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a |
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b/clusters/3009knumclusters/clust_135.txt |
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1 |
History of thromboembolic or cerebrovascular events ? 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli |
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2 |
Patients with current deep vein thrombosis or deep vein thrombosis within the past 6 months are not eligible |
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3 |
Patients with a history of any arterial thrombotic event within the past 6 months; this includes angina (stable or unstable), myocardial infarction (MI), transient ischemic attack (TIA), or cerebrovascular accident (CVA) |
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4 |
The patient has experienced any arterial thrombotic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment |
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5 |
Angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism , pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within 6 months prior to randomization. Deep venous thrombosis within 3 months prior to randomization unrelated to a central venous catheter, unless the patient is anti-coagulated without the use of warfarin for at least 2 weeks prior to randomization. In this situation, low molecular weight heparin is preferred |
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6 |
STEP I: Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation |
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7 |
Patient history: patients who have any of the following are NOT eligible:\r\n* Central nervous system (CNS): Symptomatic, untreated, or uncontrolled brain metastases present\r\n* Heme: Active bleeding or bleeding diathesis\r\n* Gastrointestinal (GI):\r\n** Abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to registration\r\n** Acute GI bleed within 28 days of registration\r\n* Diabetes mellitus: Patients with diabetes mellitus with inadequate control, based on either a glycosylated hemoglobin (Hgb A1c) of > 7.0 or fasting blood glucose above or equal to 130 mg/dL\r\n* Cardiac and vascular disorders:\r\n** History of congenital long QT syndrome or torsades de pointes\r\n** Any arrhythmia that is currently not rate-controlled (rate between 60 and 100)\r\n** Prolongation of corrected QT interval via Fridericia’s formula (QTcF) > 480 msec\r\n** Ongoing unstable angina\r\n** Symptomatic peripheral vascular disease\r\n** Arterial thrombosis within 28 days of registration including transient ischemic attack (TIA), cerebrovascular accident (CVA), myocardial infarction (MI)\r\n** Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) must be on a stable dose of anticoagulation for 14 days prior to registration\r\n** Uncontrolled hypertension, defined as blood pressure (BP) > 140/90\r\n** Multi gated acquisition scan (MUGA) with ejection fraction (EF), 50% or echocardiogram (echo) with low EF\r\n** Class III or IV congestive heart failure (CHF) within 28 days of registration |
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8 |
Subjects with any of the following cardiovascular conditions within the past 6 months\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Cardiac arrhythmia\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible |
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9 |
History of transient ischemic attack (TIA), cerebrovascular accident (CVA), gastrointestinal (GI) perforation or arterial thrombotic event within 6 months prior to randomization or symptomatic peripheral ischemia |
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10 |
A history of cardiovascular diseases: unstable angina, myocardial infarction, or known congestive heart failure class IIIV within the preceding 12 months; cerebrovascular accident or transient ischemic attack within the preceding 3 months, pulmonary embolism within the preceding 2 months |
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11 |
Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, PTCA or CABG within the past 6 months. |
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12 |
Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) within the past 6 months prior to study enrollment are NOT eligible for participation |
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13 |
Patients with a history of any one or more of the following thromboembolic events within the past 6 months prior to study enrollment are NOT eligible for participation: \r\n* Pulmonary embolism\r\n* Untreated deep venous thrombosis (DVT)\r\n** Subjects with recent DVT who have been therapeutically coagulated for at least 6 weeks ARE eligible |
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14 |
Cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months\r\n* Note: subjects with recent DVT who have been therapeutically coagulated for at least 6 weeks are eligible |
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15 |
History of stroke or transient ischemic attack |
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16 |
Subjects with a history of venous thrombosis within the past 3 months |
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17 |
Subjects with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 6 months |
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18 |
History of a major thromboembolic event =< 6 months prior to randomization, including cerebrovascular accident, transient ischemic attack (TIA), myocardial infarction, symptomatic pulmonary embolism (PE) or untreated deep venous thrombosis (DVT), or coronary artery bypass graft surgery; NOTE: Subjects with recent DVT or asymptomatic PE who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible |
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19 |
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 757 |
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20 |
History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 3 months. |
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21 |
History of stroke or transient ischemic attack within the previous 6 months |
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22 |
History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1 |
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23 |
Any of the following cardiovascular history in the past 6 months: myocardial infarction, unstable angina, coronary/ peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, symptomatic bradycardia, requirement for anti-arrhythmic medication. |
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24 |
History of pulmonary embolism within 6 months prior to the first dose of ALRN-6924 or untreated DVT (deep vein thrombosis) |
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25 |
Patients with a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 3 months prior to registration |
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26 |
Patients who have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment |
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27 |
Have had a prior thrombotic event (e.g., pulmonary embolism, deep vein thrombosis) or are currently receiving therapeutic or prophylactic doses of anticoagulants. |
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28 |
Recent serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI). |
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29 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study registration |
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30 |
Subjects with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or, within 6 months of the first date of treatment on this study, history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage. |
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31 |
Subject has a history of unexplained loss of consciousness or transient ischemic attack within 12 months of treatment start |
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32 |
Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\r\n* Any history of myocardial infarction\r\n* Any history of clinically significant (as determined by the treating physician) atrial arrhythmia\r\n* Any history of ventricular arrhythmia\r\n* Any history of cerebrovascular accident or transient ischemic attack (TIA)\r\n* Any history of peripheral arterial occlusive disease requiring revascularization\r\n* Unstable angina within 6 months prior to enrollment\r\n* Congestive heart failure within 6 months prior to enrollment\r\n* Venous thromboembolism including deep venous thrombosis or pulmonary embolism within 6 months prior to enrollment\r\n* Unacceptable screening baseline cardiovascular assessment:\r\n** Baseline multi gated acquisition scan (MUGA) (to be done within 30 days of registration) or echocardiogram demonstrating left ventricular ejection fraction (LVEF) < 50 %\r\n** Corrected QT (QTc) >= 480 msec on screening electrocardiogram (ECG) (using the QTc Fridericia [QTcF] formula) |
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33 |
Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to:\r\n* Deep vein thrombosis\r\n* Pulmonary embolism\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Peripheral arterial ischemia > grade 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.03) |
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34 |
History of arterial thrombotic disease, specifically including, but not restricted to: \r\n* Myocardial infarction or unstable angina\r\n* Cerebrovascular event (CVA) or transient ischemic attack (TIA)\r\n* Peripheral vascular disease or claudication |
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35 |
History of venous thromboembolism (e.g. deep venous thrombosis or pulmonary embolism) within 6 months of study entry; Note: participants enrolled after this window must be on appropriate therapeutic anticoagulation |
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36 |
No history of arterial thrombotic events such as myocardial infarction (MI), unstable angina pectoris or any ischemic or hemorrhagic cerebrovascular accident (CVA) within past 6 months |
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37 |
Participants with history of pulmonary embolism, deep vein thrombosis (DVT), or vascular access related thrombosis will be allowed on study provided they are receiving adequate anticoagulation at a stable dose at the time of study entry |
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38 |
Any of the following in the previous 6 months:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Coronary/peripheral artery bypass graft\r\n* Symptomatic congestive heart failure\r\n* Cerebrovascular accident\r\n* Transient ischemic attack\r\n* Symptomatic pulmonary embolism |
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39 |
Patients with history or evidence upon physical examination of central nervous system (CNS) disease; seizures not controlled with standard medical therapy; any brain metastases; or history of cerebral vascular accident (CVA), transient ischemic attack (TIA), or subarachnoid hemorrhage within 6 months of the first date of treatment on this study; patients diagnosed with primary brain tumors within the last three years are also excluded |
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40 |
History of deep vein thrombosis and/or pulmonary embolus within 3 months of study entry |
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41 |
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism. |
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42 |
History of thromboembolic or cerebrovascular events ? 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli. |
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43 |
Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack |
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44 |
History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port of catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 3 months prior to enrollment |
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45 |
History of any arterial thromboembolic event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina within 6 months prior to enrollment |
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46 |
