{
    "info": {
        "nct_id": "NCT00888173",
        "official_title": "A Phase II Evaluation of Brivanib (BMS582664), an Oral, Multitargeted Growth Factor Tyrosine Kinase Inhibitor in the Treatment of Recurrent or Persistent Endometrial Carcinoma",
        "inclusion_criteria": "* Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required\n\n  * Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell, and transitional cell carcinoma\n* All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT\n* Patients must have at least one ?target lesion? to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST); tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy\n* Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III or Rare Tumor protocol for the same patient population\n* Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1\n* Recovery from effects of recent surgery, radiotherapy, or chemotherapy\n* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration\n* Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration\n* Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer will be counted as a systemic chemotherapy regimen\n* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent endometrial disease according to the following definition:\n\n  * Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa\n  * Note: Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent endometrial disease, as defined above; however, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy\n* Patients must NOT have received any non-cytotoxic therapy for management of endometrial cancer with the exception of hormonal therapy\n* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1\n* Platelets greater than or equal to 100,000/mcl\n* Hemoglobin > 9 g/dl\n* Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1\n* Urinalysis needs to be assessed at baseline and proteinuria must be less than or equal to 3+ by dipstick (CTCAE v3.0 grade 2 or less); if the urine dipstick is > 3+, a 24-hour protein level can be done, as clinically indicated by the investigator; the 24-hour protein level must be less than or equal to 3.5 g/24 hours (CTCAE v3.0 grade 2 or less)\n* Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)\n* Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)\n* Albumin greater than or equal to 2.5 g/dl\n* Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1\n* Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 x ULN; patients on therapeutic warfarin are excluded from trial, anticoagulation with low molecular weight heparin is allowed\n* Patients must have signed an approved informed consent and authorization permitting release of personal health information\n* Patients must meet pre-entry requirements\n* Patients of childbearing potential must have a negative serum pregnancy test performed 48 hours prior to study entry and be practicing an effective form of contraception during the study and for at least 3 months after receiving the final treatment of brivanib\n* All patients must have a baseline electrocardiogram completed prior to study entry; baseline electrocardiogram (ECG) should be repeated if corrected QT interval (QTc) is found to be > 450 msec; QTc must NOT be > 450 msec on both ECGs performed during the same visit\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who have had prior therapy with brivanib or anti-vascular, anti-PDGFR (platelet-derived growth factor receptor) or anti-FGFR (fibroblast growth factor receptor) therapy\n* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted below, are excluded if there is any evidence of the other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy\n* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease\n* Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease\n* Patients that are on required chronic anti-platelet therapy (aspirin > 300 mg/day, or clopidogrel greater than or equal to 75 mg/day)\n* Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE grade >= 3 within 30 days prior to study entry\n* Patients with a history of poor wound healing, non healing ulcers or bone fractures within the last 3 months\n* Patients with uncontrolled or significant cardiovascular disease including:\n\n  * Myocardial infarction within 12 months\n  * Uncontrolled angina within 12 months\n  * Class III-IV New York Heart Association (NYHA) congestive heart failure\n  * Uncontrolled hypertension (systolic blood pressure [BP] > 150 or diastolic BP > 100 mmHg for 24 hours) despite optimized anti-hypertensive therapy; BP must be below 150/100 mmHg at screening; subjects with a history of hypertension who are receiving treatment with calcium channel blockers that are cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors should be changed to an alternative antihypertensive medication before study entry\n  * History of stroke, transient ischemic attack (TIA), or other central nervous system (CNS) ischemic event\n  * Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin\n  * Patients must have pre-therapy left ventricle ejection fraction (LVEF) testing and have an ejection fraction > 50%\n  * Patients with valvular heart disease >= CTCAE grade2\n* Patients with a serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy\n* Pre-existing thyroid abnormality with thyroid function that can not be maintained in the normal range with medication\n* Patients with hyponatremia (sodium < 130 mEq/L)\n* Patients with active/known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C\n* Patients with known brain metastases\n* Patients who are pregnant or nursing\n* Patients with inability to swallow tablets or untreated malabsorption syndrome\n* Baseline serum potassium < 3.5 mmol/L (potassium supplementation may be given to restore the serum potassium above this level prior to entry study)\n* Patients on therapeutic warfarin anticoagulation will be excluded; patients converted to anticoagulation with a heparin compound will be allowed provided the patient?s PT is such that international normalized ratio (INR) is =< 1.5 x ULN",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required",
            "criterions": [
                {
                    "exact_snippets": "recurrent or persistent endometrial carcinoma",
                    "criterion": "endometrial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "recurrent",
                                "persistent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to curative therapy or established treatments",
                    "criterion": "endometrial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment response",
                            "expected_value": "refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic confirmation of the original primary tumor is required",
