{
    "info": {
        "nct_id": "NCT01642082",
        "official_title": "A Phase II Evaluation of Dalantercept, a Novel Soluble Recombinant Activin Receptor-Like Kinase 1 (ALK-1) Inhibitor Receptor-Fusion Protein, in the Treatment of Recurrent or Persistent Endometrial Carcinoma",
        "inclusion_criteria": "* Patients must have recurrent or persistent endometrial carcinoma; 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 carcinoma, and transitional cell carcinoma\n* All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or MRI\n* Patients must have at least one \"target lesion\" to be used to assess response on this protocol as defined by RECIST version 1.1; 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 protocol 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\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 chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration; any investigational drug must be discontinued at least 30 days prior to registration\n  * Any prior radiation therapy must be discontinued at least four weeks prior to registration\n  * At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay in treatment for minor procedures (e.g., central venous access catheter placement)\n* Prior therapy\n\n  * Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; 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 disease\n  * Patients must have NOT received any non-cytotoxic (biologic or targeted) agent(s) for management of recurrent or persistent disease; prior non-cytotoxic (biologic or targeted) agent(s) is allowed as part of initial treatment; prior hormonal therapy is allowed, but must be discontinued at least one week prior to registration\n* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL\n* Platelets greater than or equal to 100,000/mcL\n* Hemoglobin greater than or equal to 9 g/dL\n* Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN)\n* Sodium greater than or equal to 130 mEq/L (Common Terminology Criteria for Adverse Events [CTCAE] v. 4, grade 0 or 1)\n* Urine protein should be screened by urinalysis; if protein is 2+ or higher, 24-hour urine protein should be obtained and the level should be < 1,000 mg (< 1.0 g/24 hrs) for patient enrollment\n* Bilirubin less than or equal to 1.5 times ULN\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 times ULN\n* Alkaline phosphatase less than or equal to 3 times ULN\n* Albumin greater than or equal to 3 (CTCAE v. 4, grade 0 or 1)\n* Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 times ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin)\n* Partial thromboplastin time (PTT) less than or equal to 1.5 times ULN\n* Left ventricular ejection fraction (LVEF) greater than 50% (measured by echocardiogram or MUGA [multi-gated acquisition] scan)\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 prior to the study entry and be practicing an effective form of contraception\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who have had prior therapy with dalantercept or other inhibitor of the ALK1 pathway\n* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of 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 with history or evidence upon physical exam of central nervous system disease (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases or leptomeningeal disease\n* Serious or non-healing wound, ulcer, or bone fracture\n* History of abdominal fistula or anastomotic leak, gastrointestinal perforation, or intra-abdominal abscess within 6 months of registration\n* Patients requiring parenteral hydration or parenteral/total parenteral nutrition\n* No patients with:\n\n  * Active bleeding (e.g., active hemoptysis, defined as bright red blood of greater than or equal to ½ teaspoon [2.5 ml] in any 24-hour period) within 2 weeks prior to registration or gastrointestinal bleeding within 3 months prior to registration\n  * Hereditary hemorrhagic telangiectasia (HHT)\n  * Platelet function abnormality\n  * Autoimmune or hereditary hemolysis\n  * Coagulopathy, or\n  * Tumor involving major vessels (defined as any lesion invading or abutting the wall [i.e., no fat plane evident] of major blood vessels as assessed by CT or MRI)\n* Patients receiving treatment with full-dose aspirin (325 mg oral daily), clopidogrel (Plavix), or dabigatran (Pradaxa)\n* Patients with peripheral edema greater than or equal to grade 1 within 4 weeks of registration\n* No patients with clinically significant cardiovascular disease:\n\n  * Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications\n  * Evidence of hypertrophic cardiomyopathy\n  * New York Heart Association (NYHA) class II or greater congestive heart failure (CHF)\n  * Any of the following within 6 months prior to study registration:\n\n    * Bypass surgery\n    * Stent placement\n    * Myocardial infarction\n    * Acute coronary syndrome/unstable angina\n    * Hospitalization for congestive heart failure (CHF)\n  * Serious cardiac arrhythmia requiring medication; this does not include asymptomatic atrial fibrillation with controlled ventricular rate\n  * Prolonged QTc interval > 450 ms\n  * Prior anthracycline cumulative dose > 450 mg/m^2\n* Patients who are pregnant or nursing\n* History of syndrome of inappropriate antidiuretic hormone secretion (SIADH)\n* Patients who have undergone a therapeutic paracentesis within 4 weeks of registration\n* Known history of positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), or HBV core antibody, or human immunodeficiency virus (HIV) antibody results\n* History of severe (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v.4.0 >= grade 3) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients (10 mM Tris buffered saline) in the investigational agent\n* Clinically significant active pulmonary risk including pulmonary hypertension, pulmonary embolism, or history of pulmonary edema",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have recurrent or persistent endometrial carcinoma; 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": "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 carcinoma, and transitional cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "histologic epithelial cell types ... Endometrioid adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "Endometrioid adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... serous adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "serous adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... undifferentiated carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "undifferentiated carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... clear cell adenocarcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "clear cell adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... mixed epithelial carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "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": "type",
