Hg\r\n* Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement; these three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure; the mean systolic blood pressure (SBP)/diastolic blood pressure (DBP) ratio must be < 140/90 mmHg (OR 150/90 mm Hg, if this criterion is approved by the Huntsman Cancer Institute [HCI] Data Safety Monitoring Committee [DSMC] Chair or Co-chair) in order for a subject to be eligible for the study
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 150 mmHg or diastolic blood pressure [DBP] of >= 90 mmHg); Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be < 150/90 mmHg in order for a subject to be eligible for the study
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90 mmHg); Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be < 140/90 mmHg in order for a subject to be eligible for the study
Systolic blood pressure (SBP) > 110 mmHg; diastolic blood pressure (DBP) >= 60 mmHg
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg); Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure must be re-assessed prior to start of study therapy; the mean SBP/DBP values must be < 140/90 mmHg (OR 150/90 mmHg, if this criterion is approved by Safety Review Team) in order for a subject to be eligible for the study
Uncontrolled hypertension defined by systolic blood pressure (SBP) > 140 or diastolic blood pressure (DBP) > 90 despite titration of anti-hypertensive medications
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90 mmHg); Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be < 140/90 mmHg in order for a subject to be eligible for the study
Hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg OR diastolic blood pressure [DBP] of >= 90 mmHg) in spite of optimal medical management; note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; in this event, blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP/DBP values from each BP assessment must be < 140/90 mmHg in order for a subject to be eligible for the study
Inadequately controlled hypertension (i.e. systolic blood pressure [SBP] > 180 mmHg or diastolic blood pressure [DBP] > 100 mmHg)
Uncontrolled hypertension (defined as systolic blood pressure [SBP] and/or diastolic blood pressure [DBP] > 95th percentile for age)
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg); initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure must be re-assessed on two occasions that are separated by a minimum of 24 hours; the mean SBP/DBP values from each blood pressure assessment must be < 140/90 mmHg in order for a subject to be eligible for the study
EXPANSION COHORT ONLY: Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg); initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure must be re-assessed on two occasions that are separated by a minimum of 24 hours; the mean SBP/DBP values from each blood pressure assessment must be < 140/90 mmHg in order for a subject to be eligible for the study
Hypertension, defined for adults by SBP ? 160 mmHg and/or DBP ? 100 mmHg at baseline (or screening if baseline visit is skipped), and for pediatric patients by blood pressure greater than the 95th percentile for age, sex, and height (see Table 16-1). Additionally, patients who were started on antihypertensive medication after HSCT or who have received additional antihypertensive medication after HSCT will be eligible, even if they don't have elevated blood pressure.
Uncontrolled hypertension defined by a systolic blood pressure (SBP) > 150 and/or a diastolic blood pressure (DBP) > 100 mm Hg with or without anti-hypertensive medication
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of ? 150 mmHg or diastolic blood pressure [DBP] of ? 90 mmHg) on more than one occasion
Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ? 140 mmHg or diastolic blood pressure (DBP) of ? 90mmHg].
Hypertension: systolic blood pressure (SBP) > 150 or diastolic blood pressure (DBP) > 100 mm mercury (Hg) despite antihypertensive medications
Uncontrolled hypertension, defined as SBP ? 140 mmHg and/or DBP ? 90 mmHg with optimized anti-hypertensive therapy
Grade 3 hypertension (systolic blood pressure [SBP] >= 160 mmHg and/or diastolic blood pressure [DBP] >= 100 mmHg despite maximal medical therapy)
Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 150 mmHg or diastolic blood pressure [DBP] of >= 90 mmHg); Note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; blood pressure must be re-assessed on two occasions that are separated by a minimum of 24 hours; the mean SBP/DBP values from each blood pressure assessment must be =< 150 systolic and 90 diastolic mmHg in order for a subject to be eligible for the study
Uncontrolled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90 mmHg)
Poorly controlled hypertension (systolic blood pressure [SBP] >= 140 mmHg or diastolic blood pressure [DBP] >= 90 mmHg); the initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry
Uncontrolled hypertension (systolic blood pressure [SBP] greater than 180 or diastolic blood pressure [DBP] greater than 110)
Uncontrolled hypertension (systolic blood pressure; SBP greater than 180 or diastolic blood pressure; DBP greater than 110)
Patient must not have poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg)\r\n* Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be < 140/90 mmHg in order for a subject to be eligible for the study prior to study enrollment)
Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ? 160 mmHg and/or Diastolic Blood Pressure (DBP) ? 100 mmHg, with or without anti-hypertensive medication.
For subjects planned to potentially receive bevacizumab, they have no evidence of uncontrolled hypertension (defined as a blood pressure of ? 150 mm Hg systolic and/or ? 100 mm Hg diastolic on medication) or active GI perforation
Uncontrolled hypertension defined as systolic > 150 or diastolic > 100 mm Hg on the average of the 3 most recent BP readings. Anti-hypertensives may be started prior to randomization.
Significant active cardiovascular or pulmonary disease at the time of study entry, including\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg) \r\n* Pulmonary hypertension  \r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air   \r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement  \r\n* Medically significant (symptomatic) bradycardia
Patients with known significant active cardiovascular or pulmonary disease at the time of study entry are INELIGIBLE including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air\r\n* QT syndrome, or torsades de pointes\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long
Systolic blood pressure (BP) =< 150 mg HG
Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment; if severe hearing impairment is measured or if significant neuropathy is reported at baseline the treating physician will discuss the risks for further permanent hearing loss and neuropathy with the patient
Patients with persistently uncontrolled hypertension (systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical therapy
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) on repeated measurement) despite optimal medical management
Significant active cardiovascular or pulmonary disease at the time of study registration, including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 160 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Uncontrolled hypertension (diastolic blood pressure > 90 mm Hg; systolic > 140 mm Hg); patients with hypertension should be under treatment on study entry to effect blood pressure control
Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of antihypertensive agents to control hypertension before week 1, day 1 is allowed.
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE v4.0)] on repeated measurement) despite optimal medical management
Significant active cardiovascular or pulmonary disease at the time of study entry, including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas (ABG) analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg)
The patient has uncontrolled hypertension defined as a blood pressure measurement greater than 150 mm Hg systolic or 90 mm Hg diastolic with medication
Uncontrolled hypertension (systolic pressure >140 mm Hg and/or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.0] on repeated measurement) despite optimal medical management
Uncontrolled hypertension (above 150/95 mm Hg)
Significant active cardiovascular or pulmonary disease including: a) Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed. b) Pulmonary hypertension c) Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air d) Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement e) Medically significant (symptomatic) bradycardia f) History of arrhythmia requiring an implantable cardiac defibrillator g) Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes).
Has inadequately controlled hypertension (defined as systolic blood pressure greater than 150 mm Hg or diastolic blood pressure greater than 95 mm Hg); the use of antihypertensive medications to control blood pressure is permitted; retesting is permitted
Absence of uncontrolled angina or hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg on repeated measurement) despite optimal medical management
Hypertension defined as blood pressure (BP) systolic > 150 or diastolic > 90 mm Hg (Note: Initiation or adjustment of antihypertensive medication prior to study entry is allowed provided that the average of 3 BP readings prior to study treatment is ?150/90 mm Hg.)
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0] on repeated measurement) despite optimal medical management
Sustained systolic blood pressure (BP) >140 mm Hg or <90 mm Hg, diastolic BP >100 mm Hg or <60 mm Hg
Patients must not have uncontrolled hypertension (systolic >180 mm hg or diastolic > 100 mg Hg), angina pectoris, cardiac dysrhythmia, or recent (within 6 weeks) intracranial hemorrhage.
Hypertension defined as sustained BP > 140 millimeter of mercury (mm Hg) systolic, or > 90 mm Hg diastolic within 7 days before the first dose of study treatment and/or receiving medication to treat hypertension
Uncontrolled hypertension (that is, either systolic blood pressure > 180 millimeter of mercury [mm Hg] or diastolic blood pressure > 95 mm Hg).
Significant active cardiovascular or pulmonary disease at the time of study entry, including: uncontrolled high blood pressure (i.e., systolic blood pressure > 150 mm Hg, diastolic blood pressure > 90 mm Hg); use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed; pulmonary hypertension; uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air; significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement; medically significant (symptomatic) bradycardia; history of arrhythmia requiring an implantable cardiac defibrillator; baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Significant active cardiovascular or pulmonary disease including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Systolic blood pressure >140mm Hg or diastolic blood pressure > 90 mm Hg
Clinically significant cardiovascular disease defined as follows: \r\n* Inadequately controlled hypertension (i.e., systolic blood pressure [SBP] > 160 mm Hg and/or diastolic pressure [DBP] > 90 mm Hg despite antihypertensive therapy) \r\n* History of cerebrovascular accident (CVA) within 6 months \r\n* Myocardial infarction or unstable angina within 6 months
No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 30 minutes apart; the baseline systolic blood pressure readings must be =< 140 mm Hg, and the baseline diastolic blood pressure readings must be =< 90 mm Hg; patients whose hypertension is controlled by antihypertensive therapies are eligible
Significant active cardiovascular or pulmonary disease at the time of study entry, including: uncontrolled high blood pressure (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed; pulmonary hypertension; uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air; significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement; medically significant (symptomatic) bradycardia; history of arrhythmia requiring an implantable cardiac defibrillator; baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Significant active cardiovascular or pulmonary disease including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging\r\nindependent of symptom control with medical intervention, or history of valve\r\nreplacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Systolic blood pressure =< 160 mg Hg or diastolic pressure =< 90 mg Hg within 14 days prior to study registration
Significant active cardiovascular or pulmonary disease at the time of study entry, including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsade de pointes)
Pre-existing uncontrolled hypertension defined as > 150/90 mm Hg with medication
Poorly controlled arterial hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg), with or without antihypertensive medication; patients presenting with high blood pressure are eligible if the dose or adjustment of anti-hypertensive lowers blood pressure to meet the inclusion criteria of the study
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management
Uncontrolled hypertension (systolic blood pressure > 140 mm Hg and diastolic blood pressure of > 90 mm Hg which cannot be controlled by anti-hypertensive therapy), congestive heart failure (CHF), or other major medical illness
Clinically significant, uncontrolled intercurrent illness including, but not limited to:\r\n* Symptomatic or active infection\r\n* Uncontrolled hypertension (diastolic blood pressure > 90 mm Hg; systolic > 140 mm Hg); patients with hypertension should be under treatment on study entry to effect blood pressure control\r\n* Psychiatric illness/social situations that would limit compliance with study requirements
Significant active cardiovascular or pulmonary disease at the time of study entry, including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 150 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator
Uncontrolled hypertension as defined by SBP > 160 mm/Hg or DBP > 100 mm/Hg despite medical therapy.
Systolic blood pressure =< 160 mg Hg or diastolic pressure =< 90 mg Hg within 14 days prior to registration
Systolic blood pressure (BP) > 160 mm Hg or diastolic pressure > 100 mm Hg despite optimal medical management
Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening
Uncontrolled high blood pressure (ie, systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)
Uncontrolled hypertension defined as an average systolic blood pressure of >= 140 mm Hg or an average diastolic pressure >= 95 mm Hg
Have diastolic blood pressure of > 90 mm Hg resting at baseline despite medication.
Systolic blood pressure =< 100 mm Hg at baseline, diastolic =< 60 mm Hg at baseline within 4 weeks prior to start of any therapy
Treatment refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management
Uncontrolled hypertension (systolic pressure >= 140 mm Hg or diastolic pressure >= 90 mm Hg on repeated measurement) despite optimal medical management
Baseline blood pressure must be adequately controlled with or without antihypertensive medications prior to enrollment (systolic =< 150 mm Hg, diastolic =< 90 mm Hg)
Uncontrolled hypertension, defined as systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg, despite optimal medical management
Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg
Uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)
Uncontrolled cardiovascular conditions of hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage
Has poorly controlled hypertension defined as systolic blood pressure (SBP) ?150 mm Hg and/or diastolic blood pressure (DBP) ?90 mm Hg.
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0)] on repeated measurement) despite optimal medical management
Uncontrolled hypertension (ie, either systolic blood pressure greater than [>] 160 millimeter of mercury [mm Hg]; diastolic blood pressure >95 mm Hg). Use of anti-hypertensive agents to control hypertension before Cycle 1 Day 1 is allowed;
Have an uncontrolled arterial hypertension with systolic blood pressure ?150 or diastolic blood pressure ?90 millimeters of mercury (mm Hg) despite standard medical management.
Patients who are ? 18 years of age must have a systolic blood pressure that is > 160 or diastolic < 90 mm of Hg at the time of enrollment
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03] on repeated measurement) despite optimal medical management.
Uncontrolled hypertension, defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm Hg despite antihypertensive medications.
Treatment refractory hypertension systolic blood pressure (SBP) > 140 mm Hg and/or diastolic blood pressure (DBP) > 90 mm Hg
Uncontrolled hypertension (mean systolic blood pressure [BP] >= 160 mm Hg and/or mean diastolic BP >= 100 mm Hg on 3 determinations 5 minutes apart while on 2 anti-hypertensive agents) or hypertension requiring treatment with more than 2 anti-hypertensive agents
Clinically significant cardiac disease such as history of ventricular arrhythmia requiring therapy, currently uncontrolled hypertension (defined as persistent systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications), or any history of symptomatic CHF
Significant active cardiovascular or pulmonary disease at the time of study entry,\r\nincluding:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Pulmonary hypertension\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by ABG (arterial blood gas) analysis or pulse oximetry on room air\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement\r\n* Medically significant (symptomatic) bradycardia\r\n* History of arrhythmia requiring an implantable cardiac defibrillator\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management
Has inadequately controlled hypertension (defined as systolic blood pressure greater than 150 mm Hg or diastolic blood pressure greater than 95 mm Hg); the use of antihypertensive medications to control blood pressure is permitted
Clinically uncontrolled hypertension (diastolic blood pressure > 90 mm mercury [Hg]; systolic > 140 mm Hg); Note: patients with hypertension should be undergoing treatment at study entry for blood pressure control
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg on repeated measurement) despite optimal medical management per physician discretion
Poorly controlled hypertension (e.g. systolic >160milimiter (mm) Mercury (Hg) or diastolic >100mm Hg)
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management
Uncontrolled hypertension (defined as blood pressure > 140/90 mm Hg not controlled with anti-hypertensives)
Sustained systolic blood pressure (BP) >140 mm Hg or <90 mm Hg, diastolic BP >100 mm Hg or <60 mm Hg
Moderate or severe pulmonary hypertension defined as pulmonary arterial systolic pressure (PASP) > 50 mm Hg
Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)
Patients must not have uncontrolled hypertension (defined as systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg which cannot be controlled by anti-hypertensive therapy)
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management
Systolic blood pressure > 100 mm/Hg
Patients with a history of hypertension must have blood pressure that is adequately controlled on antihypertensives; (< 140/90 mm Hg)
Baseline systolic blood pressure (SBP) > 100 mm Hg; this is based on the average of two values-separate seated, resting measurements taken five minutes apart; blood pressure (BP) does not need to be checked in both arms unless a reading is below 110 mm Hg, in which case the other arm can be checked as well; if BP is checked in both arms, the higher value is deemed accurate for calculating the average
Patients cannot have baseline hypotension, defined as systolic BP lower than 100 mm Hg on two readings obtained on two separate days prior to study enrollment
Patients must have a systolic blood pressure =< 150 mm Hg and diastolic blood pressure =< 100 mm Hg (the use of antihypertensive medications to achieve these goals is allowed)
Uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg
Uncontrolled intercurrent illness including, but not limited to:\r\n* Uncontrolled hypertension (for the purpose of this trial, well-controlled hypertension is defined as systolic blood pressure of < 140 mm Hg and diastolic pressure < 90 mm Hg)\r\n** NOTE: the use of anti-hypertensive medication to control hypertension is permitted, provided it is not noted as a prohibited med elsewhere in protocol\r\n* Ongoing or active infection\r\n* Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or \r\n* Psychiatric illness/social situations that would limit compliance with study requirements
Poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic > 100 mm Hg)
Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg on medication)
Clinically significant cardio-vascular disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension (defined as persistent systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications), or any history of symptomatic congestive heart failure (CHF)
Blood pressure\r\n* Systolic blood pressure (SBP) < 150 mm/Hg\r\n* Diastolic blood pressure (DBP) < 90 mm/Hg
Patients must not have uncontrolled hypertension as defined by systolic blood pressure >= 150 mm Hg or diastolic blood pressure >= 90 mm Hg; patient may be eligible once hypertension is adequately controlled with medications
Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening;
History of newly diagnosed or uncontrolled glaucoma/intraocular pressure > 21 mm Hg as measured by tonography
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management
Uncontrolled hypertension (systolic pressure > 140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on mean of 3 consecutive readings despite optimal medical management; hypertension may be corrected by adding or adjusting antihypertensives prior to the initiation of treatment at the discretion of the practitioner
Uncontrolled glaucoma with intra-ocular pressures >21mm Hg
Has NYHA Class III or IV heart failure or uncontrolled hypertension (SBP ?160 mm Hg; DBP ?100 mm Hg).
Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication
The subject has uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment (BP must be controlled at screening)
Hypertension which is not controlled to systolic < 160 mm Hg and diastolic < 90 mm Hg;
Inadequately controlled hypertension defined as BP > 150/100 mm Hg despite medication
Uncontrolled hypertension, defined as systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg, despite medical management
Uncontrolled glaucoma with intraocular pressure greater than (>) 21 millimeters of mercury (mm Hg)
Treatment refractory hypertension defined as a blood pressure of systolic >140 mmHg and/or diastolic >90 mm Hg which cannot be controlled by anti-hypertensive therapy
The patient has uncontrolled hypertension despite adequate therapy (ie, systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
Blood pressure > 140/90 mm/Hg on average (3 separate readings taken at screening visit in a relaxed clinical environment and averaged)
Supine systolic blood pressure < 90 mm Hg, or symptomatic orthostatic hypotension, or a decrease in systolic blood pressure upon standing of > 20 mm Hg despite medical management (e.g. midodrine, fludrocortisones)
No history of uncontrolled hypertension (blood pressure > 160/100 mm Hg despite anti-hypertensive medication)
Hypertension not controlled by medical therapy (systolic blood pressure greater than 150 mm Hg or diastolic blood pressure greater than 100 mm Hg)
Uncontrolled hypertension, defined as systolic > 140 mm Hg or diastolic > 90 mm Hg
Intraocular pressure greater than 21mm Hg as measured by tonography.
Treatment refractory hypertension defined as a blood pressure of systolic> 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy
Significant active cardiovascular or pulmonary disease including:\r\n* Uncontrolled hypertension (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg); use of anti-hypertensive agents to control hypertension before cycle1 day 1 is allowed,\r\n* Pulmonary hypertension,\r\n* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air,\r\n* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement,\r\n* Medically significant (symptomatic) bradycardia,\r\n* History of arrhythmia requiring an implantable cardiac defibrillator,\r\n* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes)
Clinically significant hypotension (systolic blood pressure [SBP] < 80 mm HG or symptomatic)
Systolic blood pressure =< 160 mg Hg or diastolic pressure =< 90 mg Hg within 14 days prior to registration
Patients must have a systolic blood pressure >= 80 mm Hg within 14 days prior to registration
Patients with systolic blood pressure < 90 mm Hg
Uncontrolled hypertension (defined by a SBP ? 160 mm Hg or DBP ? 100 mm Hg while on anti-hypertensive medications) within 14 days prior to registration.
Low resting systolic blood pressure: < 90 mm hemoglobin (Hg)
Resting systolic blood pressure (SBP) > 180 mm HG and/or diastolic blood pressure (DBP) > 100 mm HG, or resting heart rate > 100 beats per minute at the baseline assessment
Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0] on repeated measurement) despite optimal medical management
Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or diastolic pressure of > or = to 90 mm Hg).
Sitting systolic BP > 90 mm Hg
No history of hypotension (defined as resting systolic blood pressure of < 110 mm Hg or diastolic blood pressure of < 70 mm Hg) or orthostasis (defined as drop in systolic blood pressure of > 20 mm Hg or increase in HR of > 20 from supine to standing position)
Patients with resting hypotension (blood pressure [BP] < 90/50 mm Hg), or resting hypertension (BP > 170/110 mm Hg) at screening
Within the past month:\r\n* Heart attack\r\n* Unstable or stable angina (cardiac chest pain)\r\n* Left main coronary artery disease\r\n* Symptomatic heart failure\r\n* Uncontrolled hypertension (systolic blood pressure [SBP] > 180 mm Hg or diastolic blood pressure [DBP] > 100mm Hg)\r\n* Severe valvular heart disease\r\n* Uncontrolled metabolic disease (diabetes with fasting blood sugar [BS] > 300 mg/dl, thyrotoxicosis, myxedema)\r\n* Aortic aneurism (> 45 mm diameter) or aortic dissection\r\n* Hypertrophic obstructive cardiomyopathy
Uncontrolled hypertension (blood pressure > 160/95 mm Hg)
Participants must not have blood pressure < 95 mm Hg systolic
Have at least one other component of metabolic syndrome reported below:\r\n* Elevated triglycerides (>= 150 mg/dL [1.7 mmol/L]) or on drug treatment for elevated triglycerides \r\n* Reduced high-density lipoprotein-cholesterol (HDL-C) (< 50 mg/dL [1.3 mmol/L]) or on drug treatment for reduced HDL-C\r\n* Elevated blood pressure (>= 130 mm mercury [Hg] systolic blood pressure or >= 85 mm Hg diastolic blood pressure) or on antihypertensive drug treatment in a patient with a history of hypertension\r\n* Elevated fasting glucose (>= 100 mg/dL)
Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm mercury [Hg] or diastolic blood pressure greater than 100 mm Hg)
Poorly controlled hypertension, defined as systolic blood pressure at study entry greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg; the addition of anti-hypertensives to control blood pressure is allowed
Poorly controlled hypertension, defined as systolic blood pressure at study entry greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg; the addition of anti-hypertensives to control blood pressure is allowed
Uncontrolled hypertension (>170/100 millimeter of mercury [mm Hg]) currently or within the past 7 days, or
Uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; subjects with known HTN should be stable within these ranges while under pharmaceutical therapy.
Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 150 mm Hg, or diastolic blood pressure > 95 mm Hg; those subjects with known HTN should be stable within these ranges while under pharmaceutical therapy
The participant has uncontrolled hypertension defined as systolic blood pressure greater than or equal to 180 millimeters of mercury (mm Hg) or diastolic blood pressure greater than or equal to 130 mm Hg.
The participant has uncontrolled hypertension defined as systolic blood pressure greater than or equal to 180 millimeters of mercury (mm Hg) or diastolic blood pressure greater than or equal to 130 mm Hg.
Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
Current uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management) as well as prior history of hypertensive crisis or hypertensive encephalopathy.
Patients with uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
Uncontrolled or poorly controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
Current uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management) as well as prior history of hypertensive crisis or hypertensive encephalopathy.
Hypertension not controlled by medical therapy (resting systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg on at least two occasions over a 24 hour period despite optimal medical management)
Evidence of poorly controlled hypertension which is defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management
Uncontrolled hypertension despite appropriate medical therapy (blood pressure of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening period). Note: Patients may be rescreened after adjustments of antihypertensive medications
Subject has uncontrolled hypertension, defined as a blood pressure reading >160/100 mmHg, despite maximum antihypertensive therapy.
Severe and uncontrolled Cushing syndrome despite medical management (e.g., systolic blood pressure > 160 mmHg or hyperglycemia with fasting glucose above 300 mg/dL).
Uncontrolled hypertension (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg on repeated measurement) despite optimal medical management
Clinically significant uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Uncontrolled hypertension (blood pressure >= 150/90 mmHg despite optimal medical management)
Uncontrolled arterial hypertension defined by blood pressure > 150 mmHg systolic and/or 100 mmHg diastolic at rest (average 3 consecutive readings at least 5 minutes apart) despite appropriate medical therapy
CERITINIB EXCLUSION CRITERIA: Cardiovascular disorders including:\r\n* Symptomatic congestive heart failure (New York Heart Association class III or IV)\r\n* Personal or family history of congenital long QT syndrome\r\n* Corrected QTc > 480 msec using Fridericia correction on screening electrocardiography (ECG)\r\n* Uncontrolled hypertension (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg on repeated measurement) despite optimal medical management
REGORAFENIB EXCLUSION CRITERIA: Cardiovascular disorders including:\r\n* Symptomatic congestive heart failure (New York Heart Association class III or IV)\r\n* Personal or family history of congenital long QT syndrome\r\n* Corrected QTc > 480 msec using Fridericia correction on screening electrocardiography (ECG)\r\n* Uncontrolled hypertension (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg on repeated measurement) despite optimal medical management
ENTRECTINIB EXCLUSION CRITERIA: Cardiovascular disorders including:\r\n* Symptomatic congestive heart failure (New York Heart Association class III or IV)\r\n* Personal or family history of congenital long QT syndrome\r\n* Corrected QTc > 480 msec using Fridericia correction on screening electrocardiography (ECG)\r\n* Uncontrolled hypertension (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg on repeated measurement) despite optimal medical management
The patient has uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
Uncontrolled hypertension despite appropriate medical therapy (blood pressure of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening period); Note: patients may be rescreened after adjustments of antihypertensive medications
Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
Subjects who have a history or current evidence of uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg at screening despite optimal medical management; subjects with a history of mild to moderate hypertension are eligible at the investigator’s discretion if the hypertension is adequately controlled by antihypertensive treatment used at a stable dose for at least 2 weeks before the start of study treatment
Uncontrolled hypertension, defined as systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Patients who have uncontrolled or poorly-controlled hypertension (> 139 mmHg systolic or > 89 mmHg diastolic for > 4 weeks) despite standard medical management
Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Uncontrolled arterial hypertension (systolic blood pressure > 155 mmHg or diastolic > 95 mmHg) despite appropriate medical therapy
Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Have uncontrolled hypertension, as defined in CTCAE Version 4.0, prior to initiating study treatment, despite antihypertensive intervention. CTCAE Version 4.0 defines uncontrolled hypertension as Grade >2 hypertension; clinically, the participant continues to experience elevated blood pressure (systolic >160 millimeters of mercury [mmHg] and/or diastolic >100 mmHg) despite medications.
Uncontrolled hypertension (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management
Uncontrolled hypertension – blood pressure >= 150/90 mmHg despite medical therapy
Subjects who have a history or current evidence of uncontrolled hypertension defined as systolic blood pressure ?160 mmHg or diastolic blood pressure ?100 mmHg at screening despite optimal medical management.
Uncontrolled hypertension; (systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg, despite optimal medical management.
Hypertension as defined by systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical management
Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Unstable hypertension defined as a systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management
Uncontrolled hypertension (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version [v]4.0) on repeated measurement) despite optimal medical management
Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
Uncontrolled hypertension (blood pressure ? 150/90 mmHg despite optimal medical management)
b. Uncontrolled hypertension (systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mmHg despite optimal medical management)
Systolic blood pressure > 160 mmHg or diastolic pressure > 90 mmHg despite optimal medical management
Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 85 mmHg despite optimal medical management
Uncontrolled hypertension defined as systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management
Have uncontrolled hypertension (systolic blood pressure [SBP] greater than140 mmHg or diastolic blood pressure [DBP] greater than 90 mmHg) despite optimal medical management.
Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg, despite optimal medical management
History of uncontrolled hypertension (systolic > 150 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management
Uncontrolled hypertension defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg, despite optimal medical management and stable antihypertensive treatment for more than 7 days before the first dose of study drug
Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg on 2 or more consecutive blood pressure readings, despite optimal medical management
Uncontrolled hypertension (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg on repeated measurement) despite optimal medical management
Uncontrolled hypertension (systolic blood pressure >150 millimeters of mercury [mmHg] or diastolic pressure >90 mmHg despite optimal medical management).
Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
Uncontrolled hypertension, defined below:\r\n* Patients < 18 years old:\r\n** Diastolic Blood Pressure Within The Upper Limit Of Normal Defined as: A diastolic blood pressure (DBP) > the 95th percentile for age and gender despite optimal medical management\r\n* Patients >= 18 years old\r\n** Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medial management
Uncontrolled hypertension (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg on repeated measurement) despite optimal medical management
Uncontrolled hypertension defined as systolic blood pressure ? 160 mmHg or diastolic blood pressure ? 100 mmHg, despite medical management
Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is defined as follows:\r\n* Patients aged =< 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height which is not controlled by one anti-hypertensive medication\r\n* Patients aged > 17 years: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg that is not controlled by one anti-hypertensive medication
Persistent uncontrolled hypertension (systolic >160 mmHg/ diastolic >100 mmHg Exclusion Criteria Part D
Patients’ baseline blood pressure must be adequately controlled with or without antihypertensive medications prior to enrollment (systolic < 140 mmHg, diastolic < 90 mmHg)
Inadequately controlled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg) despite antihypertensive medication
Inadequately controlled hypertension (defined as systolic blood pressure ? 200 mmHg and/or diastolic blood pressure ? 120 mmHg) on more than one occasion in the month before planned day of infusion
Systolic blood pressure > 160 mmHg or < 90 mmHg
Uncontrolled hypertension (diastolic blood pressure > 100 mmHg; systolic blood pressure > 150 mmHg)
Patients’ baseline blood pressure must be adequately controlled with or without antihypertensive medications prior to enrollment (systolic =< 140 mmHg, diastolic =< 90 mmHg)
Uncontrolled hypertension defined as persistent systolic blood pressure ? 150 mmHg or diastolic blood pressure ? 100 mmHg despite current therapy.
Uncontrolled hypertension (systolic blood pressure ? 160 mmHg or diastolic blood pressure ? 95 mmHg)
Uncontrolled glaucoma with intraocular pressure ? 21 mmHg
Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and /or diastolic blood pressure > 100 mmHg)
Subject has blood pressure controlled to < 150 mmHg systolic and < 95 mmHg diastolic at screening
Inadequately controlled hypertension (defined as systolic blood pressure >= 150 mmHg and /or diastolic blood pressure >= 100 mmHg) within 7 days of first study treatment
Uncontrolled high blood pressure (i.e. systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg)
The patient has uncontrolled or poorly controlled hypertension (> 180 mmHg systolic or > 130 mmHg diastolic) at the time of enrollment
Poorly controlled diabetes mellitus or hypertension (e.g., systolic > 180 mmHg or diastolic > 100 mmHg)
(Bevacizumab-related exclusion) Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)
Systolic blood pressure (SBP) >160 mmHg or <90 mmHg at screening.
Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
Supine systolic blood pressure < 90 millimeter of mercury (mmHg), or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of > 20 mmHg despite medical management (eg, midodrine, fludrocortisones) in the absence of volume depletion
As determined by the treating investigator, the patient must have well-controlled blood pressure, defined as systolic blood pressure < 150 mmHg and/or diastolic blood pressure < 100 mmHg for the majority of measurements
Patients who have uncontrolled hypertension (defined as sustained systolic blood pressure >= 160 mmHg or diastolic >= 100 mmHg)
Patients with chronic hypertension that is well controlled with systolic blood pressure of < 140 mmHg or diastolic blood pressure of < 90 mmHg, and in whom there has been no change in blood pressure medication in the last two weeks, are eligible
Patients with uncontrolled hypertension (defined as sustained systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg)
As determined by the treating investigator, the patient must have well-controlled blood pressure, defined as systolic blood pressure < 150 mmHg and/or diastolic blood pressure < 100 mmHg for the majority of measurements
Uncontrolled hypertension (defined as a sustained systolic pressure >= 160 mmHg and/or a diastolic pressure >= 110 mmHg
Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg); anti-hypertensive therapy to achieve these parameters is allowable
Patients with a cumulative lifetime history of anthracycline greater than 430 mg/m^2 are eligible, after consultation with a cardiologist, if there are none of the following cardiac risk factors:\r\n*Diabetes mellitus\r\n*History of acute coronary syndrome\r\n*Hypertension; defined as a sustained systolic blood pressure greater than 140 mmHg and/or diastolic blood pressure greater than 90 mmHg OR use of an antihypertensive medication for the indication of hypertension
Uncontrolled hypertension, defined as: systolic blood pressure ? 140 mmHg and/or diastolic blood pressure ? 90 mmHg;
Hypertension not controlled by medical therapy (systolic blood pressure greater than 140 millimeter of mercury [mmHg] or diastolic blood pressure greater than 90 mmHg)
Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 90 mmHg or systolic blood pressure > 140 mmHg; subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
Patients who have uncontrolled hypertension (defined as sustained systolic blood pressure >= 160 mmHg or diastolic >= 100 mmHg)
Patients who have uncontrolled hypertension (systolic > 140 mmHg and/or diastolic > 90 mmHg); it is permissible to start treatment for hypertension prior to randomization
History of uncontrolled hypertension, defined as blood pressure > 150/95 mmHg, or systolic blood pressure > 180 mmHg when diastolic blood pressure < 90 mmHg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment
Inadequately controlled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
Systolic blood pressure greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg
Inadequately controlled hypertension (blood pressure: systolic > 150 mmHg and/or diastolic > 100 mmHg)
Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication)
Uncontrolled hypertension as indicated by at least 2 consecutive measurements of a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening Visit
Inadequately controlled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg); to control hypertension, the addition or increase of standard of care antihypertensive regimen is allowed
Inadequately controlled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg) despite antihypertensive medication, or prior history of hypertensive crisis or hypertensive encephalopathy
Inadequately controlled hypertension (defined as systolic blood pressure > 140 and/or diastolic blood pressure > 90 mmHg); initiation of antihypertensive is permitted provided adequate control is documented over at least 1 week prior to day 1 of study drug
Supine systolic blood pressure < 100 mmHg or supine diastolic blood pressure < 50 mmHg at screening and baseline
Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 95 mmHg)
Uncontrolled hypertension on anti-hypertensive medication (systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg)
Blood pressure < 160/100 mmHg
Inadequately controlled hypertension (systolic blood pressure of > 150 mmHg or diastolic pressure > 90 mmHg on anti-hypertensive medications)
Uncontrolled arterial hypertension defined as persistent elevation of systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg despite medical treatment
Patients with hypertension on medical management must have systolic blood pressure < 150 mmHG or diastolic pressure < 90 mmHG at study entry
Uncontrolled hypertension (defined as a systolic pressure ? 160 mmHg and/or a diastolic pressure ? 110 mmHg).
Hypertension not controlled by medical therapy (systolic blood pressure [BP] greater than 160 millimeters of mercury [mmHg] or diastolic blood pressure great than 100 mmHg)
Inadequately controlled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg)
Systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg
Uncontrolled high blood pressure (i.e., systolic blood pressure >= 160 mmHg, diastolic blood pressure >= 90 mmHg)
Hemodynamic parameters:\r\n* Systolic blood pressure < 140 mmHg\r\n* Diastolic blood pressure < 90 mmHg
For patients receiving antihypertensive medication:systolic blood pressure < 120 mmHg\n             and/or diastolic blood pressure < 70 mmHg at screening.
Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
Patients must have blood pressure measured within 14 days prior to registration; patients must not have uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart) despite appropriate medical therapy; Note: patients may be rescreened after adjustments of antihypertensive medications
Uncontrolled hypertension with systolic blood pressure >160 mmHg
For Cohort C: Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
Patient must have a systolic blood pressure =< 140 mmHg and diastolic blood pressure must be =< 90 mmHg, measured within 4 weeks prior to randomization; initiation or adjustment of anti-hypertensives prior to starting study treatment is allowed
Patients are ineligible if they have inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
Uncontrolled blood pressure (systolic pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg on repeated measurements).
Subjects with a blood pressure of >140/90 mmHg.
Uncontrolled hypertension (defined as a systolic pressure ? 160 mmHg and/or a diastolic pressure ? 110 mmHg).
Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg); anti-hypertensive therapy to maintain a systolic blood pressure < 150 mmHg and/or diastolic blood pressure < 100 mmHg is permitted
Treatment refractory hypertension defined as a blood pressure of systolic >140 millimeter of mercury (mmHg) and/or diastolic >90 mmHg which cannot be controlled by antihypertensive therapy.
Patients with pre-existing hypertension should be on a stable antihypertensive regimen and have a blood pressure =< 150/100 mmHg at the time of enrollment
Uncontrolled arterial hypertension defined as persistent elevation of systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg despite current therapy
Inadequately controlled hypertension (defined as average systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
Hypotension as indicated by systolic blood pressure < 86 mmHg on 2 consecutive measurements at the Screening visit.
Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg on 2 consecutive measurements at the Screening visit.
Patients who have uncontrolled hypertension (defined as sustained systolic blood pressure >= 160 mmHg or diastolic >= 100 mmHg)
Systolic blood pressure greater than 160 mmHg or less than 90 mmHg at screening
Uncontrolled hypertension (blood pressure >160 mmHg systolic and >100 mmHg diastolic).
Controlled blood pressure defined as a systolic blood pressure =< 140 mmHg and diastolic blood pressure =< 90 mmHg on no more than three anti-hypertensive agents; drug formulations containing two or more anti-hypertensive agents will be counted based on the number of active agents in each formulation
Patients with uncontrolled hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
Patients with poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher) are ineligible; patients with a history of hypertension (HTN) and stable blood pressure (BP) < 140/90 on anti-HTN regimen are eligible
Inadequately controlled hypertension (i.e., systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) (patients with values above these levels must have their blood pressure controlled with medication prior to starting treatment).
Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication)
Significant active cardiovascular disease including:\r\n* Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg)\r\n* Grade 3 or higher valvular disease\r\n* Grade 3 or higher atrial fibrillation\r\n* Grade 3 or higher bradycardia\r\n* Endocarditis\r\n* Pulmonary embolism\r\n* Recent cerebrovascular accident within 6 months prior to enrollment
Diastolic blood pressure above the 95% for age in children and > 160 mmHg systolic or > 100 mmHg diastolic in adults on at least 2 of 3 measurements with an appropriate-size cuff who are unable to achieve blood pressure control with optimal anti-hypertensive therapy; patients who are treated with antihypertensive medications with good response are eligible
Known impaired cardiac function or clinically significant cardiac disease such as ventricular arrhythmia requiring therapy, congestive heart failure and uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
Subject has uncontrolled hypertension as indicated by a resting systolic blood pressure > 160 millimeter of mercury (mmHg) or diastolic blood pressure > 100 millimeter of mercury (mmHg) at Screening.
Patients must have controlled blood pressure with a systolic blood pressure < 140 mmHg and diastolic < 90 mmHg; anti-hypertensive medications are permitted
Blood pressure well controlled and must have systolic < 140 mmHg and diastolic < 90 mmHg
Systolic blood pressure >160 or <90 mmHg
Patients with inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg) are not eligible for participation
Poorly controlled hypertension, defined as systolic blood pressure >= 150 mmHg or diastolic blood pressure of >= 95 mmHg
Patient must not have poorly controlled hypertension (defined as systolic blood pressure of >= 140 mmHg or diastolic blood pressure of >= 90 mmHg); initiation or adjustment of antihypertensive medications is permitted prior to study entry; blood pressure must be re-assessed on two occasions that are separated by a minimum of one hour; on each of these occasions, the mean (of 3 readings) from each assessment must be < 140/90 mmHg for a patient to be eligible for this study
Generally well-controlled blood pressure with systolic blood pressure =< 140 mmHg AND diastolic blood pressure =< 90 mmHg prior to enrollment; the use of anti-hypertensive medications to control hypertension is permitted
Vital signs within the ranges: systolic blood pressure 80-150 mmHg , diastolic blood pressure 50-100 mmHg, pulse rate 40-100 bpm, oral body temperature 35.0-37.5°C.
Patients with poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 91 mmHg or higher) are ineligible
History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by anti-hypertensive therapy)
Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
Patients’ baseline blood pressure must be adequately controlled with or without antihypertensive medications prior to enrollment (systolic < 145 mmHg, diastolic < 90 mmHg)
Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication)
Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication)
Controlled blood pressure (defined as systolic BP </= 140 mmHg and diastolic </= 85 mmHg)
Systolic blood pressure 80-180 mmHg
Significant uncontrolled pulmonary hypertension defined as: Pulmonary artery peak systolic pressure > 55 mmHg by echocardiogram, or pulmonary artery peak systolic pressure 45-55 mmHg by echocardiogram and mean pulmonary artery pressure by right heart catheterization exceeding 25 mmHg at rest (or 30 mmHg with exercise); or NYHA/World Health Organization (WHO), Class III or IV
Seated systolic blood pressure 90 to 180 mmHg
Uncontrolled hypertension defined as systolic blood pressure ?160 mmHg and/or diastolic blood pressure ?100 mmHg confirmed upon repeated measures
Uncontrolled hypertension defined as systolic blood pressure ? 160 mmHg and/or diastolic blood pressure ? 100 mmHg confirmed upon repeated measures
Uncontrolled hypertension as indicated by at least 2 consecutive measurements of a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit.
Supine systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg.
Patients must have blood pressure no greater than 140 mmHg (systolic blood pressure) and 90 mmHg (diastolic blood pressure) for eligibility; initiation or adjustment of antihypertensive medications is permitted prior to study entry provided that the average of three blood pressure measurements at enrollment visit is less than 140/90 mmHg
Blood pressure ? 140/90 mmHg.
Inadequately controlled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg)
Hypotension at the time of screening (i.e., systolic blood pressure less than 110 mmHg. Diastolic blood pressure less than 60 mmHg)
Confirmed systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg
Intraocular pressure > 21 mmHg as measured by tonometry
6. Uncontrolled hypertension (diastolic ? 100 mmHg) or hypotension (systolic ? 90 mmHg).
Subjects with uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg) are excluded. Subjects requiring 2 or more medications to control hypertension are eligible with Medical Monitor approval.
Uncontrolled high blood pressure (that is, systolic blood pressure >180 millimeter of mercury [mmHg], diastolic blood pressure >95 mmHg).
History of uncontrolled hypertension, defined as systolic blood pressure > 150 mmHg while simultaneous diastolic blood pressure > 100 mmHg, or systolic blood pressure > 180 mmHg when diastolic blood pressure < 90 mmHg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment
Uncontrolled hypertension: systolic blood pressure of > 140 mmHg or diastolic blood pressure of > 90 mmHg documented on 2 consecutive measurements taken at least 24 hours apart
Uncontrolled hypertension (diastolic greater to or equal to 100 mmHg) or hypotension (systolic less than or equal to 90 mmHg)
Treatment refractory hypertension defined as systolic blood pressure >140 millimetres of mercury (mmHg) and/or diastolic blood pressure >90 mmHg which cannot be controlled by antihypertensive therapy
Uncontrolled hypertension as indicated by a resting systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg
Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); or history of congestive heart failure (equal to or greater than Grade 2).
Poorly controlled hypertension (defined as systolic blood pressure of>=150 millimeter of mercury (mmHg) or diastolic blood pressure of >100 mmHg based on a mean of three measurements at approximately 2-minute intervals)
Inadequately controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg despite antihypertensive medication)
Generally well-controlled blood pressure with systolic blood pressure =< 140 mmHg AND diastolic blood pressure =< 90 mmHg prior to enrollment; the use of antihypertensive medications to control hypertension is permitted
Inadequately controlled hypertension (systolic blood pressure of > 150 mmHg or diastolic pressure > 100 mmHg on anti-hypertensive medications)
Uncontrolled hypertension: systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 24 hours apart.
Poorly controlled hypertension [defined as systolic blood pressure of > or = 140 mmHg or diastolic blood pressure of > or = 90 mmHg].
Systolic blood pressure <90 mmHg.
Uncontrolled hypertension, defined as systolic blood pressure >= 150 mmHg or a diastolic pressure >= 100 mmHg (the use of antihypertensive medications to achieve these goals is allowed)
Poorly controlled systemic vascular hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
Uncontrolled hypertension with systolic blood pressure >160 mmHg
Patients who have uncontrolled hypertension (defined as sustained systolic blood pressure >= 160 mmHg or diastolic >= 100 mmHg)
No uncontrolled hypertension (systolic blood pressure =< 160 millimeters of mercury [mmHg] or diastolic =< 100 mmHg); patients with hypertension must be adequately controlled with appropriate anti-hypertensive therapy or diet
Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg); anti-hypertensive therapy to achieve these parameters is allowed
Severe untreated resting arterial hypertension (> 200 mmHg systolic, > 120 mmHg diastolic) at the time of enrollment
Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg at the time of study enrollment
Sitting systolic blood pressure > 90 mmHg
Systolic blood pressure ?180 mmHg or diastolic blood pressure ?110 mmHg;
Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg at the time of study enrollment
Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg at the time of study enrollment
Uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg)
Low resting systolic blood pressure: < 90 mmHg
Uncontrolled arterial hypertension (systolic blood pressure > 200 mmHg, diastolic > 110 mmHg)
Uncontrolled or poorly controlled hypertension, defined as systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, whether or not the subject is receiving anti-hypertensive treatment; subjects may be rescreened if the blood pressure is successfully and promptly controlled within 5 days using conventional anti-hypertensive therapy to achieve optimal blood pressure control (< 140/90 mmHg)
Uncontrolled severe hypertension (systolic > 200mmHg or diastolic > 120 mmHg)
Patients who are hypotensive with a systolic blood pressure reading of < 110 mmHg at any time over the 3 days prior to study entry
Poorly controlled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 1000 mmHg), with or without antihypertensives
Have uncontrolled hypertension and resting blood pressure exceeding 140/80 mmHg
Uncontrolled hypertension (mmHg > 160 systolic or > 90 diastolic)
Blood pressure between 90 and 150 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic.
Intraocular pressure > 21 mmHg as measured by tonometry
Patients with uncontrolled seizures
Patients with uncontrolled seizures
Patients with uncontrolled seizures are not eligible for the study
Subjects with uncontrolled seizures
Subjects with a known history of uncontrolled seizures
Subjects with uncontrolled seizures.
Patients with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures.
Patients should not have a history of uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures.
Uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Patients with uncontrolled seizures.
Patients with uncontrolled seizures.
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Patients with uncontrolled seizures
Patients with uncontrolled seizures
No history of uncontrolled seizures
Subjects with uncontrolled seizures
Subjects with uncontrolled seizures
Uncontrolled seizures or uncontrolled hypertension
Evidence of uncontrolled brain metastases or history of uncontrolled seizures.