History of blood clots, pulmonary embolism, or deep vein thrombosis unless on adequate anticoagulant therapy as determined by the treating investigator (subject must be on stable dose for 2 weeks). |
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47 |
History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable |
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48 |
Patients will be excluded if any of the following are present, evidence of active bleeding, intratumoral hemorrhage, or bleeding diathesis; History (within 6 months prior to study enrollment) of arterial thromboembolic events, including transient ischemic attack (TIA) or cerebrovascular accident (CVA); history (within 6 months prior to study enrollment) of pulmonary embolism, deep venous thrombosis (DVT), or other venous thromboembolic event; history of clinically significant bleeding within 6 weeks prior to study enrollment. |
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49 |
Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures |
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50 |
History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable |
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51 |
Known history of stroke or cerebrovascular accident within 6 months before enrollment. |
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52 |
History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to initiation of study treatment |
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53 |
No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible \r\n* Patients who have experienced a deep venous thrombosis or pulmonary embolus within the past 6 months must be on stable therapeutic anticoagulation to be enrolled to this study |
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54 |
Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism. |
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55 |
History of stroke or transient ischemic attack within 6 months prior to registration |
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56 |
History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 3 months Infection requiring intravenous antibiotics within 1 week of study enrollment (day 1) |
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57 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, deep vein thrombosis or pulmonary embolus within 6 months of informed consent |
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58 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment within 6 months of informed consent |
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59 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment within 6 months of informed consent |
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60 |
History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism |
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61 |
History of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 6 months |
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62 |
Patient must not have any thromboembolic event (deep vein thrombosis or pulmonary embolism) less than 3 weeks prior to enrollment |
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63 |
cerebrovascular accident, including transient ischemic attacks within the past 6 months. |
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64 |
No history of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases |
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65 |
History of thromboembolic events (including both pulmonary embolism and deep venous thrombus but not including tumor thrombus) within the last 6 months |
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66 |
Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to Cycle 1/Day 1 (C1/D1) unless adequately treated and considered stable |
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67 |
Known active brain or central nervous system metastasis, or seizures requiring anticonvulsant treatment, cerebrovascular accident, or transient ischemic attack (< 6 months prior to enrollment) |
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68 |
History of stroke or transient ischemic attack within 6 months prior to day 1 |
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69 |
Recent (< 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction |
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70 |
Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization |
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71 |
Thrombotic events (pulmonary embolism; deep venous thrombosis) within 6 month prior to start of therapy |
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72 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) or deep venous thrombosis (DVT) within 6 months of informed consent\r\n* Tumor or bland thrombus in hepatic vasculature is not a contraindication provided hepatic function criteria are met |
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73 |
Have been treated for a deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if medically indicated per physician discretion). |
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74 |
Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack |
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75 |
Significant thrombotic or embolic events within 4 weeks prior to study day 1; significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack (TIA); catheter-related thrombosis is not a cause for exclusion; diagnosis of deep vein thrombosis or pulmonary embolism is allowed if it occurred > 4 weeks prior to study day 1 and the patient is asymptomatic and stable on anti-coagulation therapy |
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76 |
Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\r\n* Cardiovascular disorders:\r\n** Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment\r\n** Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias\r\n** Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose\r\n* Any history of congenital long QT syndrome\r\n* Presence of a non-healing wound\r\n* Other clinically significant disorders that would preclude safe study participation including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, psychiatric conditions with active suicidal ideation within the past year; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration and, in the judgment of the investigator, would make the patient inappropriate for entry into this study |
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77 |
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment. |
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78 |
History of stroke or transient ischemic attack within 6 months of the randomization |
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79 |
Thromboembolic events and/or bleeding disorders ? 14 days (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) prior to the first dose of study drug |
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80 |
History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1 |
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81 |
Patients unwilling to take deep vein thrombosis (DVT) prophylaxis. |
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82 |
History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment. |
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83 |
Any of the following within 6 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack |
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84 |
History of arterial thromboembolic event in past 6 months (including cerebrovascular accident [CVA], myocardial infarction [MI]) |
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85 |
Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness). |
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86 |
Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to enrollment |
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87 |
Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to Cycle 1/Day 1 (C1/D1) unless adequately treated and considered stable |
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88 |
Any of the following within 6 months before the enrollment:\r\n* Unstable angina pectoris;\r\n* Clinically-significant cardiac arrhythmias;\r\n* Stroke (including transient ischemic attack [TIA], or other ischemic event);\r\n* Myocardial infarction;\r\n* Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter [eg, vena cava filter] are not eligible for this study) |
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89 |
History or presence within the last 3 months of Deep Vein Thrombosis (DVT) or a pulmonary embolism (PE);- Uncontrolled leptomeningeal disease; |
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90 |
Ischemic cerebrovascular event, including transient ischemic attack and artery, revascularization procedures. |
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91 |
Cerebrovascular disease manifested as prior stroke at any time or transient ischemic attack (TIA) in the 12 months prior to initiation of therapy |
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92 |
History of ischemic stroke within 6 months prior to enrollment. |
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93 |
have a history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism or retinal vein thrombosis, unless currently on anticoagulant therapy; |
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94 |
Absence of the following in the previous 6 months:\r\n* Myocardial infarction;\r\n* Unstable angina pectoris;\r\n* Clinically-significant cardiac arrhythmias;\r\n* Stroke (including transient ischemic attack [TIA], or other ischemic event);\r\n* Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter [eg, vena cava filter] are not eligible for this study) |
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95 |
Cerebral vascular accident (CVA) or transitory ischemic attack (TIA) in the year before enrollment, or presence of residual symptoms from CVA that happened more than a year before |
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96 |
Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment |
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97 |
Subject has active or history of deep vein thrombosis (DVT) |
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98 |
History of a venous thromboembolic event, cerebrovascular accident (CVA), hepatic impairment, or heart failure |
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99 |
Patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis |
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100 |
FOR ALL PHASES (Ib AND II): Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study medication |
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101 |
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months |
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102 |
History of hemorrhagic or ischemic stroke within the last 6 months |
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103 |
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection; any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism |
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104 |
Subjects diagnosed with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 3 months of start of study treatment |
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105 |
Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to registration. |
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106 |
Any history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within the past 12 months prior to registration. |
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107 |
Thrombotic, embolic, venous or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months of informed consent |
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108 |
Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or venous pulmonary embolism within 6 months before the start of study treatment; venous thrombotic events such as deep vein thrombosis within 3 months before the start of study treatment |
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109 |
History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment |
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110 |
Any of the following within 6 months before the first dose of study treatment:\r\n* Unstable angina pectoris\r\n* Clinically-significant cardiac arrhythmias\r\n* Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n* Myocardial infarction\r\n* Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study) |