                            "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": "type",
                            "expected_value": "mucinous adenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... squamous cell carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "squamous cell carcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic epithelial cell types ... transitional cell carcinoma",
                    "criterion": "histologic epithelial cell type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "transitional cell carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or MRI",
            "criterions": [
                {
                    "exact_snippets": "measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam",
                    "criterion": "lesion size (CT, MRI, caliper)",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be ... >= 20 mm when measured by chest x-ray",
                    "criterion": "lesion size (chest x-ray)",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph nodes must be > 15 mm in short axis when measured by CT or MRI",
                    "criterion": "lymph node size (CT, MRI)",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have at least one \"target lesion\" to be used to assess response on this protocol as defined by RECIST version 1.1; 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",
                    "requirements": [
                        {
                            "requirement_type": "confirmation of persistence",
                            "expected_value": true
                        },
                        {
                            "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 protocol 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": "active GOG phase III protocol",
                    "criterion": "active GOG phase III protocol",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "rare tumor protocol for the same patient population",
                    "criterion": "rare tumor protocol for the same patient population",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "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",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one week prior to registration",
                    "criterion": "discontinuation period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration; any investigational drug must be discontinued at least 30 days prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Any other prior therapy directed at the malignant tumor, including chemotherapy and 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"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any investigational drug must be discontinued at least 30 days prior to registration",
                    "criterion": "investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any prior radiation therapy must be discontinued at least four weeks prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Any prior radiation therapy must be discontinued",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least four weeks prior to registration",
                    "criterion": "time since discontinuation of prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy); there is no delay in treatment for minor procedures (e.g., central venous access catheter placement)",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks must have elapsed since the patient underwent any major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "there is no delay in treatment for minor procedures",
                    "criterion": "delay in treatment for minor procedures",
                    "requirements": [
                        {
                            "requirement_type": "delay",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; 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": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease",
            "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 disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "recurrent",
                                "persistent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have NOT received any non-cytotoxic (biologic or targeted) agent(s) for management of recurrent or persistent disease; prior non-cytotoxic (biologic or targeted) agent(s) is allowed as part of initial treatment; prior hormonal therapy is allowed, but must be discontinued at least one week prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Patients must have NOT received any non-cytotoxic (biologic or targeted) agent(s) for management of recurrent or persistent disease",
                    "criterion": "non-cytotoxic agent for recurrent or persistent disease",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prior non-cytotoxic (biologic or targeted) agent(s) is allowed as part of initial treatment",
                    "criterion": "non-cytotoxic agent as part of initial treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior hormonal therapy is allowed, but must be discontinued at least one week prior to registration",
                    "criterion": "prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL",
            "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": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin greater than or equal to 9 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin greater than or equal to 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Creatinine less than or equal to 1.5 times institutional upper limit normal (ULN)",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times institutional upper limit normal (ULN)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sodium greater than or equal to 130 mEq/L (Common Terminology Criteria for Adverse Events [CTCAE] v. 4, grade 0 or 1)",
            "criterions": [
                {
                    "exact_snippets": "Sodium greater than or equal to 130 mEq/L",
                    "criterion": "sodium level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 130,
                                "unit": "mEq/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urine protein should be screened by urinalysis; if protein is 2+ or higher, 24-hour urine protein should be obtained and the level should be < 1,000 mg (< 1.0 g/24 hrs) for patient enrollment",