Uncontrolled seizures
Uncontrolled seizures
Subjects with clinically significant increased intracranial pressure or uncontrolled seizures.
Patients with uncontrolled seizures
Patients with a history of uncontrolled seizures
Uncontrolled systemic disease(s) such as hypertension or diabetes mellitus; blood pressure must be =< the 95th percentile for age, height, and gender
A blood pressure (BP) =< the 95th percentile for age, height, and gender for pediatric patients < 18 years old and =< 140/90 mmHg for patients >= 18 years old; patients should not be receiving medication for treatment of hypertension (except patients with Wilms tumor and RCC who may be eligible if on stable doses of no more than one anti-hypertensive medication with a baseline BP =< ULN for pediatric patients and =< 140/90 for adult patients); please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP
A blood pressure (BP) =< 95% percentile for age, height, and gender; patients on stable doses of no more than one anti-hypertensive medication, with a baseline BP =< 95% percentile for age, height, and gender will be eligible
Adequate Blood Pressure Control defined as a blood pressure (BP) <= the 95th percentile for age, height, and gender measured, subjects on stable doses of no more than one anti-hypertensive medication, with a baseline BP <= 95th percentile for age, height and gender, will be eligible.
A blood pressure (BP) =< the 95th percentile for age, height, and gender, and not receiving medication for treatment of hypertension; please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP
Hypertension:\r\n* Patients, 3-17 years of age must have a blood pressure that is =< 95th percentile for age, height and gender at the time of registration\r\n** The normal blood pressure by height, age and gender tables can be accessed in the Generic Forms section of the Pediatric Brain Tumor Consortium (PBTC) members’ webpage\r\n* Patients who are >= 18 years of age must have a blood pressure that is < 140/90 mm of Hg at the time of registration\r\n* Note: if a blood pressure (BP) reading prior to registration is above the 95th percentile for age, height and gender it must be rechecked and documented to be =< the 95th percentile for age, height and gender prior to patient registration
Blood pressure (BP) =< 95th percentile for age, height, and gender and not receiving medication for treatment of hypertension
A blood pressure (BP) =< the 95th percentile for age, height and gender despite optimal antihypertensive treatment within 7 days of the first dose of the study treatment; please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP
Concurrent uncontrolled hypertension defined as sustained blood pressure > 95th percentile for age, height and gender (systolic or diastolic) despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
A blood pressure (BP) =< the 95th percentile for age, height, and gender and not receiving medication for treatment of hypertension
A blood pressure (BP) =< the 95th percentile for age, height, and gender measured within 7 days prior to enrollment; please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP; patients with hypertension controlled on antihypertensive medications will be allowed if otherwise eligible
A blood pressure (BP) =< the 95th percentile for age, height, and gender measured, and not receiving medication for treatment of hypertension; please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP
Hypertension must be well controlled (=< 95th percentile for age and height if patient is =< 17 years) on stable doses of medication
Patients 2-17 years of age must have a blood pressure that is ? 95th percentile for age, height and gender at the time of enrollment.
Note: If a BP reading prior to enrollment is above the 95th percentile for age, height and gender, it is to be rechecked and documented to be ? 95th percentile for age, height and gender prior to patient enrollment.
Patients with inadequately controlled systemic hypertension (systolic blood pressure [SBP] and/or\r\ndiastolic blood pressure [DBP] > 95th percentile for age and height)\r\n* Patients with a prior history of hypertensive crisis and/or hypertensive encephalopathy\r\nIf a blood pressure (BP) measurement prior to registration is > 95th percentile for age and height, it must be rechecked and documented to be < 95th percentile for age and height prior to registration; if a patient falls between the height or weight percentiles, site should average the value as appropriate; for patients >= 18 years, use adult normal ranges for blood pressure; patients with hypertension are eligible if their blood pressures become < 95th percentile after anti-hypertensive medications
Participants should have normal blood pressure according to age; participants 18 years of age and younger should have a blood pressure =< 95th percentile for age, height and gender, and should not be receiving medication for treatment of hypertension; preexisting hypertension in adults should be controlled (either with pharmacological or non-pharmacological methods) at the time of enrollment
BMI ? 85th percentile or waist circumference ? 85th percentile for age and gender
Patient must have blood pressure ? 95th percentile for age, height, and gender
Adequate Blood Pressure Control defined as: Blood pressure <= the 95th percentile for age, height, and gender.
Adequate blood pressure defined as:\r\n* A blood pressure (BP) =< the 95th percentile for age, height, and gender measured; adequate blood pressure can be achieved using medication for treatment of hypertension
BMI >= 50th percentile at time of study enrollment
Hypertensive patients are eligible provided the hypertension is well controlled (95th percentile for age and height if patient =< 17 years) on stable doses of medication
The patient has uncontrolled or poorly controlled hypertension despite standard medical management as defined in this protocol
Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy.
Uncontrolled hypertension (as defined as ? 160/90 despite optimal medical management)
Uncontrolled arterial hypertension >/= 150/ >/= 90 millimeter of mercury (mmHg) despite standard medical management;
Patients with uncontrolled arterial hypertension despite optimal medical management or uncontrolled type I or II diabetes mellitus; patients with well-controlled arterial hypertension or diabetes mellitus are eligible
Uncontrolled hypertension despite optimal medical management
Uncontrolled hypertension (despite medical therapy); blood pressure should be < 140/90 in accordance with American Heart Association definition of hypertension
Poorly controlled hypertension, defined as sustained, uncontrolled, non-episodic baseline hypertension consistently above 159/99 mmHg despite optimal medical management
Sustained uncontrolled hypertension (> 150/90 average over 1 week) despite optimal medical management
FOR ALL PHASES (Ib AND II): Uncontrolled arterial hypertension despite optimal medical management
The patient has uncontrolled or poorly-controlled hypertension (>= 150 / >= 90 mm Hg) despite standard medical management
Uncontrolled hypertension despite optimal medical management (per investigator´s assessment)
Poorly controlled hypertension despite multiple antihypertensive medication or
Uncontrolled arterial hypertension despite appropriate medical therapy
Patient with poorly controlled hypertension despite multiple antihypertensives
Uncontrolled arterial hypertension despite optimal medical management (per institutional guidelines).
Uncontrolled arterial hypertension despite appropriate medical therapy
Uncontrolled hypertension (HTN) despite medical management (blood pressure [BP] >= 160/100)
The participant has uncontrolled hypertension, despite antihypertensive intervention.
Uncontrolled hypertension (> 150/100 mmHg despite optimal medical therapy)
Have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention.
Uncontrolled hypertension (> 160/100 mm Hg despite optimal medical therapy)
Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment).
Uncontrolled arterial hypertension despite medical treatment
Uncontrolled arterial hypertension despite medical treatment
The participant has uncontrolled arterial hypertension ?150 / ?90 millimeters of mercury (mm Hg) despite standard medical management
Patients with poorly controlled hypertension despite multiple antihypertensive medications
Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment) (modified by amendment 1)
Uncontrolled arterial hypertension despite medical treatment
Uncontrolled hypertension despite optimal medical management
Uncontrolled arterial hypertension despite appropriate medical therapy
Patients with uncontrolled intracranial hypertension syndrome (defined as: persistence of headache, transient visual obscurations, and/or diplopia despite optimal clinical management) or uncontrolled seizure activity (i.e. recorded despite optimal medical management)
Uncontrolled Hepatitis B despite appropriate therapy.
Uncontrolled arterial hypertension despite medical treatment
Uncontrolled hypertension defined as optimally treated baseline blood pressure that exceeds 140/90 mm Hg despite optimal medical management
Patients with uncontrolled hypertension (systolic > 140, diastolic > 90) despite antihypertensive therapy
Uncontrolled arterial hypertension despite medical treatment
Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy
No cardiovascular disorders including:\r\n* Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening\r\n* Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic, or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days prior to registration\r\n* Any of the following within 6 months prior to registration:\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
Significant cardiovascular or cerebrovascular disease including:\r\n* Uncontrolled hypertension (systolic blood pressure [SBP] >= 150; diastolic blood pressure [DBP] >= 90)\r\n* History of myocardial infarction within 6 months\r\n* Unstable angina\r\n* New York Heart Association functional classification II, III or IV\r\n* Baseline ejection fraction =< 50% as assessed by echocardiogram or multi-gated acquisition (MUGA)\r\n* Cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months\r\n* Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or peripheral arterial thrombosis) within 6 months
Known cardiopulmonary disease defined as having one or more of the following:\r\n* Uncontrolled high blood pressure (i.e. systolic > 180 mmHg or diastolic > 95 mmHg);\r\n* Cardiomyopathy\r\n* Ischemic heart disease; patients with acute coronary syndrome, myocardial infarction, and/or revascularization (e.g. coronary artery bypass graft, stent) within 6 months of first dose of study drug are excluded; patients with a history of ischemic heart disease who have had revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll\r\n* Arrhythmia (e.g. history of polymorphic ventricular fibrillation or torsade de pointes); patients with symptomatic atrial fibrillation (Afib) incompletely controlled medically, or controlled by device (e.g. pacemaker) or by ablation are excluded; however, patients with stable, asymptomatic AFib for a period of at least 6 months, whose Afib is controlled with medication, or who have a history of paroxysmal AFib are permitted to enroll\r\n* Implantable cardioverter defibrillator\r\n* Congestive heart failure (New York Heart Association [NYHA] class III or IV; or class II with a recent decompensation requiring hospitalization or referral to a heart failure clinic within 4 weeks before screening)\r\n* Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing); mild regurgitation is not excluded\r\n* Pulmonary hypertension
Clinically significant cardiovascular disease including:\r\n* Myocardial infarction or uncontrolled angina within 6 months\r\n* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past\r\n* Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit
Patients with clinically significant cardiovascular disease including: uncontrolled hypertension defined as systolic > 150 mm Hg or diastolic > 90 mm Hg; unstable angina or who have had a myocardial infarction within the past six months prior to registration; New York Heart Association (NYHA) grade II or greater congestive heart failure; serious cardiac arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate); or CTCAE v4.0, grade 2 or greater peripheral vascular disease (peripheral ischemia), defined as having at least brief (< 24 hour) episodes of ischemia managed non-surgically and without permanent deficit
Heart disease including congestive heart failure (New York Heart Association [NYHA] grade II or greater); unstable angina; prior myocardial infarction (non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]) within 6 months prior to study enrollment; hypertension with a systolic blood pressure of > 150 mm Hg or diastolic blood pressure of >100 mm Hg while on antihypertensive medication
Current symptomatic congestive heart failure (New York Heart Association classification >= grade III), unstable cardiac arrhythmia requiring therapy (e.g. medication or pacemaker), unstable angina (e.g. new, worsening or persistent chest discomfort), or uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg); or any of the following occurring within 6 months (180 days) prior to first dose of study treatment: myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack; use of antihypertensive medication to control blood pressure is allowed
Clinically significant, uncontrolled heart diseases\r\n* Unstable angina within 6 months prior to screening\r\n* Myocardial infarction within 6 months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without antihypertensive medication; initiation or adjustment of antihypertensive medication (s) is allowed prior to screening\r\n* Ventricular arrhythmias\r\n* Supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Fridericia's correction formula (QTcF) > 480 msec
Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* History or presence of serious uncontrolled ventricular arrhythmias\r\n* Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE)\r\n* Uncontrolled hypertension (defined as systolic blood pressure [SBP] >= 160 mm Hg or diastolic blood pressure [DBP] >= 100 mm Hg while on anti-hypertensive medications)
Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: \r\n* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n** History or presence of serious uncontrolled ventricular arrhythmias\r\n** Clinically significant resting bradycardia\r\n** Left ventricular ejection fraction (LVEF) assessed by 2-dimensional (2-D) echocardiogram (ECHO) < 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan (MUGA), < 45% or lower limit of normal (whichever is higher)\r\n** Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE)\r\n** Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication(s)\r\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) \r\n* Cirrhosis, chronic active hepatitis or chronic persistent hepatitis \r\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)\r\n* Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin; full-dose anti-coagulation with low molecular weight heparin is permitted\r\n* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
Current symptomatic congestive heart failure (New York Heart Association > class II), unstable cardiac arrhythmia requiring therapy (e.g. medication or pacemaker), unstable angina (e.g. new, worsening or persistent chest discomfort), or uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100mmHg). Or any of the following occurring within 6 months (180 days) prior to first dose of study drugs: myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack. (Use of antihypertensive medication to control blood pressure is allowed.)
Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:\r\n* Any medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone once daily\r\n* History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents\r\n* Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment (systolic BP <160 mmHg or diastolic BP <95 mmHg)\r\n* Active or symptomatic viral hepatitis or chronic liver disease\r\n* Known active human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. (HIV testing is not mandatory)\r\n* History of pituitary or adrenal dysfunction\r\n* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class III or IV heart disease or cardiac ejection fraction measurement of < 50% at baseline, or clinically significant ventricular arrhythmias within 6 months prior to treatment start.\r\n* History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness =< 1 year prior to treatment start; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)\r\n* Uncontrolled diabetes mellitus\r\n* History of inflammatory bowel disease\r\n* Baseline moderate and severe hepatic impairment (Child Pugh class B & C)
Significant medical history or unstable medical comorbidities, including but not limited to:\r\n* Heart disease including congestive heart failure (New York Heart Association [NYHA] grade II or greater); unstable angina; prior myocardial infarction (non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]) within 6 months prior to study enrollment; hypertension with a systolic blood pressure of > 150 mm Hg or diastolic blood pressure of > 100 mm Hg while on antihypertensive medication\r\n* Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block\r\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval\r\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\r\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses\r\n* Active infection or ongoing antiviral medication for viral infections including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Screening for chronic conditions is not required. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with osimertinib\r\n* Ongoing use of warfarin (injectable low-molecular weight heparins are permitted). Patients must be off warfarin for > 7 days prior to enrollment
Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled Grade ?3 hypertension (diastolic blood pressure ?100 mmHg or systolic blood pressure ?160 mmHg) despite antihypertensive therapy.