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111 |
Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug. |
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112 |
Venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) within 3 months before the first dose of study drug. Patients with venous thrombotic events ?3 months before the first dose of study drug on stable anticoagulation therapy are eligible. |
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113 |
Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures. |
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114 |
Thromboembolic event (e.g., deep vein thrombosis [DVT] and pulmonary embolism [PE]) ? 4 weeks of C1D1. |
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115 |
History of stroke or transient ischemic attack within 6 months prior to registration |
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116 |
Has a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period |
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117 |
History of prior cerebrovascular event, (including transient ischemic attack) within 6 months of start of screening |
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118 |
Any of the following conditions =< 6 months prior to registration:\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Serious or unstable cardiac arrhythmia\r\n* Admission for unstable angina or myocardial infarction\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation =< 30 days\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease |
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119 |
Any history of cerebrovascular accident or transient ischemic attack |
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120 |
Arterial thromboembolic event including, but not limited to, myocardial infarction, transient ischemic attack, or cerebrovascular accident within 6 months of enrollment |
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121 |
Prior or concurrent deep vein thrombosis or pulmonary embolism |
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122 |
History of any of the following:\r\n* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)\r\n* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial within 6 months prior to randomization\r\n* Venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks) within 6 months prior to randomization\r\n* Clinically significant ventricular arrhythmias within 6 months prior to randomization |
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123 |
Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic, attacks, deep vein thrombosis (DVT) within the past 6 months |
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124 |
Within the past 6 months, has had any of the following: pleural effusion, myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack |
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125 |
History of arterial thrombosis; patients with history of deep vein thrombosis (DVT) are eligible as long as they have received or are receiving appropriate anticoagulation therapy |
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126 |
Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization |
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127 |
Patients with documented deep venous thrombosis or pulmonary embolism within the past 3 months |
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128 |
Significant arterial or venous thromboembolic disease or vascular disorders within 6 months prior to administration of first dose of study drug, including by not limited to:\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Peripheral ischemia > grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)\r\n* Arterial thrombotic event |
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129 |
Patients who have a history of deep vein thrombosis or pulmonary embolus and are stable on anticoagulation for > 1 month are eligible |
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130 |
Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack |
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131 |
SORAFENIB\r\n* Major surgery, open biopsy, or significant traumatic injury within 30 days\r\n* Non-healing wound, ulcer, or bone fracture\r\n* Thrombotic or embolic venous or arterial events, such as cerebrovascular accident, including transient ischemic attacks, arterial thrombosis, deep vein thrombosis and pulmonary embolism within the past 6 months\r\n* Upper Extremity/Line associated DVTs which are adequately treated (line removed and/or patient anticoagulated) are eligible\r\n* Uncontrolled hypertension\r\n* Active bleeding during screening\r\n* Hypersensitivity to sorafenib |
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132 |
Significant thrombotic or embolic events within 3 months prior to study day 1; significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack (TIA); catheter-related thrombosis is not a cause for exclusion; diagnosis of deep vein thrombosis or pulmonary embolism is allowed if the patient is clinically stable and has completed or is on stable anti-coagulation therapy |
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|
133 |
Have clinically significant heart disease as evidenced by severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization |
|
|
134 |
PHASE I AND II SCLC AND UROTHELIAL CARCINOMA EXPANSION COHORT: History of stroke, transient ischemic attack (TIA), or myocardial infarction, within 6 months prior to C1D1 |
|
|
135 |
Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack |
|
|
136 |
History of deep vein thrombosis or pulmonary embolism within 6 month of anticipated starting of axitinib |
|
|
137 |
Any of the following within 6 months of registration: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism; no QTc interval > 480 msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or torsade de pointes |
|
|
138 |
The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 3 months prior to randomization |
|
|
139 |
The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment |
|
|
140 |
History of any of the following:\r\n* Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)\r\n* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization\r\n* Any condition that in the opinion of the investigator, would preclude participation in this study |
|
|
141 |
History of stroke or transient ischemic attack within 3 months prior to cycle 1, day 1 |
|
|
142 |
Patients with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of\r\nstudy enrollment) |
|
|
143 |
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before enrollment |
|
|
144 |
Any documented history of clinically identifiable thrombotic, embolic, venous, or arterial events such as cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism within 6 months prior to initiating study treatment\r\n* Note: Patients with an asymptomatic catheter-related thrombus or a tumor-associated thrombus of locally-involved vessels or with incidental asymptomatic filling defects identified on imaging are not excluded |
|
|
145 |
Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism |
|
|
146 |
History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism (applicable to combination part only). |
|
|
147 |
CAPMATINIB EXCLUSION CRITERIA: Any of the following in the past 6 months prior to screening:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Clinically significant cardiac arrhythmias\r\n* Cerebrovascular accident or transient ischemic attack\r\n* Coronary/peripheral artery bypass graft |
|
|
148 |
CERITINIB EXCLUSION CRITERIA: Any of the following in the past 6 months prior to screening:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Clinically significant cardiac arrhythmias\r\n* Cerebrovascular accident or transient ischemic attack\r\n* Coronary/peripheral artery bypass graft |
|
|
149 |
REGORAFENIB EXCLUSION CRITERIA: Any of the following in the past 6 months prior to screening:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Clinically significant cardiac arrhythmias\r\n* Cerebrovascular accident or transient ischemic attack\r\n* Coronary/peripheral artery bypass graft |
|
|
150 |
ENTRECTINIB EXCLUSION CRITERIA: Any of the following in the past 6 months prior to screening:\r\n* Myocardial infarction\r\n* Severe/unstable angina\r\n* Clinically significant cardiac arrhythmias\r\n* Cerebrovascular accident or transient ischemic attack\r\n* Coronary/peripheral artery bypass graft |
|
|
151 |
History or presence of serious hemorrhage , hemoptysis or hematemesis within 3 months or a thromboembolic event (including Deep Vein Thrombosis (DVT), stroke and/or transient ischemic attack) within 6 months; Patients with squamous Non Small Cell Lung Cancer (NSCLC) should be excluded. |
|
|
152 |
Cerebrovascular event (transient ischemic attack, stroke or CNS bleeding) within the last 12 months. |
|
|
153 |
Myocardial infarction, uncontrolled angina, congestive heart failure, or cerebrovascular accident within previous 6 months; subjects with a history of deep vein thrombosis or pulmonary embolism, at provider discretion |
|
|
154 |
The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism, including portal venous thrombosis (venous port or catheter thrombosis, incidental pulmonary embolism diagnosed on imaging studies or superficial venous thrombosis are not considered significant) during the 3 months prior to randomization |
|
|
155 |
The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment |
|
|
156 |
Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE grade >= 2, symptomatic congestive heart failure, or cerebrovascular accident excluding transient ischemic attack |
|
|
157 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment |
|
|
158 |
History of any of the following:\r\n* Seizure or known condition that may predispose to seizure (e.g., prior stroke within 1 year of randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)\r\n* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization |
|
|
159 |
Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months of study treatment initiation |
|
|
160 |
Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack |
|
|
161 |
Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism |
|
|
162 |
Any history of myocardial infarction (MI), unstable angina, cerebrovascular accident, or Transient Ischemic Attack (TIA) |
|
|
163 |
Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 6 months prior to enrollment |
|
|
164 |
History of deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment |
|
|
165 |
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nHistory of cerebrovascular accident, transient ischemic attack within 1 year prior to study enrollment |
|
|
166 |
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nHistory of cerebrovascular accident, transient ischemic attack within 1 year prior to study enrollment |
|
|
167 |
Any documented history of thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism within 6 months prior to initiating study treatment\r\n* Note: patients with a tumor-associated thrombus of locally-involved vessels should not be excluded from participating in the study |
|
|
168 |
Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
169 |
Cerebrovascular accident or transient ischemic attack |
|
|
170 |
History of stroke or transient ischemic attack within six months |
|
|
171 |
loss of consciousness or transient ischemic attack within 12 months of randomization |
|
|
172 |
Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery (CABG) within the past 6 months; deep venous thrombosis within 6 months, unless the patient is anticoagulated without the use of warfarin for at least 2 weeks; in this situation, low molecular weight heparin is preferred |
|
|
173 |
History of deep venous thrombosis and pulmonary embolism (Phase 1b). |
|
|
174 |
History of deep venous thrombosis (DVT) or pulmonary embolism (PE) |
|
|
175 |
Patients with stroke or transient ischemic attack (TIA) within 90 days prior to enrollment; or peripheral vascular disease requiring intervention within the 90 days prior to enrollment; or any known hemodynamically significant lesion or embolic plaque |
|
|
176 |