                    "criterion": "histologic confirmation of the original primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell, and transitional cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "histologic epithelial cell types ... endometrioid adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "endometrioid adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... serous adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "serous adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... undifferentiated carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "undifferentiated carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... clear cell adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "clear cell adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... mixed epithelial carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "mixed epithelial carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... adenocarcinoma not otherwise specified (N.O.S.)",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "adenocarcinoma not otherwise specified (N.O.S.)"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... mucinous adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "mucinous adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... squamous cell",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "squamous cell"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... transitional cell carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "transitional cell carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT",
            "criterions": [
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one lesion that can be accurately measured in at least one dimension",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "each lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI)",
                    "criterion": "lesion size (conventional techniques)",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "each lesion must be ... >= 10 mm when measured by spiral CT",
                    "criterion": "lesion size (spiral CT)",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have at least one ?target lesion? to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST); tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients must have at least one ?target lesion?",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented",
                    "criterion": "tumors within a previously irradiated field",
                    "requirements": [
                        {
                            "requirement_type": "designation",
                            "expected_value": "non-target lesions"
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors within a previously irradiated field will be designated as ?non-target? lesions unless ... a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
                    "criterion": "biopsy to confirm persistence",
                    "requirements": [
                        {
                            "requirement_type": "time since radiation therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III or Rare Tumor protocol for the same patient population",
            "criterions": [
                {
                    "exact_snippets": "Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol",
                    "criterion": "eligibility for higher priority GOG protocol",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any active GOG Phase III or Rare Tumor protocol for the same patient population",
                    "criterion": "active GOG Phase III or Rare Tumor protocol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2",
                    "criterion": "GOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have received two prior regimens must have a GOG performance status of 0 or 1",
                    "criterion": "GOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovery from effects of recent surgery, radiotherapy, or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Recovery from effects of recent surgery",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                },
                {
                    "exact_snippets": "Recovery from effects of recent ... radiotherapy",
                    "criterion": "recovery from radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                },
                {
                    "exact_snippets": "Recovery from effects of recent ... chemotherapy",
                    "criterion": "recovery from chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])",
            "criterions": [
                {
                    "exact_snippets": "free of active infection requiring antibiotics",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of uncomplicated urinary tract infection [UTI]",
                    "criterion": "uncomplicated urinary tract infection (UTI)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time before registration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration",
                    "criterion": "prior therapy directed at the malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer will be counted as a systemic chemotherapy regimen",
            "criterions": [
                {
                    "exact_snippets": "Patients must have had one prior chemotherapeutic regimen",
                    "criterion": "prior chemotherapeutic regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "management of endometrial carcinoma",
                    "criterion": "endometrial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "management",
                            "expected_value": "chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy administered in conjunction with primary radiation as a radio-sensitizer",
                    "criterion": "chemotherapy with radiation",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": "in conjunction with primary radiation as a radio-sensitizer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent endometrial disease according to the following definition:",
            "criterions": [
                {
                    "exact_snippets": "Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen",
                    "criterion": "cytotoxic regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "additional"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "management of recurrent or persistent endometrial disease",
                    "criterion": "endometrial disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "recurrent",
                                "persistent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa",
            "criterions": [
                {
                    "exact_snippets": "Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells",
                    "criterion": "cytotoxic regimen",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": [
                                "genetic apparatus",