Clinically significant cardiovascular disease including: \r\n* Myocardial infarction within 6 months \r\n* Uncontrolled angina within 6 months\r\n* Congestive heart failure New York Heart Association (NYHA) class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within three months results in a left ventricular ejection fraction that is >= 45%\r\n* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)\r\n* Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on the screening electrocardiogram (ECG) > 470 msec\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Hypotension (systolic blood pressure < 86 millimeters of mercury or bradycardia with a heart rate of < 50 beats per minute on any ECG taken at the screening visit\r\n* Bradycardia with a heat rate of < 50 beats per minutes in the screening ECG, unless pharmaceutically induced and reversible\r\n* Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit
Known cardiopulmonary disease defined as one of the following:\r\n* Uncontrolled high blood pressure (ie, systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Cardiomyopathy or history of ischemic heart disease\r\n* Arrhythmia (eg, history of polymorphic ventricular fibrillation or torsade de pointes); however, patients with < grade 3 atrial fibrillation (a fib) for a period of at least 6 months may enroll; grade 3 a fib is symptomatic and\r\nincompletely controlled medically, or controlled with device (e.g., pacemaker), or ablation; patients with paroxysmal a fib are permitted to enroll\r\n* Implantable cardioverter defibrillator\r\n* Congestive heart failure (New York Heart Association [NYHA] class III or IV; or class II with a recent decompensation requiring hospitalization or referral to a heart failure clinic within 4 weeks before screening), myocardial infarction and/or revascularization (eg, coronary artery bypass graft, stent) within 6 months of first dose of study drug\r\n* Patients who had ischemic heart disease who have had acute coronary syndrome (ACS), myocardial infarction (MI), and/or revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll\r\n* Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing)\r\n* Pulmonary hypertension
Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (< 6 months prior to the first planned dose of study drugs), myocardial infarction (< 6 months prior to the first planned dose of study drugs), unstable angina, congestive heart failure (New York Heart Association Classification class >= II), serious cardiac arrhythmia, or uncontrolled hypertension (systolic blood pressure [SBP] > 170/ diastolic blood pressure [DBP] > 105)
Participants may not have uncontrolled inter-current illness; this includes, but is not limited to: ongoing or active infection; symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV); unstable angina pectoris or new onset angina that began within the last 3 months; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy; or thrombotic/embolic events such as cerebrovascular accident, including transient ischemic attacks within the past 6 months; uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management; known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C; known grade 3 or 4 neurotoxicity
Patients with clinically significant, uncontrolled cardiovascular disease, such as:\r\n* Unstable angina within 6 months prior to screening\r\n* Myocardial infarction within 6 months prior to screening\r\n* Patients with a history of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Peripheral vascular disease\r\n* Patients with uncontrolled hypertension defined as a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication; initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias\r\n* Supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Patients with corrected QT (QTc) >= 450 ms (male patients) or >= 460 ms (female patients) using Fridericia correction (QTcF) on the screening electrocardiogram (ECG)\r\n* Patients with history of congenital long QT syndrome or history of torsade de pointes
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, uncontrolled hypertension (defined as an average systolic blood pressure [SBP] over 140 or a diastolic blood pressure [DBP] over 90 despite antihypertensive agents), clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, or severe orthostatic hypotension or clinically important autonomic disease; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant; NOTE: there is no lower limit of left ventricular ejection fraction below which patients are excluded from participation
History of serious systemic disease, including myocardial infarction or unstable angina within the last 12 months, history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension (blood pressure of > 140/90 mmHg) at the time of enrollment, New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease
Cardiac conditions as follows: uncontrolled hypertension (resting blood pressure [BP] ?150/95 millimeters of mercury [mmHg] despite optimal therapy), heart failure New York Heart Association (NYHA) Class II or above, prior or current cardiomyopathy, atrial fibrillation with heart rate >100 beats per minute (bpm). Unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment, or angina requiring use of nitrates more than once weekly)
Have significant, uncontrolled or active cardiovascular disease, specifically including but restricted to:\r\n* Myocardial infarction (MI) within 6 months of trial enrollment\r\n* Unstable angina within 6 months of trial enrollment\r\n* Congestive heart failure (CHF) with 6 months prior to trial enrollment\r\n* Any history of ventricular arrhythmia\r\n* Cerebrovascular accident or transient ischemic attack within 6 months of D1 of treatment\r\n* Clinically significant atrial arrhythmia or severe baseline bradycardia defined as resting heart rate < 50 beat per minute\r\n* Uncontrolled hypertension defined as baseline systolic blood pressure (SBP) > 160 and diastolic blood pressure (DBP) > 100 on 3 separate clinic visits or past history of hypertensive urgency, emergency or encephalopathy
Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:\r\n* Unstable angina within 6 months prior to screening?\r\n* Myocardial infarction within 6 months prior to screening?\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV);\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without antihypertensive medication.\r\n* Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening?\r\n* Ventricular arrhythmias\r\n* Supraventricular and nodal arrhythmias not controlled with medication?\r\n* Other cardiac arrhythmia not controlled with medication?\r\n* Corrected QT (QTcF) > 470 ms using Fridericia’s correction on the screening electrocardiography (ECG)
Any other serious illness or medical condition or social circumstance that might interfere with the subject’s participation in the trial or interfere with the interpretation of the results, including, but not limited to:\r\n* Any uncontrolled infection\r\n* New York Heart Association (NYHA) class III or class IV heart failure \r\n* Unstable angina\r\n* Myocardial infarction within the 6 months prior to study entry\r\n* Uncontrolled hypertension (systolic blood pressure [BP] > 160 mmHg despite 2 antihypertensive medications) \r\n* Chronic obstructive pulmonary disease (COPD) requiring hospital admission in the year prior to study entry\r\n* Diabetes mellitus requiring hospital admission in the year prior to study entry \r\n* Chronic liver disease\r\n* Hypothyroidism (thyroid-stimulating hormone [TSH] level > 3.0 mIU/L)\r\n* Substance abuse
No clinically significant cardiovascular disease including:\r\n* Myocardial infarction (MI) within 6 months\r\n* Uncontrolled angina within 3 months\r\n* Chronic heart failure (CHF) with New York Heart Association (NYHA) class 3 or 4, or patients with NYHA class 3 or 4 in the past, unless a screening echo or multigated acquisition scan (MUGA) performed within three months demonstrates an ejection fraction (EF) > 45% \r\n* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de pointes)\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Hypotension (systolic blood pressure [BP] < 86 mmHg) or bradycardia (< 50 beat per minute [bpm]) at screening\r\n* Uncontrolled hypertension (systolic BP >170 mmHg or diastolic BP >105 mmHg at screening)
Patients with significant cardiac history including:\r\n* Severe or unstable angina pectoris\r\n* Uncontrolled hypertension (defined as systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg;. Note - patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment\r\n* Atrial fibrillation or other cardiac arrhythmia requiring therapy.\r\n* Heart disease as evidenced by myocardial infarction, or aterial thrombotic events in the past 6 months\r\n* Class II-IV heart failure (as defined by New York Heart Association) or a cardiac ejection fraction measurement of less than 50% at baseline
Known cardiopulmonary disease defined as one of the following:\r\n* Unstable angina\r\n* Uncontrolled high blood pressure (ie, systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)\r\n* Cardiomyopathy or history of ischemic heart disease\r\n* Arrhythmia (eg, history of polymorphic ventricular fibrillation or torsade de pointes); permanent atrial fibrillation (a fib) defined as a fib >= 6 months; persistent a fib defined as sustained a fib lasting > 7 days and/or requiring cardioversion in the 4 weeks before screening; however, patients with < grade 3 atrial fibrillation (a fib) for a period of at least 6 months may enroll; grade 3 a fib is symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker), or ablation; patients with paroxysmal a fib are permitted to enroll\r\n* Implantable cardioverter defibrillator\r\n* Congestive heart failure (New York Heart Association [NYHA] class III or IV; or class II with a recent decompensation requiring hospitalization or referral to a heart failure clinic within 4 weeks before screening),\r\n* Myocardial infarction and/or revascularization (eg, coronary artery bypass graft, stent) within 6 months of first dose of study drug\r\n* Patients who had ischemic heart disease who have had ACS, MI, and/or revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll\r\n* Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing)\r\n* Pulmonary hypertension
Current symptomatic congestive heart failure (New York Heart Association >= class II), unstable cardiac arrhythmia requiring therapy (e.g. medication or pacemaker), unstable angina (e.g. new, worsening or persistent chest discomfort), or uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg); or any of the following occurring within 6 months (180 days) prior to first dose of avelumab: myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, or serious cardiac arrhythmia requiring medication; (use of antihypertensive medication to control blood pressure is allowed)
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:\r\n* Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease\r\n* History of documented congestive heart failure (New York Heart Association functional classification III or IV)\r\n* Documented history of cardiomyopathy\r\n* Uncontrolled hypertension (systolic blood pressure [SBP] > 160/diastolic blood pressure [DBP] > 100 despite medical intervention)\r\n* History of myocarditis of any etiology\r\n* History of cardiac surgery\r\n* History of ventricular arrhythmias
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:\r\n* Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease\r\n* History of documented congestive heart failure (New York Heart Association functional classification III or IV)\r\n* Documented history of cardiomyopathy\r\n* Uncontrolled hypertension defined by: systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood Pressure (DBP) > 100 mmHg\r\n* History of myocarditis of any etiology\r\n* History of cardiac surgery\r\n* History of ventricular arrhythmias
Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months prior to start of study therapy; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; uncontrolled Grade ?3 hypertension (diastolic blood pressure ?100 mmHg or systolic blood pressure ?160 mmHg) despite antihypertensive therapy; or history of congenital prolonged QT syndrome.
Significant cardiac history:\r\n* History of myocardial infarction or ischemic heart disease within 1 year before first study drug administration;\r\n* Uncontrolled arrhythmia;\r\n*History of congenital QT prolongation;\r\n* New York Heart Association class III or IV cardiac disease;\r\n* Uncontrolled hypertension: blood pressure consistently greater than 150 mm Hg systolic and 100 mm Hg diastolic in spite of antihypertensive medication
Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:\r\n* Clinically significant cardiac diseases, including any of the following:\r\n** History or presence of serious uncontrolled ventricular arrhythmias \r\n** Clinically significant resting bradycardia\r\n** Any of the following within 3 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE)\r\n** Uncontrolled hypertension defined by a systolic blood pressure (SBP) ? 160 mmHg and/or diastolic blood pressure (DBP) ? 100 mm Hg, with or without anti-hypertensive medication(s)\r\n* Cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)\r\n* Known diagnosis of any condition (i.e. post-hematopoietic or organ transplant, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc.) that requires chronic immunosuppressive therapy; usage of non-steroidal anti-inflammatory medications (NSAIDS) for the treatment of osteoarthritis and uric acid synthesis inhibitors for the treatment of gout are permitted; for questions, please consult the study chair\r\n* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
History of coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II), uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100 mmHg) or cardiac arrhythmias requiring anti-arrrhythmic therapy.
Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:\r\n* Unstable angina\r\n* Myocardial infarction\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without antihypertensive medication\r\n* Ventricular arrhythmias, or supraventricular/nodal arrhythmias not controlled with medications; other cardiac arrhythmias not controlled with medications\r\n* Left ventricular ejection fraction < 20% corrected QT (QTcF) > 470 ms using Fridericia’s correction on the screening electrocardiogram (ECG)\r\n* Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening
CAPMATINIB EXCLUSION CRITERIA: Cardiovascular disorders including:\r\n* Symptomatic congestive heart failure (New York Heart Association class III or IV)\r\n* Personal or family history of congenital long QT syndrome\r\n* Corrected QTc > 480 msec using Fridericia correction on screening electrocardiography (ECG)\r\n* Uncontrolled hypertension (systolic pressure >= 160 mmHg or diastolic pressure >= 100 mmHg on repeated measurement) despite optimal medical management; initiation or adjustment of anti-hypertensive medications are allowed prior to screening
Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:\r\n* Unstable angina within 6 months prior to screening\r\n* Myocardial infarction within 6 months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without antihypertensive medication \r\n** Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Corrected QT (QTcF) > 470 ms using Fridericia’s correction on the screening electrocardiogram (ECG)
Known clinically significant heart disease as evidenced by:\r\n* Myocardial infarction within 6 months of enrollment\r\n* Uncontrolled angina within 6 months of enrollment\r\n* Congestive heart failure New York Heart Association (NYHA) class III or IV, or a history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) within 3 months results in a left ventricular ejection fraction >= 45%\r\n* Clinically significant ventricular arrhythmias\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Bradycardia as indicated by a heart rate < 50 beats per minute at screening visit\r\n* Hypotension as indicated by systolic blood pressure (SBP) =< 85 on 2 consecutive measurements at screening visit\r\n* Uncontrolled hypertension as indicated by SBP > 170 mmHg or diastolic blood pressure (DBP) > 105 mmHg on 2 consecutive measurements at screening visit
Uncontrolled intercurrent illness including, but not limited to:\r\n* Ongoing or active infection requiring parenteral antibiotics\r\n* Impairment of lung function (chronic obstructive pulmonary disease [COPD] > grade 2, lung conditions requiring oxygen therapy) or current dyspnea at rest\r\n* Symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease)\r\n* Known left ventricular ejection fraction (LVEF) < 50%\r\n* Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months\r\n* Uncontrolled hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg, found on two consecutive measurements separated by a 1 or 2-week period despite adequate medical support)\r\n* Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [National Cancer Institute-Common Terminology Criteria for Adverse Events, version 4.0, grade 3])\r\n* Corrected QT using the Fridericia correction formula (QTcF) >= 480 msec on screening electrocardiogram (EKG)\r\n* Known history of QT/correct QT (QTc) prolongation or Torsades de Pointes (TdP)\r\n* ST depression or elevation of >= 1.5 mm in 2 or more leads\r\n* Diarrhea of any cause >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2\r\n* Active autoimmune disease that is not controlled by nonsteroidal or steroidal (< 10 mg of prednisone per day) anti-inflammatory drugs or active inflammatory disease, including small or large intestine inflammation such as active Crohn’s disease or ulcerative colitis, which requires immunosuppressive therapy\r\n* Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary\r\n* Known history of chronic liver disease including cirrhosis, current alcohol abuse, or infection with hepatitis B virus or hepatitis C virus (active or carrier) or renal failure\r\n* Known history of chronic pancreatitis\r\n* Conditions that affect lymphocyte counts, such as human immunodeficiency virus (HIV) infection or immunosuppressive therapy
Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as: \r\n* Unstable angina within 6 months prior to screening\r\n* Myocardial infarction within 6 months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mmHg and/or diastolic blood pressure (DBP) >= 100 mmHg, with or without antihypertensive medication - initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Corrected QT interval (QTc) > 450 msec using Fridericia correction on the screening electrocardiogram (ECG)
Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:\r\n* Unstable angina within 6 months prior to screening\r\n* Myocardial infarction within 6 months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without antihypertensive medication \r\n* Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias\r\n* Supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Corrected QTcF > 470 msec using Fridericia correction on the screening electrocardiogram (ECG)
Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study; impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* Unstable angina within 6 months prior to screening\r\n* Myocardial infarction within 6 months prior to screening\r\n* History of documented congestive heart failure (New York Heart Association functional classification III - IV)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without antihypertensive medication\r\n* Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\r\n* Ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication\r\n* Other cardiac arrhythmia not controlled with medication\r\n* Corrected QT (QTc) > 450 msec using Fridericia correction on the screening electrocardiogram (ECG)
History of serious systemic disease, including myocardial infarction or unstable angina within the last 12 months, history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension (blood pressure of > 140/90 mmHg) at the time of enrollment, New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease
Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* History or presence of serious uncontrolled ventricular or significant arrhythmias\r\n* Any of the following within 6 months prior to registration: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE)\r\n* Uncontrolled hypertension (defined by a systolic blood pressure [SBP] >= 160 mmHg or diastolic blood pressure [DBP] >= 100 mmHg while on anti-hypertensive medications) or history of hypertensive crisis or hypertensive encephalopathy, stroke, TIA, symptomatic peripheral vascular disease, or grade 2 CHF