Cerebrovascular accident at any time in the past, transient ischemic attack, deep venous thrombosis or pulmonary embolism in the past 6 months |
|
|
177 |
Arterial thrombotic or embolic events such as a myocardial infarction or cerebrovascular accident (including transient ischemic attacks) within the 6 months prior to initiation of treatment; incidental clinically insignificant embolic phenomena that do not require anti-coagulants are not excluded; also, tumor-associated thrombus of locally-involved vessels does not count as an exclusion criterion |
|
|
178 |
History of arterial thromboembolic events or symptomatic pulmonary embolism within the past 6 months |
|
|
179 |
Patients with any history of arterial thromboembolic disease; any patient with a history of myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina or peripheral vascular disease will not be eligible |
|
|
180 |
Patients with history of recurrent venous thromboembolism (deep venous thrombosis or pulmonary embolism) or history of venous thromboembolism within 6 months prior to registration on study will not be eligible |
|
|
181 |
Patients with a recent history of deep vein thrombosis or pulmonary embolus, in the six months prior to enrollment are not eligible for this study |
|
|
182 |
History of cerebrovascular accident including transient ischemic attack, pulmonary embolism (including asymptomatic or previously treated pulmonary embolism [PE]), or untreated deep venous thrombosis within the past 6 months; patients with recent deep vein thrombosis (DVT) who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible |
|
|
183 |
History of stroke or transient ischemic attack within 6 months prior to study enrollment |
|
|
184 |
History of any of the following within the last 6 months prior to study entry:\r\n* Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures\r\n* Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures\r\n* Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)\r\n* Placement of a pacemaker for control of rhythm\r\n* Pulmonary embolism |
|
|
185 |
Recent venous thrombosis within 4 weeks prior to study registration; patients at high risk for thrombotic events due to inherited risk factors (i.e. factor V Leiden) or deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 12 months should be on secondary prophylaxis with anti-coagulant therapy (i.e. warfarin or low molecular weight heparin) prior to enrollment |
|
|
186 |
Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug. |
|
|
187 |
History of stroke or transient ischemic attack within 6 months prior to day 1 |
|
|
188 |
Severe cardiovascular disease within 6 months, including myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebro-vascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias, uncontrollable hypertension or QT prolongation syndrome |
|
|
189 |
Patients with any of the following within 6 months of enrollment: deep vein thrombosis, pulmonary embolus, myocardial infarction, cerebrovascular accident, unexplained loss of consciousness |
|
|
190 |
Deep vein thrombosis or pulmonary embolism within 3 months of study entry |
|
|
191 |
Arterial thromboembolic or embolic events such as myocardial infarction, cerebrovascular accident, including transient ischemic attacks within 6 months prior to first study treatment |
|
|
192 |
Sorafenib\r\n* Major surgery, open biopsy, or significant traumatic injury within 30 days\r\n* Non-healing wound, ulcer, or bone fracture\r\n* Thrombotic or embolic venous or arterial events, such as cerebrovascular accident, including transient ischemic attacks, arterial thrombosis, deep vein thrombosis and pulmonary embolism within the past 6 months\r\n* Uncontrolled hypertension\r\n* Active bleeding during screening\r\n* Hypersensitivity to sorafenib |
|
|
193 |
Patients with history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study |
|
|
194 |
History (within the last 3 months) or presence of stroke/cerebrovascular accident |
|
|
195 |
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 anti-coagulating agents for at least 6 weeks are eligible |
|
|
196 |
Thrombolic or embolic events (except deep vein thrombosis [DVT] or pulmonary embolus) such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
197 |
History of any of the following:\r\n* Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 6 months of cycle 1 day 1, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)\r\n* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to first dose of study drug; venous thrombotic events within 6 months are permitted IF they are not attributed to prostate cancer (in the opinion of the treating physician) |
|
|
198 |
Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose. |
|
|
199 |
Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, =< 6 months prior to randomization |
|
|
200 |
History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 3 months prior to randomization |
|
|
201 |
Patients must not have been previously diagnosed with a deep venous or arterial thrombosis (including pulmonary embolism), and must not have a known thrombophilic condition |
|
|
202 |
Patients with symptomatic congestive heart failure, unstable angina or myocardial infarction, coronary/peripheral artery bypass graft or repair, cerebrovascular accident or transient ischemic attack in the 12 months prior to randomization; or deep vein thrombosis or pulmonary embolism in the 6 months prior to randomization |
|
|
203 |
MATCHED RELATED DONOR: Other medical contraindications to stem cell donation (i.e. severe atherosclerosis, autoimmune disease, iritis or episcleritis, deep venous thrombosis, cerebrovascular accident) |
|
|
204 |
Patients with a history of arterial or venous thrombosis |
|
|
205 |
History of transient ischemic attack (TIA) or stroke within 6 months of study entry |
|
|
206 |
Patients with history of deep venous thrombus or pulmonary embolism. Patients who are at increased risk of thrombosis during treatment with lenalidomide including those taking concurrent erythropoietin, darbepoetin or high-dose corticosteroids are also excluded. |
|
|
207 |
History of deep vein thrombosis and/or pulmonary embolism within 4 weeks of enrollment. |
|
|
208 |
Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to Cycle 1/Day 1 (C1/D1) unless adequately treated and considered stable |
|
|
209 |
Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization |
|
|
210 |
History of venous or arterial thrombosis within the preceding year of enrollment |
|
|
211 |
Stroke within 6 months of screening, or transient ischaemic attack (TIA) within 3 months of screening |
|
|
212 |
History of cerebrovascular accident including transient ischemic attack (TIA), myocardial infarction, pulmonary embolism or untreated deep venous thrombosis (DVT), coronary artery bypass graft surgery within 6 months prior to registration; Note: subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible |
|
|
213 |
215 History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 562. |
|
|
214 |
Thrombotic or embolic event within the last 6 months including portal vein thrombosis |
|
|
215 |
Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable. |
|
|
216 |
History of transient ischemic attack within the previous 6 months |
|
|
217 |
Prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study and not currently on systemic anticoagulation |
|
|
218 |
Deep vein thrombosis or pulmonary embolism =< 4 weeks before first dose of protocol-indicated treatment, unless adequately treated and stable |
|
|
219 |
History of unprovoked deep vein thrombosis/pulmonary embolism (DVT/PE) in past twelve (12) months |
|
|
220 |
History of loss of consciousness or transient ischemic attack within twelve (12) months of enrollment |
|
|
221 |
Patients with a history of idiopathic deep venous thrombosis, pulmonary embolus, thrombotic stroke, or arterial thrombosis will be excluded from study; patients with a history of a central venous catheter-associated thrombosis that has completely resolved will be eligible for study but should be monitored for thrombosis |
|
|
222 |
Any of the following: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE grade >= 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, uncontrolled seizures or brain metastases or pulmonary embolism. |
|
|
223 |
Any of the following within 6 months prior to randomization: Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias |
|
|
224 |
History of an ischemic insult in the previous 12 months (myocardial infarction, cerebral vascular accident, ischemic tissue from injury, transient ischemic attack) |
|
|
225 |
History of vascular disease (e.g. deep vein thrombosis, stroke) |
|
|
226 |
History of seizures except for remote with specific etiology which has resolved (ex: alcohol induced seizure); transient ischemic attack (TIA) or cerebrovascular accident (CVA) within last 6 months |
|
|
227 |
Patient has a history of seizures or any condition that may predispose to seizures (e.g., prior cortical stroke, significant brain trauma) at any time in the past and/or a history of loss of consciousness or transient ischemic attack within 12 months of the cycle 1, day 1 visit. |
|
|
228 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment |
|
|
229 |
History of stroke or transient ischemic attack =< 6 months prior to registration |
|
|
230 |
History of loss of consciousness or transient ischemic attack within 12 months prior to enrollment |
|
|
231 |
Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 4 weeks prior to first IMP administration. |
|
|
232 |
Patients with any prior history of arterial thrombosis or symptomatic pulmonary embolism |
|
|
233 |
History of transient ischemic attack (TIA) or cerebrovascular accident (CVA) |
|
|
234 |
Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration |
|
|
235 |
Patients must not have a history of prior stroke, transient ischemic attack (TIA), pulmonary embolism, or untreated deep vein thrombosis\r\n* NOTE: Patients may be eligible if they have received at least 3 months of anticoagulation for a deep vein thrombosis |
|
|
236 |
Any documented history of clinically significant thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism necessitating therapeutic anticoagulation within 6 months prior to initiating study treatment; Note: Patients with a tumor-associated thrombus of locally-involved vessels should not be excluded from participating in the study |
|
|
237 |
History of deep vein thrombosis or pulmonary embolism within 6 months of screening; patients who are currently taking anticoagulation therapy for a prior history (> 6 months from screening) of thrombosis may still be eligible |
|
|
238 |
Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months; Note: Participants with recent DVT who have been treated with therapeutic anti-coagulants for at least 6 weeks are eligible, with the exception of participants being treated with warfarin, which is prohibited on this study; other oral anti-coagulants may be allowed after discussion with overall principle investigator (PI), but short half-life low molecular weight heparins are strongly preferred |
|
|
239 |
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before registration |
|
|
240 |
Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, any brain metastases and/or epidural disease, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment |
|
|
241 |
History of stroke or transient ischemic attack within six months |
|
|
242 |
History of stroke or transient ischemic attack within 6 months prior to Day1 |
|
|
243 |
Patients with a history of seizures, predisposing factors for seizures, including underlying brain injury with loss of consciousness within previous 12 months, transient ischemic attack within previous 12 months, cerebral vascular accident or brain arteriovenous malformation |
|
|
244 |
Patients with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of the study registration |
|
|
245 |
Any of the following conditions =< 6 weeks prior to registration:\r\n* Cerebrovascular accident (CVA)\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting or coronary artery bypass graft surgery\r\n* Untreated pulmonary embolism or untreated deep venous thrombosis (DVT)\r\n* Arterial thrombosis\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system |
|
|
246 |
History of blood clots, pulmonary embolism, or deep vein thrombosis in previous 6 months unless controlled by anticoagulant treatment |
|
|
247 |
Arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or MI within 6 months of study registration |
|
|
248 |
Prior history of a major thrombotic event, such as pulmonary emboli, deep vein thrombosis or stroke, as assessed by the investigator, or history of an asparaginase associated serious hemorrhage or thrombus requiring anticoagulation therapy |
|
|
249 |
Significant thrombotic or embolic events within 3 months prior to study day 1; significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack (TIA); catheter-related thrombosis is not a cause for exclusion; diagnosis of deep vein thrombosis or pulmonary embolism is allowed if it occurred > 3 months prior to study day 1 and the patient has completed or is on stable anti-coagulation therapy |
|
|
250 |
Patients with a history of thrombotic or embolic events within the last six months such as a cerebrovascular accident (including transient ischemic attacks), pulmonary embolism |
|
|
251 |
Patients with evidence of active bleeding, intratumoral hemorrhage, or bleeding diathesis are not eligible:\r\n* History (within 180 days prior to study enrollment) of arterial thromboembolic events, including transient ischemic attack (TIA) or cerebrovascular accident (CVA)\r\n* History (within 180 days prior to study enrollment) of pulmonary embolism, deep vein thrombosis (DVT), or other venous thromboembolic event\r\n* History of hemoptysis within 42 days prior to study enrollment |
|
|
252 |
Ischemic cerebrovascular event, including transient ischemic attack (TIA) and artery revascularization procedures |
|
|
253 |
Any history of seizure; history of loss of consciousness or transient ischemic attack within 12 months of starting the study drug |
|
|
254 |
History of pulmonary embolus and/or substantial deep vein thrombosis |
|
|
255 |
Any history of a venous thromboembolic event (VTE), including deep vein thrombosis\n (DVT) or pulmonary embolism (PE) |
|
|
256 |
Subjects with any of the following cardiovascular conditions within the past 6 months\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Admission for unstable angina\r\n* Myocardial infarction\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible\r\n* Active cardiac arrhythmia (except sinus arrhythmia, atrial fibrillation, asymptomatic premature ventricular contractions [PVCs])\r\n* Ejection fraction < institutional lower limit of normal (LLN) and/or history of cardiomyopathy |
|
|
257 |
Any of the following within 6 months prior to first dose of treatment: myocardial infarction, symptomatic coronary artery disease (severe or unstable angina), artery bypass graft, uncontrolled arrhythmias, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolus |
|
|
258 |
Patients with any of the following cardiovascular conditions within the past 6 months:\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Admission for unstable angina\r\n* Myocardial Infarction\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT), or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Note: a patient who has a history of class III heart failure and is asymptomatic on treatment may be considered eligible for the study |
|
|
259 |
Patients with history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study are ineligible |
|
|
260 |
History of stroke or transient ischemic attack within 6 months prior to study enrollment |
|
|
261 |
History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day |
|
|
262 |
Patients with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks [TIAs]) within 6 months before randomization |
|
|
263 |
Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation |
|
|
264 |
Prior history of cerebrovascular accident or transient ischemic attack. |
|
|
265 |
Subject with a history of loss of consciousness or transient ischemic attack ? 12 months of study drug initiation. |
|
|
266 |
No history of acute arterial thrombotic events within the past 6 months (including cerebrovascular accident [CVA], transient ischemic attack [TIA], myocardial infarction [MI], or unstable angina) |
|
|
267 |
History of arterial thromboembolic events or symptomatic pulmonary embolism within 6 months of study enrollment |
|
|
268 |
The patient has a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered \significant\) during the 3 months prior to first dose of protocol therapy |
|
|
269 |
Patient must have no history of cerebrovascular accident (CVA) within 6 months of randomization |
|
|
270 |
Have experienced any arterial or venothrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 6 months (?6 months) prior to randomization. |
|
|
271 |
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; Note: patients with recent DVT who have been treated with therapeutic anticoagulation agents for at least 6 weeks are eligible as long as their INR is stable and within inclusion criteria above |
|
|
272 |
History of cerebrovascular accident including transient ischemic attack, pulmonary embolism (PE) (including asymptomatic or previously treated PE), or untreated deep venous thrombosis within the past 6 months; patients with deep venous thrombosis (DVT) who are being treated with therapeutic anti-coagulating agents are eligible |
|
|
273 |
History of pulmonary embolism within 6 months prior to the first dose of ALRN-6924 or untreated DVT (deep vein thrombosis) |
|
|
274 |
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism |
|
|
275 |
Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, PTCA or CABG within the past 6 months. Deep venous thrombosis within 6 months, unless the patient is anti-coagulated without the use of warfarin for at least 2 weeks. In this situation, low molecular weight heparin is preferred. |
|
|
276 |
Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade ?2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism. |
|
|
277 |
No clinically significant cardiovascular disease\r\n* Patients with a history of hypertension must be well controlled (< 150/90) on a regimen of antihypertensive therapy\r\n* History of arterial thrombotic events within the past 6 months, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina, or angina requiring surgical or medial intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block), significant vascular disease (i.e., aortic aneurysm, history of aortic dissection) are not eligible\r\n* Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation\r\n* No current New York Heart Association classification II, III, or IV congestive heart failure |
|
|
278 |
Has had within the past 6 months the occurrence of one or more of the following events: myocardial infarction, cerebrovascular accident, deep vein thrombosis, pulmonary embolism, hemorrhage (NCI CTCAE Grade 3 or 4), chronic liver disease (meeting criteria for Child-Pugh Class B or C), or organ transplantation. |
|
|
279 |
History of stroke or transient ischemic attacks within 6 months prior to study enrolment. |
|
|
280 |
History of thromboembolic events and/or bleeding disorders ? 14 days (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) prior to the first dose of study drug |
|
|
281 |
Cerebrovascular accident or transient ischemic attack |
|
|
282 |
Has a history of deep vein thrombosis or pulmonary embolism within 6 months of screening. |
|
|
283 |
Subject has history of loss of consciousness or transient ischemic attack within 12 months prior to day 1. |
|
|
284 |
Any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of Grade greater than or equal to (>/=) 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident including transient ischemic attack |
|
|
285 |
History of cerebrovascular accident within the past 6 months |
|
|
286 |
History of untreated deep venous thrombosis |
|
|
287 |
Patients must have international normalized ratio (INR) =< 1.2 within 14 days prior to registration; patients must not be receiving warfarin for therapeutic use, have history of cerebrovascular accident (CVA), history of transient ischemic attack (TIA) requiring intervention or treatment, pre-existing carotid artery disease requiring intervention or treatment, or current use of megestrol acetate (use within 10 days of registration) |
|
|
288 |
Patients are excluded if they have a history of stroke or transient ischemic attack within 6 months prior to randomization |
|
|
289 |
Has had a deep venous thrombosis (DVT) or pulmonary embolism within the 3 months prior to study enrollment. NOTE: Subjects with a history of a DVT or pulmonary embolism >3 months prior to study enrollment who are on anticoagulation therapy with low molecular weight heparin are eligible for this study. |
|
|
290 |
Arterial or venous thrombotic or embolic events such as cerebral vascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before randomization (except for adequately treated catheter-related venous thrombosis occurring within 6 months before randomization). |
|
|
291 |
Known history of stroke or cerebrovascular accident within 6 months prior to enrollment |
|
|
292 |
Recent (=< 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction |
|
|
293 |
have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period |
|
|
294 |
Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first dose of study drug. |
|
|
295 |
The subject has a history of loss of consciousness, cerebrovascular accident, or transient ischemic attack within 12 months before the Day 1 visit. |
|
|
296 |
Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, PTCA or CABG within the past 6 months. Deep venous thrombosis within 6 months unless the patient is anticoagulated without the use of warfarin for at least 2 weeks. In this situation, low molecular weight heparin is preferred. |
|
|
297 |
Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
298 |
History of stroke or transient ischemic attack within 6 months prior to cycle 1, day 1 |
|
|
299 |
History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident (CVA)/stroke or transient ischemic attack (TIA) or sub-arachnoid hemorrhage within =< 6 months prior to the first study treatment |
|
|
300 |
Patients with the following: \r\n* Bleeding diathesis or patients in whom prophylactic antithrombotic therapy is otherwise contraindicated \r\n* Patients with prior deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial thromboembolism \r\n* Patients with ischemic stroke or transient ischemic attack (TIA) |
|
|
301 |
Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures; |
|
|
302 |
Within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. |
|
|
303 |
History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, any brain metastases and/or epidural disease, or history of cerebrovascular accident (cerebrovascular accident [CVA], stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment |
|
|
304 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months of start of study treatment. |
|
|
305 |
Have a history of arterial or venous embolism within 6 months prior to study entry. |
|
|
306 |
History of stroke, deep venous thrombosis (DVT), or transient ischemic attack (TIA) |
|
|
307 |
Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization. |
|
|
308 |
History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months prior to registration |
|
|
309 |
Any history of thrombotic cerebrovascular accident or other arterial thrombosis |
|
|
310 |
Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months prior to the first date of study therapy. |
|
|
311 |
Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
312 |
Previous history of cerebrovascular accident (CVA), transient ischemic attack (TIA), angina pectoris, acute myocardial infarction (MI) or history of recent re-perfusion procedures (e.g. percutaneous transluminal coronary angioplasty [PTCA]), pulmonary embolus or untreated deep vein thrombosis (DVT) within 6 months from day 1 of study drug; NOTE: subjects with recent DVT who have been therapeutically anti-coagulated for at least 6 weeks are eligible |
|
|
313 |
Indicated for radical prostatectomy\r\n* Note: candidates for radical prostatectomy are still eligible even if they have a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation |
|
|
314 |
History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months |
|
|
315 |
Participants with prior history of thromboembolic disease (i.e. deep venous thrombosis [DVT] or pulmonary embolism [PE] within the last six months) |
|
|
316 |
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack |
|
|
317 |
