{
    "info": {
        "nct_id": "NCT01012362",
        "official_title": "Phase I Study of Pazopanib and Ixabepilone in Patients With Solid Tumors",
        "inclusion_criteria": "* Diagnosis of advanced non-hematologic solid tumor malignancy, including, but not limited to breast, lung, colon, pancreatic, head and neck, kidney or sarcoma that has failed or become intolerant to standard therapy and is no longer likely to respond to such therapy Effective with the August 2011 version of the protocol, enrollment is limited to squamous cell carcinoma of the head and neck (refer to section 1.4 for rationale). Note: Patients with a primary diagnosis of hepatocellular carcinoma will be eligible for enrollment into dose level 1 or 2 only, provided they met all other inclusion/exclusion criteria - the maximum tolerated dose (MTD) for pazopanib monotherapy in patients with hepatocellular cancer was found to be 600 mg daily.\n* Measureable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST).\n* Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed; however prior use of either pazopanib or ixabepilone alone or in combination is not allowed.\n* At least 14 days must have elapsed since 1) previous systemic therapy (28 days for bevacizumab) before the 1st dose of study drug, 2) last dose of radiation therapy or surgery (28 days for major surgery).\n* Patient must have recovered from the acute toxic effects of previous anti-cancer treatment prior to study enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Adequate organ function within 14 days of enrollment defined as:\n\n  * Absolute neutrophil count (ANC) >1.5 x 10^9/L\n  * Hemoglobin > or = 9 g/dL\n  * Platelets > or = 100 x 10^9/L\n  * Prothrombin time or international normalized ratio, and partial thromboplastin time (PTT) < or = 1.2 x upper limit of normal (ULN)\n  * Total bilirubin < or = ULN\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = 2.5 x ULN\n  * Serum creatinine < or = 1.5 mg/dL\n  * Urine protein to Creatinine Ratio < 1\n  * Total serum calcium < 12.0 mg/dL\n* Men and women with child-bearing potential must adhere to protocol criteria to prevent conception during study\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Women who are pregnant or nursing.\n* Prior radiation to > =or = 30% of major bone marrow containing areas (pelvis, lumbar spine)\n* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis\n* Clinically significant gastrointestinal abnormalities that may increase the risk of GI bleeding or may affect absorption of investigational product\n* History of another malignancy - must be at least 3 years disease-free\n* Presence of uncontrolled infection\n* Prolongation of corrected QT interval (QTc) > 480 msecs\n* History of any one or more of the following cardiovascular conditions within the past 6 months:\n\n  * Cardiac angioplasty or stenting\n  * Myocardial infarction\n  * Unstable angina\n  * Coronary artery bypass graft surgery\n  * Symptomatic peripheral vascular disease\n  * Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)\n* Poorly controlled hypertension\n* History of cerebrovascular accident,pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months\n* Prior major surgery or trauma within 28 days prior to 1st dose of study drug\n* Evidence of active bleeding or bleeding diathesis\n* Known endobronchial lesions or involvement of large pulmonary vessels by tumor\n* Hemoptysis with 6 weeks of 1st dose of study drug\n* Neuropathy Grade 1",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Diagnosis of advanced non-hematologic solid tumor malignancy, including, but not limited to breast, lung, colon, pancreatic, head and neck, kidney or sarcoma that has failed or become intolerant to standard therapy and is no longer likely to respond to such therapy Effective with the August 2011 version of the protocol, enrollment is limited to squamous cell carcinoma of the head and neck (refer to section 1.4 for rationale). Note: Patients with a primary diagnosis of hepatocellular carcinoma will be eligible for enrollment into dose level 1 or 2 only, provided they met all other inclusion/exclusion criteria - the maximum tolerated dose (MTD) for pazopanib monotherapy in patients with hepatocellular cancer was found to be 600 mg daily.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of advanced non-hematologic solid tumor malignancy",
                    "criterion": "advanced non-hematologic solid tumor malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including, but not limited to breast, lung, colon, pancreatic, head and neck, kidney or sarcoma",
                    "criterion": "specific tumor types",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "breast",
                                "lung",
                                "colon",
                                "pancreatic",
                                "head and neck",
                                "kidney",
                                "sarcoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "that has failed or become intolerant to standard therapy and is no longer likely to respond to such therapy",
                    "criterion": "response to standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "failure or intolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "enrollment is limited to squamous cell carcinoma of the head and neck",
                    "criterion": "squamous cell carcinoma of the head and neck",
                    "requirements": [
                        {
                            "requirement_type": "enrollment limitation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with a primary diagnosis of hepatocellular carcinoma will be eligible for enrollment into dose level 1 or 2 only",
                    "criterion": "hepatocellular carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "enrollment eligibility",
                            "expected_value": "dose level 1 or 2 only"
                        }
                    ]
                },
                {