The subject has serious intercurrent illness as determined by the treating physician, that would compromise either patient safety or study outcomes such as:\r\n* Hypertension (two or more blood pressure [BP] readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment\r\n* Non-healing wound, ulcer, or bone fracture\r\n* Clinically significant cardiac arrhythmias\r\n* Untreated hypothyroidism\r\n* Uncontrolled systemic infection\r\n* Symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug\r\n* Myocardial infarction, stroke, transient ischemic attack within 6 months\r\n* Known active malignancy (other than their glioma) except non-melanoma skin cancer or carcinoma in-situ in the cervix
Uncontrolled hypertension, blood pressure of > 150 mmHg systolic and > 100 mmHg diastolic, or history of hypertensive encephalopathy; subjects with any known uncontrolled inter-current illness including ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] grade [Gr.] 2 or >), myocardial infarction, unstable angina pectoris within the past 12 months
Ponatinib\r\n* History of acute pancreatitis within 1 year of study or history of chronic pancreatitis\r\n* History of alcohol abuse\r\n* Uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)\r\n* Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\r\n** Any history of myocardial infarction, stroke, or revascularization\r\n** Unstable angina or transient ischemic attack within 6 months prior to start of study treatment\r\n** Congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards within 6 months prior to enrollment\r\n** History of clinically significant (as determined by the treating physician) atrial arrhythmia\r\n** Any history of ventricular arrhythmia\r\n** Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism\r\n* Uncontrolled hypertension (diastolic blood pressure > 90 mm Hg; systolic > 140 mm Hg); patients with hypertension should be under treatment on study entry to effect blood pressure control; taking medications that are known to be associated with torsades de pointes\r\n* Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib\r\n* Ocular toxicity present as measured during a comprehensive eye exam
Cardiac conditions as follows:\r\n* Uncontrolled hypertension (blood pressure [BP] >=150/95 mmHg despite medical therapy)\r\n* Left ventricular ejection fraction < 55% measured by echocardiography\r\n* Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiogram (ECG) at rest\r\n* Symptomatic heart failure (New York Heart Association [NYHA] grade II-IV)\r\n* Prior or current cardiomyopathy\r\n* Severe valvular heart disease\r\n* Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy)\r\n* Acute coronary syndrome =< 6 months prior to registration
Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
Known cardiopulmonary disease defined as one of the following:\r\n* Unstable angina\r\n* Uncontrolled high blood pressure (ie, systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mm Hg )\r\n* Congestive heart failure (New York Heart Association [NYHA] class III or IV)\r\n* Myocardial infarction (MI) within 6 months prior to first dose (patients who had ischemic heart disease such as a (acute chest syndrome [ACS]), MI, and/or revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll)\r\n* Cardiomyopathy\r\n* Clinically significant arrhythmia: 1) History of polymorphic ventricular fibrillation or torsade de pointes, 2) Permanent atrial fibrillation [a fib], defined as continuous a fib for >= 6 months, 3) Persistent a fib, defined as sustained a fib lasting > 7 days and/or requiring cardioversion in the 4 weeks before screening, 4) grade 3 a fib defined as symptomatic and incompletely controlled medically, or controlled with device (e.g. pacemaker), or ablation and 5) Patients with paroxysmal a fib or < grade (Gr) 3 a fib for period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen\r\n* Implantable cardioverter defibrillator\r\n* Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing)\r\n* Pulmonary hypertension\r\n* Prolong rate corrected QT (QTc) interval >= 500 msec. calculated according to institutional guidelines\r\n* Left ventricular ejection fraction (LVEF) ? 50% as assessed by echocardiogram or radionuclide angiography
Active cardiac conditions, including any of the following:\r\n* Uncontrolled hypertension (blood pressure [BP] > 150/95 mmHg despite medical therapy)\r\n* Acute coronary syndrome within 6 months prior to starting treatment\r\n* Uncontrolled angina despite medical therapy\r\n* Symptomatic heart failure (New York Heart Association [NYHA] class II-IV despite medical therapy)\r\n* Baseline left ventricular ejection fraction (LV EF) < 50% measured by either echocardiography or multigated acquisition (MUGA) scan\r\n* Severe valvular heart disease\r\n* Atrial fibrillation with ventricular rate > 100 beats per minute (bpm) on electrocardiogram (EKG) at rest
Cardiac conditions as follows:\r\n* Active coronary artery disease, unstable or newly diagnosed angina or myocardial infarction less than 12 months prior to first study drug administration\r\n* Class II-IV New York Heart Association (NYHA) congestive heart failure\r\n* Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg and diastolic BP > 90 mmHg for 24 hours) despite optimal medical management; blood pressure must be below 140/90 mmHg at screening; subjects with a history of hypertension who are receiving treatment with calcium channel blockers that are cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates should be changed to an alternative antihypertensive medication prior to first study drug administration\r\n* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\r\n* Corrected QT (QTc) (Frederica) prolongation > 480 msec\r\n* Subjects with valvular heart disease Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade 2\r\n* Known left ventricular ejection fraction (LVEF) < 50%
Patients with significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure [BP] > 115 mmHg), unstable angina, congestive heart failure (> New York Heart Association [NYHA] class II), poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty or myocardial infarction within the last 6 months, or uncontrolled atrial or ventricular cardiac arrhythmias
No clinically significant cardiovascular disease, defined as one of the following:\r\n* Uncontrolled hypertension (blood pressure > 150/100 mm/Hg at the time of enrollment); patients with hypertension and blood pressure =< 150/100 mm Hg on stable antihypertensive regimen are eligible\r\n* History of myocardial infarction or unstable angina < 24 weeks prior to randomization\r\n* New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris\r\n* Grade II or greater peripheral vascular disease
Significant medical co-morbidities as described below:\r\n* Cardiac disease:\r\n** Congestive heart failure > class II New York Heart Association (NYHA)\r\n** Unstable angina (anginal symptoms at rest), or new-onset angina (begun within the last 3 months), or myocardial infarction within the 6 months prior to enrollment, or\r\n** Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\r\n** Known history of QTc prolongation or torsades de pointes\r\n* Grade 3 hypertension (systolic blood pressure [SBP] >= 160 mm Hg and/or diastolic blood pressure [DBP] >= 100 mm Hg despite maximal medical therapy)\r\n* Thrombotic, embolic, venous, or arterial events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months\r\n* Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C\r\n* Previous or concurrent cancer that is distinct in primary site or histology from breast cancer within 5 years prior to enrollment EXCEPT cervical cancer in situ, treated non-melanoma skin cancers, superficial bladder tumors (Ta and Tis)
Uncontrolled hypertension (systolic blood pressure [BP] greater than [>] 150 millimeters of mercury [mmHg] and/or diastolic BP > 100 mmHg), unstable angina, congestive heart failure of any New York Heart Association classification, serious cardiac arrhythmia that requires treatment with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia, and history of myocardial infarction within 6 months of enrollment
No cardiac risk factors including:\r\n* Uncontrolled high blood pressure (systolic blood pressure > 150)\r\n* Unstable angina\r\n* History of documented myocardial infarction or cerebrovascular accident\r\n* New York Heart Association class III or IV heart failure
Uncontrolled hypertension (sustained systolic > 150 mmHg and/or diastolic > 100 mmHg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including: myocardial infarction or unstable angina within =< 6 months prior to the first study treatment; New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia); significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior of study enrollment; prior history of hypertensive crisis or hypertensive encephalopathy
Patients with any of the following cardiovascular diseases are excluded:\r\n* History of myocardial infarction within six months\r\n* Unstable angina\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* History of documented congestive heart failure (New York Heart Association [NYHA] classification of III or IV) or documented cardiomyopathy\r\n* Valvular disease with documented compromise in cardiac function\r\n* If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines; patients with the following risk factor should have a baseline cardiac function assessment:\r\n** Prior treatment with anthracyclines\r\n* Any prior history of hypertensive crisis or hypertensive encephalopathy\r\n* Patients may not have any evidence of pre-existing inadequately controlled hypertension (defined as a systolic blood pressure [BP] of > 140 mmHg or a diastolic BP of > 90 mmHg), and must have a normal blood pressure (=< 140/90 mmHg) taken in the clinic setting by a medical professional within 2 weeks prior to starting study\r\n* Clinically significant peripheral vascular disease\r\n* Vascular disease including aortic aneurysm or dissection\r\n* History of stroke, transient ischemic attack or subarachnoid hemorrhage\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Cardiac conduction abnormality requiring a pacemaker\r\n* Known history of QT/corrected QT interval (QTc) prolongation or torsades de pointes\r\n* QTc prolongation > 470 msec or other significant electrocardiogram (ECG) abnormality noted during screening
Clinically significant cardiovascular disease including:\r\n* Myocardial infarction within 6 months prior to screening\r\n* Uncontrolled angina within 3 months prior to screening\r\n* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition (MUGA) scan performed within 3 months results in a left ventricular ejection fraction that is >= 45%\r\n* History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes)\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening; patients with initially elevated systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg are eligible if they undergo medical management and are re-screened
Significant cardiac disease or risk factors as indicated by MUGA or echocardiogram performed =< 60 days prior to registration and/or by presence of any of the following:\r\n* History of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade >= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria class >= II\r\n* Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease\r\n* High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block [second degree AV-block Type 2 [Mobitz 2] or third degree AV-block])\r\n* Significant symptoms (grade >= 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia\r\n* Myocardial infarction within 12 months prior to randomization\r\n* Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure >100 mmHg)\r\n* Evidence of transmural infarction on electrocardiogram (ECG)\r\n* Requirement for oxygen therapy
Patients with clinically significant cardiovascular disease; this includes:\r\n* Poorly controlled hypertension (> 140 mm Hg and > 90 mm Hg for systolic and diastolic blood pressure [BP]) are ineligible\r\n* Myocardial infarction or unstable angina within 6 months prior to registration; New York Heart Association (NYHA) grade II or greater congestive heart failure \r\n* Cardiac arrhythmia requiring medication
Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including:\r\n* History of myocardial infarction in the past year or unstable, severe cardiovascular disease including angina or congestive heart failure (CHF) with symptoms at rest, or clinically significant abnormalities on the electrocardiogram (ECG)\r\n* Clinically significant and/or unstable pulmonary, gastrointestinal, hepatic, or renal disease\r\n* Insulin-requiring diabetes or uncontrolled diabetes mellitus,\r\n* Uncontrolled hypertension (systolic blood pressure [BP] > 170 or diastolic blood pressure [BP] > 100)
Cardiac risk factors including: 1) uncontrolled high blood pressure (systolic blood pressure > 150); 2) unstable angina; 3) history of documented myocardial infarction or cerebrovascular accident; 4) New York Heart Association class III or IV heart failure
Clinically significant heart disease defined as:\r\n* Myocardial infarction within 6 months of screening visit\r\n* Uncontrolled angina within 3 months of screening visit\r\n* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within three months of the screening visit results in a left ventricular ejection fraction that is >= 45%\r\n* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes)\r\n* Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on the screening electrocardiogram (ECG) > 470 msec\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Hypotension (systolic blood pressure < 86 mmHg) or bradycardia with a heart rate of < 50 beats per minute on the screening ECG, unless pharmaceutically induced and thus reversible (i.e. beta blockers) or known, chronic asymptomatic baseline heart rate\r\n* Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit
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* Poorly controlled high blood pressure (>= 150 mmHg systolic and/or 100 mmHg diastolic) despite treatment\r\n* New York Heart Association class II-IV congestive heart failure\r\n* Serious cardiac arrhythmia requiring medication\r\n* Myocardial infarction or unstable angina =< 6 months prior to registration/randomization\r\n* Clinically significant peripheral vascular disease\r\n* Deep venous thrombosis or pulmonary embolus =< 1 year of registration/randomization\r\n* Ongoing need for full-dose oral or parenteral anticoagulation\r\n* Ongoing anti-platelet treatment other than low-dose aspirin (i.e., aspirin 81 mg by mouth daily)\r\n* Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices, etc.)\r\n* Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture\r\n* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =< 6 months prior to registration/randomization\r\n* History of central nervous system (CNS) disease (e.g., vascular abnormalities, etc.), clinically significant stroke or transient ischemic attack (TIA) =< 6 months prior to registration/randomization, seizures not controlled with standard medical therapy\r\n* Radiographically documented tumor invading major blood vessels\r\n* History of hypertensive crisis or hypertensive encephalopathy
The patient has cardiac conditions as follows: uncontrolled hypertension (blood pressure [BP] > 160/100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association class II or above), baseline left ventricular ejection fraction (LVEF) =< 50%, prior or current cardiomyopathy, atrial fibrillation with heart rate > 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction [MI] within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly)
Patients with clinically significant cardiovascular disease, including: \r\n* Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg\r\n* Myocardial infarction or unstable angina < 6 months prior to registration\r\n* New York Heart Association (NYHA) class II or higher congestive heart failure \r\n* Serious cardiac arrhythmia requiring medication\r\n* Cancer Therapy Evaluation Program (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) \r\n* Corrected QT (QTc) interval > 470 msec (CTCAE grade 2 or greater)
Clinically significant cardiovascular disease including:\r\n* Myocardial infarction within 6 months\r\n* Uncontrolled angina within 3 months\r\n* Congestive heart failure New York Heart Association (NYHA) class 3 of 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless screening echocardiogram or multi-gated acquisition scan performed within 3 months results in a left ventricular ejection fraction that is >= 45%\r\n* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the screening visit\r\n* Bradycardia as indicated by a heart rate of < 50 beats per minute on the screening electrocardiogram (ECG)\r\n* Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg
Clinically significant cardiovascular disease, including:\r\n* Myocardial infarction within 3 months of enrollment\r\n* Uncontrolled angina within 3 months of enrollment\r\n* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within 3 months results in a left ventricular ejection fraction >= 45%\r\n* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Hypotension as indicated by systolic blood pressure < 86 mmHg on 2 consecutive measurements at the screening visit\r\n* Bradycardia as indicated by a heart rate < 50 beats per minute at the screening visit;\r\n* Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg on 2 consecutive measurements at the screening visit;\r\n* Electrocardiogram (EKG) demonstrating equal to or greater than grade III toxicity according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Clinically significant cardiovascular disease including:\r\n* Myocardial infarction within 6 months of screening visit\r\n* Uncontrolled angina within 3 months of screening visit\r\n* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within three months of the screening visit results in a left ventricular ejection fraction that is >= 45%\r\n* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes)\r\n* Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on the screening electrocardiogram (ECG) > 470 msec\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Hypotension (systolic blood pressure < 86 mmHg or bradycardia with a heart rate of < 50 beats per minute on the screening ECG, unless pharmaceutically induced and thus reversible [i.e. beta blockers])\r\n* Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit
No clinically significant cardiovascular disease including:\r\n* Myocardial infarction (MI) within 6 months\r\n* Uncontrolled angina within 3 months\r\n* Congestive heart failure (CHF) with New York Heart Association (NYHA) class 3 or 4, or patients with NYHA class 3 or 4 in the past, unless a screening echocardiogram (echo) or multi gated acquisition scan (MUGA) performed within three months demonstrates an ejection fraction (EF) > 45%\r\n* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Hypotension (systolic blood pressure [BP] < 86 mmHg) or bradycardia (< 50 beats per minute [bpm]) at screening \r\n* Uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg at screening)
Clinically significant heart disease as evidenced by:\r\n* Myocardial infarction within 6 months of enrollment\r\n* Uncontrolled angina within 6 months of enrollment\r\n* Congestive heart failure New York Heart Association (NYHA) class III or IV, or a history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 3 months results in a left ventricular ejection fraction >= 45%\r\n* Clinically significant ventricular arrhythmias\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Bradycardia as indicated by a heart rate < 50 beats per minute at screening visit\r\n* Hypotension as indicated by systolic blood pressure (SBP) =< 85 on 2 consecutive measurements\r\n* Uncontrolled hypertension as indicated by SBP > 170 mmHg or diastolic blood pressure (DBP) > 105 mmHg on 2 consecutive measurements at screening visit
Clinically significant cardiovascular disease including:\r\n* Myocardial infarction within 6 months prior to screening;\r\n* Uncontrolled angina within 3 months prior to screening;\r\n* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is >= 45%\r\n* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Hypotension as indicated by systolic blood pressure < 86 mmHg at the screening visit\r\n* Bradycardia as indicated by a heart rate of < 50 beats per minute at the screening visit \r\n* Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit
Significant cardiovascular disease, including\r\n* Uncontrolled hypertension: systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg documented on 2 consecutive measurements taken at least 24 hours apart\r\n* Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug\r\n* History of class III or IV congestive heart failure, as defined by the New York Heart Association\r\n* History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)\r\n* Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well-controlled with anti-arrhythmic medication; and/or\r\n* Coronary or peripheral artery bypass graft within 6 months of screening
Active cardiac disease\r\n* Any prior myocardial infarction (asymptomatic changes on electrocardiogram [EKG] suggestive of old myocardial infarction [MI] is not an exclusion)\r\n* Documented congestive heart failure (CHF)\r\n* Current use of any therapy specifically for CHF\r\n* Current uncontrolled hypertension (diastolic > 100 mmHg or systolic > 200 mmHg)\r\n* Clinically significant pericardial effusion
Uncontrolled intercurrent illness including, but not limited to:\r\n* Ongoing or active infection requiring parenteral antibiotics\r\n* Impairment of lung function (chronic obstructive pulmonary disease [COPD] > grade 2, lung conditions requiring oxygen therapy)\r\n* Symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease)\r\n* Known / previously documented left ventricular ejection fraction (LVEF) < 50% within 6 months of trial enrollment\r\n* Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months\r\n* Uncontrolled hypertension within 2 weeks of study initiation (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg, found on two consecutive measurements separated by a 1 or 2-week period despite adequate medical support)\r\n* Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [National Cancer Institute -Common Terminology Criteria for Adverse Events, version 4.0, grade 3])\r\n* QT interval corrected for heart rate using Fridericia's formula (QTcF) >= 480 msec on screening electrocardiogram (EKG)\r\n* Known history of QT/corrected QT interval (QTc) prolongation or torsades de pointes (TdP)\r\n* ST depression or elevation of >= 1.5 mm in 2 or more leads\r\n* Diarrhea of any cause >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2\r\n* Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary\r\n* Patients with symptomatic brain metastases (patients with a history of brain metastases must be clinically stable for more than 4 weeks from completion of radiation treatment)\r\n* Patients with known history of chronic liver or renal failure\r\n* Patients with known history of chronic or acute pancreatitis
Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:\r\n* Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated\r\n* Severe hepatic impairment (Child-Pugh class C)\r\n* History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents\r\n* Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment\r\n* Active or symptomatic viral hepatitis or chronic liver disease\r\n* History of pituitary or adrenal dysfunction\r\n* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline\r\n* Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy\r\n* Uncontrolled diabetes mellitus\r\n* Active psychiatric condition
Clinically significant cardiovascular disease including myocardial infarction within 6 months, uncontrolled angina within 3 months, congestive heart failure New York Heart Association (NYHA) class 3 or 4, uncontrolled hypertension as indicated by systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg at the screening visit
Uncontrolled hypertension (sustained systolic > 150 mmHg and/or diastolic > 100 mmHg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including:\r\n* Myocardial infarction or unstable angina within =< 6 months prior to the first study treatment\r\n* New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF)\r\n* Serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia)\r\n* Peripheral vascular disease > grade 3 (i.e. symptomatic and interfering with activities of daily living requiring repair or revision)
Any contra-indications to bevacizumab which include but are not limited to recent\r\n* Any previous venous thromboembolism > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3\r\n* Severe uncontrolled hypertension (systolic blood pressure >= 150 mmHg and/or diastolic blood pressure >= 100 mmHg)\r\n* Cardiovascular disease including stroke of myocardial infarction =< 6 months prior to study enrollment, New York Heart Association grade 2 or greater congestive heart failure, serious cardiac arrhythmia uncontrolled by medication\r\n* Hemorrhagic brain metastases; asymptomatic (not requiring escalating doses of steroids) brain metastases are acceptable\r\n* History of severe proteinuria (urine dipstick >= 2+ or 24 hour [hr] urine > 2 gm/24 hr)\r\n* Prior history of hypertensive crisis or hypertensive encephalopathy\r\n* History of a central nervous system disease (e.g. seizures) unrelated to cancer unless adequately treated with standard medical therapy\r\n* Significant vascular disease (e.g. aortic aneurysm requiring surgical repair) =< 6 months prior to study enrollment\r\n* History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within the last 3 months\r\n* Evidence of a bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)\r\n* Current or recent (within 10 days of study drug start) use of aspirin (> 325 mg daily), clopidogrel (> 75 mg daily)\r\n* Recent initiation of full dose oral or parental anticoagulants that have not been in place for at least 2 weeks\r\n* Tumor invading or abutting major blood vessels\r\n* Tumor histology classified by squamous cell histology\r\n* Any history of abdominal fistula or gastrointestinal tract (GI) perforation within 6 months of study enrollment
Patients with clinically significant cardiovascular disease. This includes: 1) Uncontrolled hypertension, defined as systolic > 140 mm Hg or diastolic > 90 mm Hg; 2) Myocardial infarction or unstable angina < 6 months prior to registration; 3) New York Heart Association (NYHA) Grade II or greater congestive heart failure; 4) Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate
Evidence of current uncontrolled cardiovascular conditions, including sustained hypertension (systolic blood pressure [SBP] > 150 mmHg on two or more readings one week apart without normalization in between), clinically significant uncontrolled cardiac arrhythmias, symptomatic class III-IV New York Heart Association (NYHA) congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
Clinically significant cardiovascular disease, defined as any of the following conditions: i. Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) ii. Prior history of hypertensive crisis or hypertensive encephalopathy iii. Myocardial infarction within 6 months iv. Unstable angina v. New York heart association grade II or greater congestive heart failure (Appendix C) vi. Serious cardiac arrhythmia requiring medication vii. LVEF < 50% or below institutional limit of normal f) History of stroke of TIAs within 6 months prior to Day 1 g) Grade II or greater peripheral vascular disease within 1 year prior to study entry or other significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 h) Serious, non-healing wound, active ulcer, or untreated bone fracture i) History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 j) Known hypersensitivity to any component of bevacizumab k) Known CNS disease, except for stable or regressing brain metastases. l) Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) m) Psychiatric illness/social situations that would limit compliance with study requirements. n) Significant ocular issues including history of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration. The risk factors for RVO are listed below. Patients should be excluded if they have the following conditions:
SELUMETINIB ARM: Cardiac conditions as follows:\r\n* Uncontrolled hypertension (blood pressure [BP] >= 150/95 despite optimal therapy)\r\n* Heart failure NYHA class II or above\r\n* Prior or current cardiomyopathy\r\n* Baseline left ventricular ejection fraction (LVEF) =< 50%\r\n* Atrial fibrillation with heart rate > 100 bpm\r\n* Unstable ischemic heart disease (myocardial infarction [MI] within 6 months prior to starting treatment, or angina requiring use of nitrates more than once weekly)
Recent (< 6 months) myocardial infarction, unstable angina, coronary artery bypass surgery (CABG) or stent placement in the last 2 years, difficult-to-control congestive heart failure, uncontrolled hypertension (systolic blood pressure > 160 mm or a diastolic blood pressure [BP] > 110 mm under normal conditions and while on appropriate anti-hypertensive medications), or difficult-to-control cardiac arrhythmias
Clinically significant cardiac disease (class III, or IV of the New York Heart Association classification; unstable angina pectoris, myocardial infarction within 6 months or is post angioplasty or stenting within 6 months; clinically significant cardiac arrhythmia, or uncontrolled hypertension (i.e., systolic blood pressure > 150 mm Hg, diastolic blood pressure > 90 mmHg) despite anti-hypertensive medication;
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension (persistent systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications) or arrhythmia, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, ischemic or severe valvular heart disease, or myocardial infarction within 6 months prior to the first dose of study treatment
Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:\r\n* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n** History or presence of serious uncontrolled ventricular arrhythmias\r\n** Clinically significant resting bradycardia\r\n** Left ventricular ejection fraction (LVEF) assessed by 2-dimensional (D) echocardiogram (ECHO) =< 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (whichever is higher)\r\n** Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA), pulmonary embolism (PE)\r\n** Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication(s)\r\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\r\n* Cirrhosis, chronic active hepatitis or chronic persistent hepatitis\r\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)\r\n* Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin\r\n* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
Patients with clinically significant cardiovascular or cerebrovascular disease:\r\n* History of cerebrovascular accident or transient ischemic attack within past 6 months\r\n* Uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg or systolic blood pressure (BP) > 180 mm Hg if diastolic blood pressure < 90 mm Hg, on at least 2 repeated determinations on separate days within past 3 months\r\n* Myocardial infarction, coronary artery bypass graft (CABG) or unstable angina within the past 6 Months\r\n* New York Heart Association grade III or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris within past 6 months\r\n* Clinically significant peripheral vascular disease within past 6 months\r\n* Pulmonary embolism, deep vein thrombosis (DVT), or other thromboembolic event within past 6 months
Preexisting cardiovascular disease. The only exception being well controlled essential hypertension with a sitting blood pressure (B.P.) of < 160 systolic and < 90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction > 8 months ago. A past history of any of the following conditions is considered as exclusions to study participation:
Uncontrolled intercurrent illness including, but not limited to,\r\n* Ongoing or active infection\r\n* Psychiatric illness/social situations that would limit compliance with study requirements\r\n* Clinically significant cardiac disease including any of the following:\r\n** Congestive heart failure requiring treatment (New York Heart Association grade >= 2), left ventricular ejection fraction (LVEF) < 50% as determined by multi gated acquisition scan (MUGA) scan or echocardiogram\r\n** Uncontrolled hypertension (defined as systolic blood pressure [BP] >= 160 mmHg OR diastolic BP >= 100 mmHg despite maximal anti-hypertensive medications: refer to World Health Organization [WHO]-International Society of Hypertension [ISH] guidelines)\r\n** History or presence of clinically significant ventricular arrhythmias, atrial fibrillation, resting bradycardia, or conduction abnormality\r\n** Unstable angina pectoris or acute myocardial infarction < 3 months prior to starting study treatment\r\n** Corrected QT using the Fredericia's formula (QTcF) > 450 msec (males); > 470 msec (females)\r\n** History of congenital long QT syndrome
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* History or presence of serious uncontrolled ventricular arrhythmias\r\n* Clinically significant resting bradycardia\r\n* Ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of corrected QTc interval to > 480 msec\r\n•\t* Left ventricular ejection fraction (LVEF) assessed by 2-dimensional (2-D) echocardiogram (ECHO) < 50% or lower limit of normal (whichever is the higher), or 2-D multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (whichever is the higher)\r\n* Any of the following =< 180 days prior to starting study drug: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA)\r\n* Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic (D)BP >= 100 mm Hg, with or without anti-hypertensive medication(s); initiation or adjustment of antihypertensive medication(s) is allowed prior to study entry
Clinically significant cardiovascular disease as evidenced by: myocardial infarction within 6 months of screening; uncontrolled angina within 3 months of screening; New York Heart Association (NYHA) class 3 or 4 congestive heart failure; clinically significant ventricular arrhythmia; Mobitz II/2nd degree/or 3rd degree heart block without a pacemaker in place; uncontrolled hypertension (HTN) (systolic > 180 mmHg or diastolic > 105 mmHg at screening)
Clinically significant cardiovascular disease within 6 months of study treatment including:\r\n* Severe or unstable angina\r\n* Myocardial infarction\r\n* Symptomatic congestive heart failure\r\n* New York Heart Association (NYHA) (class II-IV heart disease)\r\n* Arterial or venous thromboembolic events (such as pulmonary embolism cerebrovascular accident including transient ischemic attacks)\r\n* History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes)\r\n* Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening electrocardiogram (EKG) > 470 msec\r\n* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place\r\n* Uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
Significant cardiovascular disease precluding an exercise program, including recent (within 6 months) myocardial infarction or stroke, pulmonary edema, myocarditis, pericarditis, unstable angina, pulmonary embolism/deep venous thrombosis (PE/DVT), uncontrolled hypertension (systolic blood pressure [SBP] > 200; diastolic blood pressure [DBP] > 110), uncontrolled arrhythmia, heart failure; or
Patients must not have cardiovascular risk factors including unstable angina, history of documented myocardial infarction or cerebrovascular accident, coronary artery bypass surgery, or New York Heart Association class III or IV heart failure; patients must not have known uncontrolled hyperlipidemia (defined as low-density lipoprotein cholesterol [LDL-C] >= 190 mg/dL or triglycerides >= 500 mg/dL) within the last 3 years prior to registration or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration
Active cardiac disease including any of the following:\r\n* Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)\r\n* Unstable angina\r\n* Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T- wave, multifocal complexes)\r\n* Myocardial infarction within 14 days prior to the date of proposed Definity administration\r\n* Uncontrolled systemic hypertension (systolic blood pressure [BP] > 180 mm Hg and/or diastolic BP > 100 mm Hg) despite optimal medical management
Active cardiac disease including any of the following:\r\n* Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)\r\n* Unstable angina\r\n* Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes)\r\n* Myocardial infarction within 1 year prior to the date of proposed Definity administration\r\n* Uncontrolled systemic hypertension (systolic blood pressure [BP] > 150 mmHg and/or diastolic BP > 90 mmHg despite optimal medical management)
Any medical condition that in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy; specifically, uncontrolled hypertension (systolic > 150 and/or diastolic > 100), unstable angina, congestive heart failure of any New York Heart Association (NYHA) classification, serious cardiac arrhythmia requiring treatment (exception: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment
History or evidence of cardiovascular risk including any of the following: \r\n* Current uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg) or unstable angina\r\n* History of serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia)\r\n* History of myocardial infarction within 6 months of day 1 of dosing \r\n* History of congestive heart failure (CHF) of New York Heart Association (NYHA) criteria
Potentially life-threatening arrhythmia; myocardial infarct within the previous 3 months; unstable angina, or angina at rest; congestive heart failure (New York Heart Association Functional Classification class II or worse), uncontrolled hypertension (systolic blood pressure [BP] > 160 or diastolic BP > 100)
Uncontrolled hypertension (systolic blood pressure [BP] > 150 millimeters of mercury [mmHg] and/or diastolic BP > 100 mmHg), unstable angina, congestive heart failure (CHF) of any New York Heart Association (NYHA) classification (Class II or greater), serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment
Clinically significant cardiovascular disease including:\r\n* GROUP 2 (trametinib arm): LVEF < LLN\r\n* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months\r\n* Uncontrolled angina within 3 months\r\n* GROUP 1 and GROUP 3 (non-trametinib arms): Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within 3 months results in a left ventricular ejection fraction that is >= 45%\r\n* GROUP 2 (trametinib arm): Any history of congestive heart failure of any NYHA class for patients assigned to Group 2 (trametinib arm)\r\n* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)\r\n* Patients with intra-cardiac defibrillators or permanent pacemakers\r\n* Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the screening visit\r\n* Bradycardia as indicated by a heart rate of < 40 beats per minute on the screening electrocardiogram (ECG)\r\n* Treatment refractory hypertension defined as a blood pressure of systolic > 160 mmHG and/or diastolic > 95 mmHG which cannot be controlled by anti-hypertensive therapy\r\n* Corrected QT interval (QTC) >= 480 milliseconds\r\n* Known cardiac metastases
Participants may not have any evidence of ongoing inadequately controlled hypertension (defined as a systolic blood pressure [BP] of > 140 mmHg or a diastolic BP of > 90 mmHg); patients with hypertension may not be on more than three antihypertensive medications for management of their blood pressure (medications that combine two anti-hypertensives into one are considered as two medications); it is strongly recommended that patients who require three antihypertensive medications for baseline management of pre-existing hypertension be actively followed by a cardiologist or blood pressure specialist for management of BP while on protocol
Adequately controlled blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic) taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of 3 antihypertensive medications; a cardiologist or blood pressure specialist must evaluate patients who are on 3 antihypertensive medications within 4 weeks of enrollment
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Cycle 1 Day 1
History of uncontrolled hypertension (Blood pressure ? _140/90 mmHg and change in antihypertensive medication within 7 days prior to randomization) that is not well managed by medication and the risk of which may be precipitated by a VEGF inhibitor therapy.