History of stroke or transient ischemic attack within 6 months |
|
|
318 |
History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment. |
|
|
319 |
Known active brain or central nervous system metastasis (less than 1 month out from definitive radiotherapy or surgery), or seizures requiring anticonvulsant treatment, or clinically significant cerebrovascular accident or transient ischemic attack (< 3 months) |
|
|
320 |
History of thromboembolic or cerebrovascular events =< 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli |
|
|
321 |
History of stroke or transient ischemic attack within 6 months prior to beginning treatment. |
|
|
322 |
Known history of stroke or cerebrovascular accident within 6 months prior to enrollment |
|
|
323 |
History of stroke or transient ischemic attack, or other arterial thrombosis =< 12 months prior to randomization |
|
|
324 |
Stroke, transient ischemic attack, arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within the past 6 months |
|
|
325 |
Have a history of deep vein thrombosis, pulmonary embolism, or any other significant venous thromboembolism (venous catheter thrombosis or superficial venous thrombosis not considered \significant\) during the 3 months prior to study enrollment. Participants with venous thromboembolism occurring 3 to 6 months prior to study enrollment are allowed, if being treated with low molecular weight heparin. |
|
|
326 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of study treatment start |
|
|
327 |
History of deep venous thrombosis or migratory thrombophlebitis (Trousseau) |
|
|
328 |
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack |
|
|
329 |
Subject has a history of loss of consciousness or transient ischemic attack within 12 months before the Day 1 visit. |
|
|
330 |
Known history of stroke or cerebrovascular accident within 6 months prior to enrollment |
|
|
331 |
Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, deep vein thrombosis or symptomatic pulmonary embolism. |
|
|
332 |
Known, existing uncontrolled coagulopathy; patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation are eligible IF: they are appropriately anticoagulated and have not had a grade 2 or greater bleeding episode in the 3 weeks before day 1 |
|
|
333 |
Prior history of cerebrovascular accident or transient ischemic attack, or pre-existing carotid artery disease |
|
|
334 |
Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study. |
|
|
335 |
Has a history of an arterial thromboembolic event within the prior six months including cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina. |
|
|
336 |
Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment (patient must be on stable dose for 2 weeks). |
|
|
337 |
Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months |
|
|
338 |
loss of consciousness or transient ischemic attack within 12 months of randomization |
|
|
339 |
The participant experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization. |
|
|
340 |
Subjects with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or, within six months prior to Day 1 of this study, history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage. |
|
|
341 |
History of recurrent thrombosis or any thrombosis within the past 6 months |
|
|
342 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of informed consent |
|
|
343 |
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism =< 6 months prior to randomization |
|
|
344 |
History of blood clots, pulmonary embolism, or deep vein thrombosis unless controlled by anticoagulant treatment. |
|
|
345 |
Participants may not have had a history of a stroke or transient ischemic attack within six months |
|
|
346 |
Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study |
|
|
347 |
Arterial thrombotic events =< 6 months prior to randomization; Note: this includes transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI) |
|
|
348 |
Significant thrombotic or embolic events within 4 weeks prior to study day 1; significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack (TIA); catheter-related thrombosis is not a cause for exclusion; diagnosis of deep vein thrombosis or pulmonary embolism is allowed if it occurred > 4 weeks prior to study day 1 and the patient is asymptomatic and stable on anti-coagulation therapy |
|
|
349 |
History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months |
|
|
350 |
Have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study enrollment (any thrombosis within 2 months of study enrollment must be approved by the protocol chair and/or medical monitor) |
|
|
351 |
Patients must have not have a history of hemorrhagic or ischemic stroke, including transient ischemic attacks and other central nervous system bleeding in the preceding 6 months that were not related to glioma surgery |
|
|
352 |
Patients with prior deep vein thrombosis (DVT) or pulmonary embolism (PE) currently on anticoagulation regimen will be permitted |
|
|
353 |
Patients with a cerebrovascular accident or transient ischemic attack within the past six months |
|
|
354 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism =< 6 months prior to registration |
|
|
355 |
Thrombosis or vascular ischemic events within the last six months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction |
|
|
356 |
History of thromboembolic events (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) ? 2 weeks before the first dose of study drug and/or clinical diffuse intravascular coagulation (DIC) |
|
|
357 |
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication) |
|
|
358 |
Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and who meet any of the following criteria:\r\n* Have been on a stable dose of anticoagulation for < 1 month\r\n* Have had a grade 2, 3 or 4 hemorrhage in the last 30 days\r\n* Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement); NOTE: Patients who have had a venous thromboembolic event but do not meet any of the above three criteria are eligible for participation |
|
|
359 |
Patients with any of the following conditions are excluded:\r\n* Serious or non-healing wound, ulcer, or bone fracture\r\n* History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days of treatment\r\n* Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry\r\n* History of myocardial infarction, ventricular arrhythmia, stable/unstable angina, symptomatic congestive heart failure, coronary/peripheral artery bypass graft or stenting or other significant cardiac disease within 12 months prior to study entry\r\n* Any history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within the past 12 months\r\n* Any episode of atrial fibrillation in the prior 12 months |
|
|
360 |
History of cerebrovascular attack or transient ischemic attack within 6 months prior to the initiation of therapy on this protocol |
|
|
361 |
In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack |
|
|
362 |
In past 6 months: deep vein thrombosis or pulmonary embolism |
|
|
363 |
Stroke or transient ischemic attack |
|
|
364 |
Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study |
|
|
365 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of informed consent |
|
|
366 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment |
|
|
367 |
Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose |
|
|
368 |
Patients with a history of deep venous thromboembolism or pulmonary embolism on treatment with anticoagulation are eligible for the study |
|
|
369 |
Any of the following within the preceding 6 months- myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass, graft, cerebrovascular accident or transient ischemic attack, clinically significant bleeding |
|
|
370 |
Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
371 |
Myocardial infarction and transient ischemic attack or stroke within 6 months prior to enrollment |
|
|
372 |
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. |
|
|
373 |
History of loss of consciousness or transient ischemic attack within 12 months prior to enrollment |
|
|
374 |
History of arterial thrombosis (i.e. stroke) in the past year |
|
|
375 |
Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug |
|
|
376 |
history of cerebrovascular accident (CVA) or transient ischemic attack (TIA), |
|
|
377 |
Any of the following within 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and within 6 months before study drug administration for deep vein thrombosis or pulmonary embolism |
|
|
378 |
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 prior to study treatment are eligible |
|
|
379 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) within 6 months of informed consent |
|
|
380 |
History of arterial thrombosis (i.e. stroke) in the past year |
|
|
381 |
Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to:\r\n* Deep vein thrombosis\r\n* Pulmonary embolism\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Peripheral arterial ischemia > grade 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) |
|
|
382 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) within 6 months of informed consent |
|
|
383 |
No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, myocardial infarction (MI), or unstable angina or angina requiring surgical or medical intervention in 6 months prior to registration; patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible; patients who have experienced a deep venous thrombosis or pulmonary embolus within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 6 weeks prior to enrollment of this study |
|
|
384 |
Evidence of deep vein thrombosis (DVT) or pulmonary embolism (PE) or other known thromboembolic event present during screening period. |
|
|
385 |
Prior history of cerebrovascular accident or transient ischemic attack |
|
|
386 |
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months |
|
|
387 |
History of a stroke or transient ischemic attack within 6 months |
|
|
388 |
History of aortic aneurysm, aortic dissection, angina, myocardial infarction, stroke, transient ischemic attack, or other arterial thrombotic events within 6 months of registration; patients on therapeutic non-coumarin anticoagulation are eligible provided that they are on a stable dose of anticoagulants |
|
|
389 |
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication. |
|
|
390 |
Known history of deep vein thrombosis or pulmonary embolus except in patients where the cause was directly related to foreign body implants, i.e. central venous catheters, portacaths, etc. |
|
|
391 |
Patients with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of study enrollment) |
|
|
392 |
Patient must not have a history of cerebrovascular accident including transient ischemic attack within the past 6 months; patients with recent deep venous thrombosis or pulmonary embolism who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible as long as INR is stable |
|
|
393 |
- History of stroke or transient ischemic attack within 6 months prior to Day 1. |
|
|
394 |
History of significant cerebrovascular disease (i.e. stroke or transient ischemic attack [TIA]) in the past 6 months or ongoing event with active symptoms or sequelae |
|
|
395 |
History of an arterial thrombotic vascular event including cerebrovascular accident (CVA), myocardial infarction (MI), unstable angina, coronary or peripheral arterial bypass graft, or transient ischemic attack (TIA) within 6 months |
|
|
396 |
History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident (CVA)/stroke or transient ischemic attack (TIA) or sub-arachnoid hemorrhage within =< 6 months prior to the first study treatment |
|
|
397 |
Subjects with deep vein thrombosis (DVT) and Pulmonary embolism (PE) within 3 months prior to day 1 treatment |
|
|
398 |
Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) within 6 months of screening |
|
|
399 |
Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of screening |
|
|
400 |
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within 6 months of registration; note: subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks prior to registration and are fully anti-coagulated are eligible |
|
|
401 |
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack |
|
|
402 |
History of cerebrovascular accident, including transient ischemic attack (TIA) |
|
|
403 |
Candidates may have a history of deep vein thrombosis, pulmonary embolism, and/or cerebrovascular accident, or require concomitant systemic anticoagulation, if otherwise deemed to be suitable for RP |