            "criterions": [
                {
                    "exact_snippets": "Urine protein should be screened by urinalysis",
                    "criterion": "urine protein",
                    "requirements": [
                        {
                            "requirement_type": "screening",
                            "expected_value": "urinalysis"
                        }
                    ]
                },
                {
                    "exact_snippets": "if protein is 2+ or higher",
                    "criterion": "urine protein",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "24-hour urine protein should be obtained",
                    "criterion": "24-hour urine protein",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the level should be < 1,000 mg (< 1.0 g/24 hrs)",
                    "criterion": "24-hour urine protein",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "mg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than or equal to 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than or equal to 1.5 times ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... less than or equal to 3 times ULN",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) less than or equal to 3 times ULN",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase less than or equal to 3 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase less than or equal to 3 times ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin greater than or equal to 3 (CTCAE v. 4, grade 0 or 1)",
            "criterions": [
                {
                    "exact_snippets": "Albumin greater than or equal to 3",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CTCAE v. 4, grade 0 or 1",
                    "criterion": "CTCAE grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 times ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin)",
            "criterions": [
                {
                    "exact_snippets": "Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 times ULN",
                    "criterion": "international normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin",
                    "criterion": "international normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": ""
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": ""
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Partial thromboplastin time (PTT) less than or equal to 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Partial thromboplastin time (PTT) less than or equal to 1.5 times ULN",
                    "criterion": "partial thromboplastin time (PTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Left ventricular ejection fraction (LVEF) greater than 50% (measured by echocardiogram or MUGA [multi-gated acquisition] scan)",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction (LVEF) greater than 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured by echocardiogram or MUGA [multi-gated acquisition] scan",
                    "criterion": "measurement method for LVEF",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "echocardiogram",
                                "MUGA [multi-gated acquisition] scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "N/A",
                            "expected_value": "met"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception",
            "criterions": [
                {
                    "exact_snippets": "Patients of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "practicing an effective form of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": "effective form"
                        }
                    ]
                }
            ]
        },
        {
            "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": "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 dalantercept or other inhibitor of the ALK1 pathway",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had prior therapy with dalantercept",
                    "criterion": "prior therapy with dalantercept",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other inhibitor of the ALK1 pathway",
                    "criterion": "prior therapy with other inhibitor of the ALK1 pathway",
                    "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, are excluded if there is any evidence of 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 other malignancy being present within the last three years",
                    "criterion": "evidence 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 type",
                            "expected_value": "endometrial cancer"
                        },
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "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",
                    "requirements": [
                        {
                            "requirement_type": "cancer type",
                            "expected_value": [
                                "breast",
                                "head and neck",
                                "skin"
                            ]
                        },
                        {
                            "requirement_type": "time since treatment",
                            "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": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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 are excluded",
                    "criterion": "prior chemotherapy for abdominal or pelvic tumor",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "cancer type",
                            "expected_value": {
                                "operator": "!=",
                                "value": 1,
                                "unit": "endometrial cancer"
                            }
                        }
                    ]
                },
                {
                    "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"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patient remains free of recurrent or metastatic disease",
                    "criterion": "recurrent or metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with history or evidence upon physical exam of central nervous system disease (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases or leptomeningeal disease",
            "criterions": [
                {
                    "exact_snippets": "history or evidence upon physical exam of central nervous system disease (CNS) disease",
                    "criterion": "central nervous system disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "primary brain tumor",