                                "mitotic apparatus"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "resulting in dose-limiting toxicity to the bone marrow",
                    "criterion": "dose-limiting toxicity",
                    "requirements": [
                        {
                            "requirement_type": "affected area",
                            "expected_value": "bone marrow"
                        }
                    ]
                },
                {
                    "exact_snippets": "resulting in dose-limiting toxicity to the ... gastrointestinal mucosa",
                    "criterion": "dose-limiting toxicity",
                    "requirements": [
                        {
                            "requirement_type": "affected area",
                            "expected_value": "gastrointestinal mucosa"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Note: Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent endometrial disease, as defined above; however, patients are encouraged to enroll on second-line non-cytotoxic studies prior to receiving additional cytotoxic therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen",
                    "criterion": "cytotoxic chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "additional"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "management of recurrent or persistent endometrial disease",
                    "criterion": "endometrial disease",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": [
                                "recurrent",
                                "persistent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must NOT have received any non-cytotoxic therapy for management of endometrial cancer with the exception of hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "Patients must NOT have received any non-cytotoxic therapy for management of endometrial cancer",
                    "criterion": "non-cytotoxic therapy for endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mcl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets greater than or equal to 100,000/mcl",
            "criterions": [
                {
                    "exact_snippets": "Platelets greater than or equal to 100,000/mcl",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin > 9 g/dl",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 9 g/dl",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1",
            "criterions": [
                {
                    "exact_snippets": "Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit normal (ULN)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CTCAE v3.0 grade 1",
                    "criterion": "CTCAE grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urinalysis needs to be assessed at baseline and proteinuria must be less than or equal to 3+ by dipstick (CTCAE v3.0 grade 2 or less); if the urine dipstick is > 3+, a 24-hour protein level can be done, as clinically indicated by the investigator; the 24-hour protein level must be less than or equal to 3.5 g/24 hours (CTCAE v3.0 grade 2 or less)",
            "criterions": [
                {
                    "exact_snippets": "Urinalysis needs to be assessed at baseline",
                    "criterion": "urinalysis",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "baseline"
                        }
                    ]
                },
                {
                    "exact_snippets": "proteinuria must be less than or equal to 3+ by dipstick",
                    "criterion": "proteinuria by dipstick",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "24-hour protein level must be less than or equal to 3.5 g/24 hours",
                    "criterion": "24-hour protein level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.5,
                                "unit": "g/24 hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than or equal to 1.5 x ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... less than or equal to 2.5 x ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ... less than or equal to 2.5 x ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase less than or equal to 2.5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin greater than or equal to 2.5 g/dl",
            "criterions": [
                {
                    "exact_snippets": "Albumin greater than or equal to 2.5 g/dl",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1",
            "criterions": [
                {
                    "exact_snippets": "Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1",
                    "criterion": "neuropathy (sensory and motor)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE v3.0 grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 x ULN; patients on therapeutic warfarin are excluded from trial, anticoagulation with low molecular weight heparin is allowed",
            "criterions": [
                {
                    "exact_snippets": "Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 x ULN",
                    "criterion": "international normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients on therapeutic warfarin are excluded from trial",
                    "criterion": "therapeutic warfarin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anticoagulation with low molecular weight heparin is allowed",
                    "criterion": "anticoagulation with low molecular weight heparin",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have signed an approved informed consent and authorization permitting release of personal health information",
            "criterions": [
                {
                    "exact_snippets": "signed an approved informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "authorization permitting release of personal health information",
                    "criterion": "authorization for release of personal health information",
                    "requirements": [
                        {
                            "requirement_type": "authorization",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must meet pre-entry requirements",
            "criterions": [
                {
                    "exact_snippets": "pre-entry requirements",
                    "criterion": "pre-entry requirements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients of childbearing potential must have a negative serum pregnancy test performed 48 hours prior to study entry and be practicing an effective form of contraception during the study and for at least 3 months after receiving the final treatment of brivanib",
            "criterions": [
                {