|
|
404 |
Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event |
|
|
405 |
History of cerebral vascular accident (CVA) or transient ischemic attack (TIA) =< 6 months prior to randomization |
|
|
406 |
History of stroke or transient ischemic attack within 6 months prior to day 1 |
|
|
407 |
History of arterial thrombotic events within 6 months before randomization, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 6 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (e.g., claudication with < 1 block) or any other arterial thrombotic event are also ineligible |
|
|
408 |
Prior history of stroke or transient ischemic attack within 6 months prior to day -3 |
|
|
409 |
History or clinical evidence of deep venous thrombosis including pulmonary embolus within 6 months of treatment |
|
|
410 |
History of cerebrovascular accident including transient ischemic attack within the past 12 months |
|
|
411 |
History of pulmonary embolism or deep vein thrombosis (DVT) within the past 6 months |
|
|
412 |
History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; Note: subjects with recent DVT who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible |
|
|
413 |
Cerebrovascular accident within prior 6 months |
|
|
414 |
History of pulmonary embolism or deep venous thrombosis within the past six months of the first dose of study treatment |
|
|
415 |
Subjects with any of the following cardiovascular conditions within the past 6 months:\r\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)\r\n* Cardiac arrhythmia\r\n* Admission for unstable angina\r\n* Cardiac angioplasty or stenting\r\n* Coronary artery bypass graft surgery\r\n* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\r\n* Arterial thrombosis\r\n* Symptomatic peripheral vascular disease\r\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of Class II heart failure\tand is asymptomatic on treatment may be considered eligible |
|
|
416 |
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 anti-coagulating agents for at least 6 weeks are eligible |
|
|
417 |
History of cerebrovascular accident including transient ischemic attack, untreated deep venous thrombosis (DVT) or pulmonary embolism within the past 6 months; patients with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible |
|
|
418 |
For Arm D only: History of seizure, unexplained loss of consciousness, transient ischemic attack within 12 months of enrollment, cerebral vascular accident, and any brain metastases |
|
|
419 |
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 anti-coagulating agents for at least 6 weeks are eligible but must be monitored regularly for changes in relevant coagulation parameters as clinically indicated as well as any clinical bleeding episodes |
|
|
420 |
Patients with a history of myocardial infarction, unstable angina, stroke, or transient ischemic attack (TIA) within 6 months prior to planned day 1 of dosing are ineligible |
|
|
421 |
Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis |
|
|
422 |
Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within the 6 months before start of FOLFIRI |
|
|
423 |
Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
424 |
Uncontrolled intercurrent illness including infection, congestive heart failure, myocardial infarction, transient ischemic attack or stroke within 6 months; any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary |
|
|
425 |
Patients with history of deep venous thrombus or pulmonary embolism; patients who are at increased risk of thrombosis during treatment with Revlimid including those taking concurrent erythropoietin, darbepoetin or high-dose corticosteroids are also excluded |
|
|
426 |
Patients with a history of embolic events (e.g. transient ischemic attack [TIA]) from arrhythmia or peripheral arterial disease or of recent myocardial infarction (MI) whether or not treated with anti-platelet drugs |
|
|
427 |
Patients must not have had a deep venous or arterial thrombosis (non-central venous catheter related) within the last three months prior to study entry |
|
|
428 |
Patients with cerebrovascular accident or transient ischemic attack within 6 months of therapy are excluded |
|
|
429 |
History of stroke or transient ischemic attack |
|
|
430 |
History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible |
|
|
431 |
EXPANSION COHORT ONLY: History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible |
|
|
432 |
Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months prior to enrollment. |
|
|
433 |
History of stroke or transient ischemic attack within six months |
|
|
434 |
Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study. |
|
|
435 |
Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months; hepatic portal vein thrombus is not considered an exclusion criterion |
|
|
436 |
No history of cerebrovascular accident or transient ischemic attacks |
|
|
437 |
Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, transient ischemic attack (TIA), or pulmonary embolism |
|
|
438 |
Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis |
|
|
439 |
Documented deep vein thrombosis within 1 year before enrollment on the study, except if upper arm thrombosis related to central venous catheters, within 3 months before enrollment on the study |
|
|
440 |
History of deep venous or arterial thrombotic disease (including but not limited to, acute myocardial infarction due to coronary thrombosis, ischemic stroke, and peripheral arterial disease), unless:\r\n* Line-related thrombosis without embolus\r\n* Occurring >= 1 year prior to screening |
|
|
441 |
History of a stroke or cerebrovascular accident (CVA) within 6 months |
|
|
442 |
Thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism. History of transient ischemic attack is allowed. |
|
|
443 |
Patients with a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation are eligible provided they are determined to be candidates for radical prostatectomy |
|
|
444 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months of study registration. |
|
|
445 |
Deep vein thrombosis in the preceding 2 months. |
|
|
446 |
History of stroke or transient ischemic attack (TIA) within 6 months prior to Cycle 1, Day 1 |
|
|
447 |
History of loss of consciousness or transient ischemic attack within 12 months of enrollment |
|
|
448 |
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication). |
|
|
449 |
Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of protocol therapy. |
|
|
450 |
Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event =< 30 days before enrollment |
|
|
451 |
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before start of study treatment. However, if a patient has recovered to ECOG performance status of ? 2 he/she may be enrolled provided that other eligibility criteria are met |
|
|
452 |
Any of the following within 6 months prior to study entry:\r\n* Myocardial infarction (MI)\r\n* Severe/unstable angina\r\n* Coronary artery bypass graft (CABG)\r\n* Congestive heart failure (CHF) > New York Heart Association (NYHA) II\r\n* Cerebrovascular accident (CVA)\r\n* Transient ischemic attack (TIA)\r\n* Pulmonary embolism (PE) |
|
|
453 |
Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug. |
|
|
454 |
History of cerebrovascular accident or transient ischemic attack. |
|
|
455 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment |
|
|
456 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment |
|
|
457 |
Cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 12 weeks prior to Baseline. |
|
|
458 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism that have initiated within 6 months of start of study treatment; stable, persistent events under appropriate management diagnosed > 6 months prior to treatment are allowed at the discretion of the investigator |
|
|
459 |
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism, or untreated deep venous thrombosis (DVT) within the past 6 months; subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible |
|
|
460 |
History of stroke or transient ischemic attack within 6 months prior to Day 1 |
|
|
461 |
Patients with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of study enrollment) |
|
|
462 |
No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study |
|
|
463 |
Have had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months prior to the initiation of study treatment. |
|
|
464 |
Any of the following within the 6 months prior to study drug administration: myocardial infarction, grade 2 or greater peripheral vascular disease, arterial thrombotic event, visceral arterial ischemia, cerebrovascular ischemia, transient ischemic attack, percutaneous transluminal angioplasty or stent, or unstable angina |
|
|
465 |
Pulmonary embolism, deep vein thrombosis, or other significant venous event =< 8 weeks before enrollment |
|
|
466 |
5. Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug. |
|
|
467 |
Known history of stroke or cerebrovascular accident within 6 months. |
|
|
468 |
Significant or active cardiovascular disease, specifically including but not restricted to:\r\n* History of myocardial infarction \r\n* History of atrial or ventricular arrhythmia\r\n* Unstable angina within 6 months prior to first dose of ponatinib\r\n* History of congestive heart failure \r\n* Left ventricular ejection fraction (LVEF) less than lower limit of normal \r\n* History of peripheral arterial occlusive disease \r\n* History of cerebrovascular accident or transient ischemic attack \r\n* Venous thromboembolism including deep venous thrombosis or pulmonary embolism within 6 months prior to enrollment |
|
|
469 |
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. |
|
|
470 |
History of cerebrovascular accident (CVA) within 6 months prior to registration or that is not stable. |
|
|
471 |
Thromboembolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
472 |
Participants with a recent history (< 6 months) of a major infarct including but not inclusive to bowel ischemia, cerebral vascular accident, transient ischemic attack, myocardial infarction, limb ischemia, or skin necrosis |
|
|
473 |
Has had within the past 6 months the occurrence of one or more of the following events: myocardial infarction, cerebrovascular accident, deep vein thrombosis, pulmonary embolism, hemorrhage (CTC Grade 3 or 4), chronic liver disease (meeting criteria for Child-Pugh Class B or C), a second active malignancy (excluding basal cell carcinoma and cervical carcinoma in situ), organ transplantation. |
|
|
474 |
Past history of stroke or transient ischemic attack requiring medical therapy |
|
|
475 |
Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
476 |
History of deep venous thromboses or pulmonary embolism =< 365 days prior to registration |
|
|
477 |
History of an ischemic insult in the previous 12 months (myocardial infarction, cerebral vascular accident, ischemic tissue from injury, transient ischemic attack. |
|
|
478 |
Participant has experienced any arterial thromboembolic event (ATE), including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, within 6 months prior to receiving study drugs. |
|
|
479 |
Have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolic event during the 3 months prior to receiving study drugs. |
|
|
480 |
The subject has the following cardiac conditions: unstable angina pectoris, clinically significant cardiac arrhythmias, history of stroke (including transient ischemic attack [TIA], or other ischemic event) within 6 months of study treatment, myocardial infarction within 6 months of study treatment, history of thromboembolic event requiring therapeutic anticoagulation within 6 months of study treatment or main portal vein or vena cava thrombosis or occlusion; (Note: subjects with a venous filter [e.g. vena cava filter] are not eligible for this study) |
|
|
481 |
Concomitant diseases/conditions: Unstable angina, myocardial infarction, valvular heart disease, encephalopathy, ischemic attacks, hemorrhagic or ischemic cerebrovascular accident (CVA) or ongoing pulmonary embolism within last year, arrhythmia, hepatopathy, uncontrolled infection, hemoptysis or oxygen requiring dyspnea, known HIV infection, bleeding risk, muscular problems, peripheral neuropathy, Symptomatic or progressive brain metastases or leptomeningeal disease. |
|
|
482 |
History of arterial or deep venous thromboembolism within the 12 months prior to enrollment |