                    "criterion": "primary brain tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "seizures not controlled with standard medical therapy",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "control with standard medical therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious or non-healing wound, ulcer, or bone fracture",
            "criterions": [
                {
                    "exact_snippets": "Serious or non-healing wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcer",
                    "criterion": "ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bone fracture",
                    "criterion": "bone fracture",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of abdominal fistula or anastomotic leak, gastrointestinal perforation, or intra-abdominal abscess within 6 months of registration",
            "criterions": [
                {
                    "exact_snippets": "History of abdominal fistula",
                    "criterion": "abdominal fistula",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anastomotic leak",
                    "criterion": "anastomotic leak",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal perforation",
                    "criterion": "gastrointestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intra-abdominal abscess",
                    "criterion": "intra-abdominal abscess",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months of registration",
                    "criterion": "time since condition",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active bleeding (e.g., active hemoptysis, defined as bright red blood of greater than or equal to ½ teaspoon [2.5 ml] in any 24-hour period) within 2 weeks prior to registration or gastrointestinal bleeding within 3 months prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Active bleeding (e.g., active hemoptysis, defined as bright red blood of greater than or equal to ½ teaspoon [2.5 ml] in any 24-hour period) within 2 weeks prior to registration",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks prior to registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "gastrointestinal bleeding within 3 months prior to registration",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 months prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hereditary hemorrhagic telangiectasia (HHT)",
            "criterions": [
                {
                    "exact_snippets": "Hereditary hemorrhagic telangiectasia (HHT)",
                    "criterion": "Hereditary hemorrhagic telangiectasia (HHT)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet function abnormality",
            "criterions": [
                {
                    "exact_snippets": "Platelet function abnormality",
                    "criterion": "platelet function",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Autoimmune or hereditary hemolysis",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune ... hemolysis",
                    "criterion": "autoimmune hemolysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hereditary hemolysis",
                    "criterion": "hereditary hemolysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Coagulopathy, or",
            "criterions": [
                {
                    "exact_snippets": "Coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor involving major vessels (defined as any lesion invading or abutting the wall [i.e., no fat plane evident] of major blood vessels as assessed by CT or MRI)",
            "criterions": [
                {
                    "exact_snippets": "Tumor involving major vessels (defined as any lesion invading or abutting the wall [i.e., no fat plane evident] of major blood vessels as assessed by CT or MRI)",
                    "criterion": "tumor involvement with major vessels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving treatment with full-dose aspirin (325 mg oral daily), clopidogrel (Plavix), or dabigatran (Pradaxa)",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving treatment with full-dose aspirin (325 mg oral daily)",
                    "criterion": "aspirin treatment",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "=",
                                "value": 325,
                                "unit": "mg"
                            }
                        },
                        {
                            "requirement_type": "frequency",
                            "expected_value": "daily"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving treatment with ... clopidogrel (Plavix)",
                    "criterion": "clopidogrel treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving treatment with ... dabigatran (Pradaxa)",
                    "criterion": "dabigatran treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with peripheral edema greater than or equal to grade 1 within 4 weeks of registration",
            "criterions": [
                {
                    "exact_snippets": "peripheral edema greater than or equal to grade 1",
                    "criterion": "peripheral edema",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks of registration",
                    "criterion": "time since registration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients with clinically significant cardiovascular disease:",
            "criterions": [
                {
                    "exact_snippets": "clinically significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension, defined as systolic > 150 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension, defined as ... diastolic > 90 mm Hg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension, defined as ... despite antihypertensive medications",
                    "criterion": "hypertension control",
                    "requirements": [
                        {
                            "requirement_type": "treatment response",
                            "expected_value": "uncontrolled despite antihypertensive medications"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of hypertrophic cardiomyopathy",
            "criterions": [
                {
                    "exact_snippets": "Evidence of hypertrophic cardiomyopathy",
                    "criterion": "hypertrophic cardiomyopathy",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* New York Heart Association (NYHA) class II or greater congestive heart failure (CHF)",
            "criterions": [
                {