                    "exact_snippets": "Patients of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test performed 48 hours prior to study entry",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "48 hours prior to study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "practicing an effective form of contraception during the study and for at least 3 months after receiving the final treatment of brivanib",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for at least 3 months after receiving the final treatment of brivanib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients must have a baseline electrocardiogram completed prior to study entry; baseline electrocardiogram (ECG) should be repeated if corrected QT interval (QTc) is found to be > 450 msec; QTc must NOT be > 450 msec on both ECGs performed during the same visit",
            "criterions": [
                {
                    "exact_snippets": "baseline electrocardiogram completed",
                    "criterion": "baseline electrocardiogram",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "corrected QT interval (QTc) ... > 450 msec",
                    "criterion": "corrected QT interval (QTc)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc must NOT be > 450 msec on both ECGs",
                    "criterion": "QTc on both ECGs",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 450,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who have had prior therapy with brivanib or anti-vascular, anti-PDGFR (platelet-derived growth factor receptor) or anti-FGFR (fibroblast growth factor receptor) therapy",
            "criterions": [
                {
                    "exact_snippets": "prior therapy with brivanib",
                    "criterion": "prior brivanib therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior therapy with ... anti-vascular",
                    "criterion": "prior anti-vascular therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior therapy with ... anti-PDGFR (platelet-derived growth factor receptor)",
                    "criterion": "prior anti-PDGFR therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior therapy with ... anti-FGFR (fibroblast growth factor receptor)",
                    "criterion": "prior anti-FGFR therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted below, are excluded if there is any evidence of the other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy",
            "criterions": [
                {
                    "exact_snippets": "history of other invasive malignancies",
                    "criterion": "history of other invasive malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of the other malignancy being present within the last three years",
                    "criterion": "presence of other malignancy within the last three years",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous cancer treatment contraindicates this protocol therapy",
                    "criterion": "previous cancer treatment contraindication",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded",
                    "criterion": "prior radiotherapy to abdominal cavity or pelvis",
                    "requirements": [
                        {
                            "requirement_type": "treatment exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration",
                    "criterion": "prior radiation for localized cancer of the breast, head and neck, or skin",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "the patient remains free of recurrent or metastatic disease",
                    "criterion": "recurrent or metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years",
                    "criterion": "prior chemotherapy for abdominal or pelvic tumor",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration",
                    "criterion": "prior adjuvant chemotherapy for localized breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patient remains free of recurrent or metastatic disease",
                    "criterion": "recurrent or metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients that are on required chronic anti-platelet therapy (aspirin > 300 mg/day, or clopidogrel greater than or equal to 75 mg/day)",
            "criterions": [
                {
                    "exact_snippets": "Patients that are on required chronic anti-platelet therapy",
                    "criterion": "chronic anti-platelet therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "aspirin > 300 mg/day",
                    "criterion": "aspirin dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 300,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clopidogrel greater than or equal to 75 mg/day",
                    "criterion": "clopidogrel dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE grade >= 3 within 30 days prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other hemorrhage/bleeding event CTCAE grade >= 3 within 30 days prior to study entry",
                    "criterion": "hemorrhage/bleeding event",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "CTCAE grade"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 30 days prior to study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of poor wound healing, non healing ulcers or bone fractures within the last 3 months",
            "criterions": [
                {
                    "exact_snippets": "history of poor wound healing",
                    "criterion": "poor wound healing",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non healing ulcers",
                    "criterion": "non healing ulcers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bone fractures within the last 3 months",
                    "criterion": "bone fractures",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with uncontrolled or significant cardiovascular disease including:",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled or significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction within 12 months",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction within 12 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled angina within 12 months",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled angina within 12 months",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 12 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Class III-IV New York Heart Association (NYHA) congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "Class III-IV New York Heart Association (NYHA) congestive heart failure",
                    "criterion": "New York Heart Association (NYHA) congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension (systolic blood pressure [BP] > 150 or diastolic BP > 100 mmHg for 24 hours) despite optimized anti-hypertensive therapy; BP must be below 150/100 mmHg at screening; subjects with a history of hypertension who are receiving treatment with calcium channel blockers that are cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors should be changed to an alternative antihypertensive medication before study entry",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure [BP] > 150",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic BP > 100 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "BP must be below 150/100 mmHg at screening",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 150,