Participants with a history of hypertension must be adequately controlled with antihypertensive medication and blood pressure (BP) must be less than 140/90 mmHg prior to initiation of ziv-aflibercept
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ?150/90 millimeters of mercury (mmHg) at Screening and no change in antihypertensive medications within 1 week before Cycle 1/Day 1
Adequately controlled blood pressure with or without antihypertensive medications defined as blood pressure (BP) < 140/90 mmHg at screening and no change in antihypertensive mediation within 1 week prior to the screening visit
Adequately controlled blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic) taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of 3 antihypertensive medications; patients who are on 3 antihypertensive medications are highly recommended to be followed by a cardiologist or blood pressure specialist for management of BP while on protocol
Adequately controlled blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic) taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of 3 antihypertensive medications; patients who are on 3 antihypertensive medications are highly recommended to be followed by a cardiologist or blood pressure specialist for management of BP while on protocol
Patients must have adequately controlled blood pressure (BP), with a BP no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of three antihypertensive medications; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or blood pressure specialist for management of blood pressure while on protocol
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as: BP less than 95th percentile for sex, age, and height/length at screening (as per National Heart Lung and Blood Institute guidelines) and no change in antihypertensive medications within 1-week prior to Cycle 1/Day 1. Osteosarcoma subjects 18 to 25 years should have BP ?150/90 mm Hg at screening and no change in antihypertensive therapy within 1 week prior to Cycle 1/Day 1.
Patients with uncontrolled hypertension (requirement for more than 2 blood pressure [BP] medications or grade 2 or higher BP elevation while on adequate doses of not more than 2 antihypertensive agents) are excluded from the study
Patients with BP combination treatment with more than two antihypertensive medications are ineligible
Adequately controlled blood pressure; (defined as systolic blood pressure [SBP] of < 140 mmHg and diastolic blood pressure [DBP] of < 90 mmHg) on maximum of three antihypertensive medications; participants must have a blood pressure (BP) of < 140/90 taken in the clinic or hospital setting by a medical professional within 2 weeks prior to starting on study; it is strongly recommended that participants who are on 3 antihypertensive medications be followed by a cardiologist or a primary care physician for management of BP while on study
Adequately controlled blood pressure (systolic blood pressure [SBP] =< 140; diastolic blood pressure [DBP] =< 90 mmHg) on maximum of three antihypertensive medications; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; it is strongly recommended that patients who are on three antihypertensive medications must be actively followed by a cardiologist or a primary care physician for management of BP while on protocol; patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to cediranib alone and the combination of olaparib and cediranib arms
Blood pressure (BP) ? 140/90 millimeter of mercury (mmHg) at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1.
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Cycle 1 Day 1.
Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP less than or equal to 150/90 mm Hg at Screening and no change in antihypertensive therapy within 1 week prior to the Cycle1/Day1
Participants may not have any evidence of ongoing inadequately controlled hypertension (defined as a systolic blood pressure [BP] of > 140 mmHg or a diastolic BP of > 90 mmHg); patients with hypertension may not be on more than three antihypertensive medications for management of their blood pressure (medications that combine two anti-hypertensives into one are considered as two medications); it is strongly recommended that patients who require three antihypertensive medications for baseline management of pre-existing hypertension be actively followed by a cardiologist or blood pressure specialist for management of BP while on protocol
Blood pressure < 150/90 at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to initiation of treatment
Adequate blood pressure (BP) control with or without antihypertensive medications
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than 150/90 mmHg at screening and no change in antihypertensive medications within 1 week before Cycle 1/Day 1 (C1D1).
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ?150/90 mmHg at Screening and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1 (C1/D1)
Patients may not have any evidence of pre-existing inadequately controlled hypertension (defined as a systolic blood pressure [BP] of > 140 mmHg or a diastolic BP of > 90 mmHg), and must have a normal blood pressure (=< 140/90 mmHg) taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of three antihypertensive medications; patients who are on three antihypertensive medications must be actively followed by a cardiologist or blood pressure specialist for management of blood pressure while on protocol
Blood pressure (BP) ?140/90 millimeters of mercury (mmHg) at Screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1.
Patients with a history of hypertension should be well controlled (blood pressure [BP] =< 140/90) on a regimen of antihypertensive therapy
Adequately controlled blood pressure with or without antihypertensive medications defined as blood pressure (BP) < 150/90 mmHg at screening
Be using more than one antihypertensive drug
Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ?150/90 mmHg at Screening and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1.
Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
Uncontrolled high blood pressure defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP 90 mmHg with or without anti-hypertensive medication; patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria
Diastolic BP =< 90 mg HG
Uncontrolled hypertension despite appropriate medical therapy (blood pressure [BP] greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit); Note: patients may be rescreened after adjustment of antihypertensive medications
Uncontrolled high blood pressure defined as systolic blood pressure (BP) greater than or equal to 150 mmHg or diastolic BP greater than or equal to 100 mmHg with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg.
Uncontrolled or poorly controlled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg); Note: an isolated reading that is not sustained will be permitted
Uncontrolled hypertension defined as sustained systolic BP > 150 mmHg or diastolic BP > 90 mmHg. (Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.) Patients requiring greater than or equal to 3 BP medications are not eligible.
No grade 3 or 4 hypertension (systolic blood pressure [BP] > 160 and or diastolic BP > 100) that cannot be controlled with medication prior to registration
History of any of the following cardio-vascular condition:\r\n* Myocardial infarction (MI)\r\n* Unstable angina\r\n* Coronary artery bypass grafting (CABG)\r\n* Coronary angioplasty or stenting\r\n* Symptomatic peripheral arterial disease (PAD)\r\n* History of symptomatic chronic congestive heart failure (CHF)\r\n* History of cerebrovascular accidents including transient ischemic attacks (TIA)\r\n* Corrected QT interval (QTc) > 480 msec\r\n* Uncontrolled hypertension (systolic blood pressure [BP] > 150 mm Hg or diastolic BP of > 90 mm Hg); if the screening BP is elevated, adjustments in anti-hypertensives are permitted and a re-screening will be permitted for BP assessment with three consecutive values obtained 2 minutes apart; the 3 values have to be below 150/90 mm Hg for eligibility and can only be obtained after 2 days of the last change in anti-hypertensive medication; use of clonidine is not permissible for adjusting the BP during this period
Uncontrolled hypertension (blood pressure [BP] > 150/100 mmHg)
Uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg)
No evidence of uncontrolled hypertension as documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart; the baseline systolic BP readings must be =< 140 mm Hg, and the baseline diastolic BP readings must be =< 90 mm Hg; use of antihypertensive medications to control BP is allowed
Uncontrolled hypertension. Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy. Note that this is NOT a criterion related to particular blood pressure (BP) results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes
Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 170 or diastolic pressures above 110 despite anti-hypertensive therapy. Note that this is NOT a criterion related to particular blood pressure (BP) results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (for example doctor’s visit related stress i.e. \white coat syndrome\.
Uncontrolled cardiac disease, including unstable angina, uncontrolled hypertension (i.e. sustained systolic BP >160 mmHg or diastolic BP >90 mmHg), or need to change medication due to lack of disease control within 6 weeks prior to the provision of consent;
Uncontrolled hypertension defined as a systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medications
Uncontrolled hypertension (HTN); sustained blood pressure (BP) greater than 150/100 mmHg
Blood pressure (BP) < 150 mmHg (systolic) and < 90 mmHg (diastolic); initiation or adjustment of BP medication is permitted prior to registration provided that the average of three BP readings at a visit prior to registration is < 150/90 mmHg; NOTE: all patients with secretory pheochromocytoma or paraganglioma are REQUIRED to: 1) be evaluated in consultation by a hypertension specialist with specific experience in the management of hypertension in the setting of catecholamine-secreting tumors (usually an endocrinologist, nephrologist, or a cardiologist), and in the setting of hormone-associated hypertension) receive alpha- and beta-adrenergic blockade for at least 7-14 days prior to initiation of lenvatinib; the hypertension specialist of record for each patient should be committed to closely following the patient during the clinical study with evaluation by said specialist required at cycle 1 and 2 and thereafter on an as needed basis
Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg) or other medical condition that could jeopardize the assessment of toxicity on study
Prior exposure to BP1001
Prior exposure to BP1001
Uncontrolled hypertension (systolic blood pressure [BP] >= 140 mmHg or diastolic BP >= 90 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg despite optimal medical management
Resting systolic blood pressure (BP) < 100 mmHg
Hypertension defined as systolic BP >= 140 mmHg or diastolic BP >= 90 mmHg despite optimal medical management
Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy (initiation or adjustment of blood pressure (BP) medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 140/90 mm Hg)
Uncontrolled hypertension defined as a systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well controlled on medication are eligible.)
Severe hypertension (diastolic BP > 100 on medication).
Uncontrolled hypertension (systolic blood pressure [BP] >= 140 mmHg or diastolic BP >= 90 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Uncontrolled high blood pressure defined as systolic BP greater than or equal to 150 mmHg or diastolic BP greater than or equal to 100 mmHg with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
uncontrolled hypertension (systolic BP> 180 mmHg or diastolic BP > 100 mmHg despite antihypertensive treatment);
Severe hypertension (diastolic BP > 100 on medication)
Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
Mean arterial blood pressure (BP) of less than 70 mmHg
No history of the following\r\n* Prior brain metastases\r\n* Leptomeningeal disease\r\n* Seizures\r\n* Class 3 or 4 congestive heart failure\r\n* Uncontrolled hypertension (systolic blood pressure [BP] > 170 mmHg or diastolic BP > 105 mmHg) despite optimal medical management\r\n* Major surgery =< 4 weeks of registration
Have uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg).
Resting systolic blood pressure (BP) < 100 mmHg
Hypertension defined as systolic BP >= 140 mmHg or diastolic BP >= 90 mmHg despite optimal medical management
No evidence of pre-existing uncontrolled hypertension as documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart; the baseline systolic BP readings must be =< 150 mm Hg, and the baseline diastolic BP readings must be =< 90 mm Hg
Poorly-controlled hypertension as defined blood pressure (BP) > 150/100 mmHg, or systolic (S) BP > 180 mmHg when diastolic (D) BP < 90 mmHg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment
Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
Blood pressure (BP) > 140 mmHg (systolic) and > 90 mmHg (diastolic); initiation or adjustment of BP medication is permitted prior to registration provided that the average of three BP readings at a visit prior to registration is < 140/90 mmHg
Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 150/90 mm Hg)
Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
Systolic blood pressure (BP) > 150 mmHg or diastolic BP > 100 mmHg.
Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 150/90 mm Hg)
uncontrolled hypertension (systolic BP ? 139 mmHg or diastolic BP ? 89 mmHg) at screening, despite optimal antihypertensive therapy,
Severe hypertension (diastolic BP > 100 on medication)
Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Subjects with uncontrolled hypertension (systolic blood pressure [BP] >180 mmHg or diastolic BP >100 mmHg) at screening are excluded. Subjects requiring 2 or more medications to control hypertension are eligible with Medical Monitor approval.
Patients with a history of hypertension MUST have hypertension adequately controlled (blood pressure [BP] < 140/90) with appropriate anti-hypertensive therapy or diet prior to study entry; Note: To be eligible a subject must have an average of BP below 140/90 based on 3 separate measures; if the subject has a record of BP recordings taken at home, =< 20% of BPs taken should have numbers > 140/90
Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; initiation or adjustment of BP medication is permitted prior to study entry provided that the average of three BP readings at a visit prior to enrollment is less than 140/90 mmHg
Uncontrolled hypertension (systolic blood pressure [sBP] > 150 mmHg and/or diastolic BP > 100 mmHg, found on two consecutive measurements separated by a one week period of time despite adequate medical support)
Blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; initiation or adjustment of BP medication is permitted prior to study entry provided that the average of three BP readings on baseline assessment prior to enrollment is less than 140/90 mmHg
Uncontrolled hypertension defined as systolic blood pressure (BP) >= 140 mmHg or diastolic BP >= 90 mmHg with or without antihypertensive medication, based on a mean of 3 measurements at approximately 2-minute intervals
Significant co-morbidity that could affect the safety or evaluability of participants, specifically including: \r\n* Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy; note that this may be better established with home blood pressure (BP) readings than with clinic visit results; note further that this is NOT a criterion related to particular BP results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes; the intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, NOT to exclude patients who may be hypertensive acutely; there are no absolute criteria for BP readings with respect to eligibility (as determined by treating physician)\r\n* Uncontrolled diabetes mellitus, defined as: hemoglobin (Hgb) A1c > 8.5%; or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation; or more than 1 glucose excursion to > 300 mg/dL in prior two months--unless clearly iatrogenic and the cause has been eliminated \r\n* Lung disease requiring supplemental oxygen \r\n* Known chronic liver disease causing either fibrosis or synthetic dysfunction \r\n* Known human immunodeficiency virus (HIV) infection \r\n* Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care
Uncontrolled hypertension (BP ?150/95 mmHg despite medical therapy)
Uncontrolled hypertension (blood pressure [BP] > 100 diastolic despite treatment with maximum doses of at least 3 simultaneous or concurrent antihypertensives over a 2-month period)
Severe hypertension (diastolic blood pressure [BP] > 100 on medication)
Uncontrolled hypertension (systolic blood pressure [BP] ? 160 millimeters of mercury [mmHg] or diastolic BP ? 95 mmHg).
Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Mean arterial blood pressure (BP) of less than 70 mmHg.
Patients must have resting blood pressure (BP) no greater than 140 mmHg (systolic) or 90 mmHg (diastolic) for eligibility; initiation or adjustment of BP medication is permitted prior to study entry
Uncontrolled hypertension despite appropriate medical therapy (blood pressure [BP] of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit); note: patients may be rescreened after adjustment of antihypertensive medications
Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg) despite medical treatment; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertension treatment
Subjects must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; initiation or adjustment of BP medication is permitted prior to study entry provided that the average of three BP readings at the time of enrollment is =< 140/90 mmHg
Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; initiation or adjustment of BP medication is permitted prior to study entry provided that the BP reading prior to enrollment is no greater than 140/90 mmHg
Uncontrolled hypertension, defined as systolic BP >140 or diastolic >90 despite therapy.
Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
No uncontrolled hypertension (BP >150/100mmHg despite full doses of 1 anti-hypertensive medication).
Baseline arterial blood pressure (BP) >= 140/90 mmHg, despite pharmacologic treatment with antihypertensive agents; if the arterial BP measurements at screening are >= 140/90 mmHg in a patient not on pharmacologic treatment for hypertension (HTN), we will initiate pharmacologic therapy and reassess the parameters after 1 week; at that time, patient will be eligible for enrollment on the study if arterial BP is found < 140/90 mmHg on antihypertensive therapy
Patients with uncontrolled hypertension (defined as sustained stage 2 hypertension, i.e., systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg) with or without medical therapy
Poorly controlled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg) on three or more readings in the past 12 months
Severe hypertension (diastolic BP > 100 on medication)
All patients must also have 3 pre-op blood pressures (BP) to average for determining individual perioperative BP goal; it is preferred to utilize office visit BP's to reduce \whitecoat\ effect seen the morning of surgery
Uncontrolled hypertension (systolic blood pressure [BP] > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.
Systolic/diastolic blood pressure (BP) greater than or equal to 160/100, or below 90/50 (one re-screen allowed)
Severe hypertension (diastolic BP > 100 on medication)
Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg)
Uncontrolled hypertension, blood pressure (BP) > 150/100 mmHg; patients with elevated BP may enroll once BP is corrected