                    "exact_snippets": "New York Heart Association (NYHA) class II or greater",
                    "criterion": "NYHA class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure (CHF)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any of the following within 6 months prior to study registration:",
            "criterions": [
                {
                    "exact_snippets": "Any of the following within 6 months prior to study registration",
                    "criterion": "time since event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bypass surgery",
            "criterions": [
                {
                    "exact_snippets": "Bypass surgery",
                    "criterion": "bypass surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stent placement",
            "criterions": [
                {
                    "exact_snippets": "Stent placement",
                    "criterion": "stent placement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute coronary syndrome/unstable angina",
            "criterions": [
                {
                    "exact_snippets": "Acute coronary syndrome",
                    "criterion": "acute coronary syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hospitalization for congestive heart failure (CHF)",
            "criterions": [
                {
                    "exact_snippets": "Hospitalization for congestive heart failure (CHF)",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "hospitalization",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious cardiac arrhythmia requiring medication; this does not include asymptomatic atrial fibrillation with controlled ventricular rate",
            "criterions": [
                {
                    "exact_snippets": "Serious cardiac arrhythmia requiring medication",
                    "criterion": "serious cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "requiring medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic atrial fibrillation with controlled ventricular rate",
                    "criterion": "asymptomatic atrial fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        },
                        {
                            "requirement_type": "ventricular rate",
                            "expected_value": "controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prolonged QTc interval > 450 ms",
            "criterions": [
                {
                    "exact_snippets": "Prolonged QTc interval > 450 ms",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior anthracycline cumulative dose > 450 mg/m^2",
            "criterions": [
                {
                    "exact_snippets": "Prior anthracycline cumulative dose > 450 mg/m^2",
                    "criterion": "anthracycline cumulative dose",
                    "requirements": [
                        {
                            "requirement_type": "amount",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "mg/m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* History of syndrome of inappropriate antidiuretic hormone secretion (SIADH)",
            "criterions": [
                {
                    "exact_snippets": "History of syndrome of inappropriate antidiuretic hormone secretion (SIADH)",
                    "criterion": "syndrome of inappropriate antidiuretic hormone secretion (SIADH)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have undergone a therapeutic paracentesis within 4 weeks of registration",
            "criterions": [
                {
                    "exact_snippets": "therapeutic paracentesis within 4 weeks of registration",
                    "criterion": "therapeutic paracentesis",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), or HBV core antibody, or human immunodeficiency virus (HIV) antibody results",
            "criterions": [
                {
                    "exact_snippets": "Known history of positive hepatitis C virus (HCV) antibody",
                    "criterion": "hepatitis C virus (HCV) antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of positive ... hepatitis B virus (HBV) surface antigen (HBsAg)",
                    "criterion": "hepatitis B virus (HBV) surface antigen (HBsAg)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of positive ... HBV core antibody",
                    "criterion": "HBV core antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known history of positive ... human immunodeficiency virus (HIV) antibody",
                    "criterion": "human immunodeficiency virus (HIV) antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of severe (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v.4.0 >= grade 3) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients (10 mM Tris buffered saline) in the investigational agent",
            "criterions": [
                {
                    "exact_snippets": "History of severe (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v.4.0 >= grade 3) allergic or anaphylactic reaction",
                    "criterion": "allergic or anaphylactic reaction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "NCI-CTCAE v.4.0 grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of severe ... hypersensitivity to recombinant proteins or excipients (10 mM Tris buffered saline)",
                    "criterion": "hypersensitivity to recombinant proteins or excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant active pulmonary risk including pulmonary hypertension, pulmonary embolism, or history of pulmonary edema",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant active pulmonary risk including pulmonary hypertension",
                    "criterion": "pulmonary hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant active pulmonary risk including ... pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant active pulmonary risk including ... history of pulmonary edema",
                    "criterion": "history of pulmonary edema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients requiring parenteral hydration or parenteral/total parenteral nutrition",
            "criterions": [
                {
                    "exact_snippets": "Patients requiring parenteral hydration",
                    "criterion": "parenteral hydration",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients requiring parenteral/total parenteral nutrition",
                    "criterion": "parenteral nutrition",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No patients with:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}