                                "unit": "systolic mmHg"
                            }
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "diastolic mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects with a history of hypertension",
                    "criterion": "history of hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with calcium channel blockers that are cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors",
                    "criterion": "calcium channel blockers (CYP3A4 inhibitors)",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "should be changed to an alternative antihypertensive medication before study entry",
                    "criterion": "antihypertensive medication change",
                    "requirements": [
                        {
                            "requirement_type": "action",
                            "expected_value": "change to alternative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of stroke, transient ischemic attack (TIA), or other central nervous system (CNS) ischemic event",
            "criterions": [
                {
                    "exact_snippets": "History of stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack (TIA)",
                    "criterion": "transient ischemic attack (TIA)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other central nervous system (CNS) ischemic event",
                    "criterion": "central nervous system (CNS) ischemic event",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin",
            "criterions": [
                {
                    "exact_snippets": "Cardiac arrhythmias requiring anti-arrhythmic therapy",
                    "criterion": "cardiac arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "anti-arrhythmic therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "other than beta blockers or digoxin",
                    "criterion": "anti-arrhythmic therapy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "beta blockers",
                                "digoxin"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have pre-therapy left ventricle ejection fraction (LVEF) testing and have an ejection fraction > 50%",
            "criterions": [
                {
                    "exact_snippets": "pre-therapy left ventricle ejection fraction (LVEF) testing",
                    "criterion": "left ventricle ejection fraction (LVEF) testing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ejection fraction > 50%",
                    "criterion": "ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with valvular heart disease >= CTCAE grade2",
            "criterions": [
                {
                    "exact_snippets": "valvular heart disease >= CTCAE grade2",
                    "criterion": "valvular heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy",
            "criterions": [
                {
                    "exact_snippets": "serious uncontrolled medical disorder",
                    "criterion": "medical disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing thyroid abnormality with thyroid function that can not be maintained in the normal range with medication",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing thyroid abnormality",
                    "criterion": "thyroid abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "thyroid function that can not be maintained in the normal range with medication",
                    "criterion": "thyroid function",
                    "requirements": [
                        {
                            "requirement_type": "maintenance with medication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with hyponatremia (sodium < 130 mEq/L)",
            "criterions": [
                {
                    "exact_snippets": "hyponatremia",
                    "criterion": "hyponatremia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sodium < 130 mEq/L",
                    "criterion": "sodium level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 130,
                                "unit": "mEq/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with active/known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C",
            "criterions": [
                {
                    "exact_snippets": "active/known human immunodeficiency virus (HIV)",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active/known ... hepatitis B",
                    "criterion": "hepatitis B status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active/known ... hepatitis C",
                    "criterion": "hepatitis C status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with known brain metastases",
            "criterions": [
                {
                    "exact_snippets": "known brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Patients who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with inability to swallow tablets or untreated malabsorption syndrome",
            "criterions": [
                {
                    "exact_snippets": "inability to swallow tablets",
                    "criterion": "ability to swallow tablets",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Baseline serum potassium < 3.5 mmol/L (potassium supplementation may be given to restore the serum potassium above this level prior to entry study)",
            "criterions": [
                {
                    "exact_snippets": "Baseline serum potassium < 3.5 mmol/L",
                    "criterion": "serum potassium",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.5,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients on therapeutic warfarin anticoagulation will be excluded; patients converted to anticoagulation with a heparin compound will be allowed provided the patient?s PT is such that international normalized ratio (INR) is =< 1.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Patients on therapeutic warfarin anticoagulation will be excluded",
                    "criterion": "therapeutic warfarin anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients converted to anticoagulation with a heparin compound will be allowed",
                    "criterion": "anticoagulation with a heparin compound",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provided the patient?s PT is such that international normalized ratio (INR) is =< 1.5 x ULN",
                    "criterion": "international normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}