|
|
483 |
No history of cerebrovascular accident or transient ischemic attacks within the past 6 months from registration |
|
|
484 |
Documented deep venous thrombosis |
|
|
485 |
History of cerebrovascular attack or transient ischemic attack within 6 months prior to the initiation of therapy on this protocol. |
|
|
486 |
Symptomatic peripheral vascular disease, stroke or transient ischemic attack within 6 months |
|
|
487 |
Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism. |
|
|
488 |
History of prior cerebrovascular accident (CVA), including transient ischemic attach (TIA) |
|
|
489 |
Occurrence of deep vein thrombosis within 4 weeks, prior to study entry |
|
|
490 |
Patients with either of the following within 6 months before the first dose of study treatment:\r\n* Stroke (including transient ischemic attack [TIA], or other ischemic event)\r\n* Myocardial infarction |
|
|
491 |
Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months of screening |
|
|
492 |
Any of the following within 3 months prior to study drug administration: myocardial infarction, unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism |
|
|
493 |
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication |
|
|
494 |
Deep vein thrombosis diagnosed within 3 months |
|
|
495 |
History within 3 months of deep vein thrombosis, pulmonary embolism, or stroke |
|
|
496 |
Diagnosed active deep vein thrombosis (DVT) that has not been therapeutically anticoagulated |
|
|
497 |
Cerebrovascular accident or pulmonary embolus within 3 months of randomization. |
|
|
498 |
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary emboli, cerebrovascular accident or ischemia will not be eligible |
|
|
499 |
Known history of cerebrovascular accident in the past 6 months. |
|
|
500 |
History of thromboembolic events and bleeding disorders ?3 months (e.g., (deep vein thrombosis) DVT or pulmonary embolism (PE)) |
|
|
501 |
Patients with a history of deep vein thrombosis or thromboembolism within < 6 months prior to starting study treatment |
|
|
502 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months of informed consent; Note: subjects with recent deep vein thrombosis (DVT) who have been treated with therapeutic anticoagulating agents for at least 6 weeks prior to study treatment are eligible |
|
|
503 |
Thrombolytic, embolic, venous, or arterial events such as cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
504 |
History of stroke or transient ischemic attack within 3 months prior to registration |
|
|
505 |
Known arterial or venous thrombosis or pulmonary embolism within 2 years |
|
|
506 |
Cerebrovascular accident or transient ischemic attack within 2 years |
|
|
507 |
History of stroke or transient ischemic attack within 6 months prior to beginning treatment. |
|
|
508 |
Prior or concurrent deep vein thrombosis or pulmonary embolism |
|
|
509 |
History of stroke or transient ischemic attack within 6 months prior to study enrollment |
|
|
510 |
History of cerebrovascular accident including transient ischemic attack, pulmonary embolism, or untreated deep venous thrombosis within the past 6 months. |
|
|
511 |
Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
512 |
No history of cerebrovascular accident or transient ischemic attacks within the past 6 months |
|
|
513 |
History (within the last 6 months) or presence of stroke/cerebrovascular accident |
|
|
514 |
Has experienced any arterial thrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident within 6 months prior to randomization |
|
|
515 |
Thrombosis or vascular ischemic events within the last twelve months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction |
|
|
516 |
Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
517 |
History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months; subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible |
|
|
518 |
No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of registration for protocol therapy. |
|
|
519 |
History of deep vein thrombosis or pulmonary embolism. |
|
|
520 |
Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
521 |
DONOR: No other medical contraindications to stem cell donation (i.e. severe atherosclerosis, autoimmune disease, iritis or episcleritis, deep venous thrombosis, cerebrovascular accident); patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis |
|
|
522 |
Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months |
|
|
523 |
Patients with a history of deep vein thrombosis or thromboembolism within < 6 months prior to starting study treatment |
|
|
524 |
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 anti-coagulating agents for at least 6 weeks are eligible |
|
|
525 |
History of cerebrovascular accident within the past 6 months (e.g. transient ischemic attack [TIA]) |
|
|
526 |
Have had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 3 months prior to the initiation of study treatment |
|
|
527 |
History of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) =< 180 days |
|
|
528 |
History of stroke or transient ischemic attack within 6 months prior to day 1 |
|
|
529 |
Patients must not have a prior history of deep vein thrombosis (DVT) or pulmonary embolism in the past 5 years |
|
|
530 |
Patients who have had a deep vein thrombosis or pulmonary embolus within the past 6 months are eligible if they are on stable therapeutic anticoagulation |
|
|
531 |
History of dementia, Alzheimer’s disease, multi-infarct dementia or cerebrovascular accident (CVA) (history of transient ischemic attack [TIA] is allowed) |
|
|
532 |
Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or severe uncontrolled ventricular arrhythmia. |
|
|
533 |
Cerebrovascular accident (CVA), transient ischemic attack (TIA) within the last 6 months prior to registration |
|
|
534 |
History of stroke or transient ischemic attack within 3 months of first study dose |
|
|
535 |
Active deep vein thrombosis in the treatment extremity |
|
|
536 |
Cerebrovascular accident (CVA) or stroke within the past 6 months |
|
|
537 |
History of arterial or venous thrombosis (excluding line-thrombosis) within the last 1 year, or those with known inherited coagulopathies; arterial or venous thrombosis includes pulmonary embolism, deep vein thrombosis of both upper (excluding line-thrombosis) and lower extremities, coronary artery disease managed medically or requiring intervention (percutaneous stent placement or coronary bypass surgery), cerebrovascular accident (for transient ischemic attacks clinical documentation is required), or involvement of other organs (such as hepatic, renal, spleen or other sites) |
|
|
538 |
Arterial or venous thrombosis in the last year except for line-related venous thrombosis more than 3 months ago |
|
|
539 |
Subjects with history of evidence upon physical examination of central nervous system (CNS) disease including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within six months of study entry |
|
|
540 |
History of deep vein thrombosis (DVT) in the lymphedematous upper extremity |
|
|
541 |
No history of stroke or transient ischemic attack |
|
|
542 |
History of a deep venous thrombosis or a thromboembolism |
|
|
543 |
Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment within 6 months of informed consent |
|
|
544 |
History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to Day 1 |
|
|
545 |
Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, <6 months prior to randomization. |
|
|
546 |
Patients with a history of a prior symptomatic venous thrombotic event, such as deep venous thrombosis (DVT) or pulmonary embolism and symptomatic arterial thrombotic events such as myocardial infarction, ischemic cerebral vascular accident or transient ischemic attack will be ineligible if they have not tolerated anticoagulation therapy; if patients remain on anticoagulation, or have completed the prescribed course of anticoagulation, they will be eligible for enrollment; a venous thrombotic event associated with a central venous catheter will not make the patient ineligible |
|
|
547 |
Patients with existing deep venous thrombosis will be excluded |
|
|
548 |
Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE), in six months prior to enrollment are not eligible for this study |
|
|
549 |
History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization. |
|
|
550 |
History of thrombosis, deep vein thrombosis, pulmonary emboli, or embolic stroke AND have not been stable on anticoagulants within the past 6 months; local central line thrombosis is allowed |
|
|
551 |
Within the past 6 months:\r\n* Acute pulmonary embolus\r\n* Deep vein thrombosis |
|
|
552 |
CONTROL (HEALTHY) GROUP: Within the past 6 months:\r\n* Acute pulmonary embolus\r\n* Deep vein thrombosis |
|
|
553 |
Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization, arrhythmia requiring treatment such as atrial fibrillation, congestive heart failure, peripheral vascular disease, pulmonary embolism, or deep venous thrombosis. |
|
|
554 |
Arterial or venous thrombosis requiring active anticoagulation; (if a patient has a history of arterial or venous thrombosis and has completed anticoagulation therapy, then he/she is not excluded) |
|
|
555 |
Known history of VTE prior to diagnosis (deep vein thrombosis [DVT] or pulmonary embolism PE) due to increased underlying risk of new event |
|
|
556 |
History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA) |
|
|
557 |
History of blood clots (i.e. pulmonary embolism, deep vein thrombosis [DVTs]) |
|
|
558 |
Atherosclerotic cardiovascular disease (ASCVD) defined by history of acute coronary syndromes, myocardial infarction (MI), stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin |
|
|
559 |
Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure |
|
|
560 |
History of cerebrovascular accident or transient ischemic attack within 3 months of first study dose |
|
|
561 |
History of deep vein thrombosis or pulmonary embolism within 4 weeks of first study dose |
|
|
562 |
Has an unstable neurological disease (e.g. cerebrovascular accident [including transient ischemic attacks (TIAs)]) within the 3 months before signing of informed consent |
|
|
563 |
Patient must not have history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months\r\n* Note: subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible |
|
|
564 |
History of cerebrovascular accident (stroke) |
|
|
565 |
History of progressive promyelocytic leukemia (PML), known history of pancreatitis, active grade 3 or higher viral, bacterial or fungal infection =< 2 weeks prior to registration and documented history of cerebrovascular event (stroke or transient ischemic attack [TIA]) =< 6 months prior to registration |
|
|
566 |
Symptomatic deep vein thrombosis or pulmonary embolism within last 6 months |
|
|
567 |
Stroke or transient ischemic attack within 6 months of screening |
|
|
568 |
Uncontrolled active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months |
|
|
569 |
Subjects with a history of evidence upon physical examination of central nervous system (CNS) disease including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within six months of study entry |
|
|
570 |
Patients who have a history of venous or arterial thromboembolic events including pulmonary embolism, deep venous thrombosis and stroke |
|
|
571 |
History of stroke or transient ischemic attack in the preceding 6 months |
|
|
572 |
History of stroke/transient ischemic attack |
|
|
573 |
No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of starting IFN gamma |
|
|
574 |
History of loss of consciousness or transient ischemic attack within past 12 months |
|
|
575 |
Any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack. |
|
|
576 |
History of deep vein thrombosis or pulmonary embolism. |
|
|
577 |
Subjects with stroke, arterial or venous thrombosis within 6 months not eligible |
|
|
578 |
Cerebrovascular accident or transient ischemia. |
|
|
579 |
Active deep venous thrombosis, pulmonary embolism, retinal vascular thrombosis, and any arterial thrombosis including stroke and myocardial infarction or history of these conditions |
|
|
580 |
Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the past 6 months. Deep venous thrombosis within 6 months, unless the patient is therapeutically anti-coagulated for at least 2 weeks. In this situation, low molecular weight heparin is preferred |