                    "exact_snippets": "the maximum tolerated dose (MTD) for pazopanib monotherapy in patients with hepatocellular cancer was found to be 600 mg daily",
                    "criterion": "maximum tolerated dose for pazopanib",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "=",
                                "value": 600,
                                "unit": "mg daily"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measureable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST).",
            "criterions": [
                {
                    "exact_snippets": "Measureable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST).",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        },
                        {
                            "requirement_type": "evaluation_criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed; however prior use of either pazopanib or ixabepilone alone or in combination is not allowed.",
            "criterions": [
                {
                    "exact_snippets": "Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed",
                    "criterion": "prior systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "chemotherapy",
                                "immunotherapy",
                                "biological therapy"
                            ]
                        },
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior use of either pazopanib or ixabepilone alone or in combination is not allowed",
                    "criterion": "prior use of pazopanib or ixabepilone",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 14 days must have elapsed since 1) previous systemic therapy (28 days for bevacizumab) before the 1st dose of study drug, 2) last dose of radiation therapy or surgery (28 days for major surgery).",
            "criterions": [
                {
                    "exact_snippets": "At least 14 days must have elapsed since ... previous systemic therapy",
                    "criterion": "elapsed time since previous systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least ... 28 days for bevacizumab",
                    "criterion": "elapsed time since previous bevacizumab therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 14 days must have elapsed since ... last dose of radiation therapy",
                    "criterion": "elapsed time since last dose of radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 14 days must have elapsed since ... surgery",
                    "criterion": "elapsed time since surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least ... 28 days for major surgery",
                    "criterion": "elapsed time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have recovered from the acute toxic effects of previous anti-cancer treatment prior to study enrollment.",
            "criterions": [
                {
                    "exact_snippets": "recovered from the acute toxic effects of previous anti-cancer treatment",
                    "criterion": "recovery from acute toxic effects",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function within 14 days of enrollment defined as:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days of enrollment",
                    "criterion": "timeframe for organ function assessment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) >1.5 x 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) >1.5 x 10^9/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin > or = 9 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > or = 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets > or = 100 x 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "Platelets > or = 100 x 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prothrombin time or international normalized ratio, and partial thromboplastin time (PTT) < or = 1.2 x upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Prothrombin time or international normalized ratio ... < or = 1.2 x upper limit of normal (ULN)",
                    "criterion": "prothrombin time or international normalized ratio",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "partial thromboplastin time (PTT) < or = 1.2 x upper limit of normal (ULN)",
                    "criterion": "partial thromboplastin time (PTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin < or = ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin < or = ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine < or = 1.5 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine < or = 1.5 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urine protein to Creatinine Ratio < 1",
            "criterions": [
                {
                    "exact_snippets": "Urine protein to Creatinine Ratio < 1",
                    "criterion": "Urine protein to Creatinine Ratio",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total serum calcium < 12.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Total serum calcium < 12.0 mg/dL",
                    "criterion": "total serum calcium",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 12.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men and women with child-bearing potential must adhere to protocol criteria to prevent conception during study",
            "criterions": [
                {
                    "exact_snippets": "Men and women with child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adhere to protocol criteria to prevent conception during study",
                    "criterion": "adherence to protocol criteria to prevent conception",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Women who are pregnant or nursing.",
            "criterions": [
                {
                    "exact_snippets": "Women 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": "* Prior radiation to > =or = 30% of major bone marrow containing areas (pelvis, lumbar spine)",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation to > =or = 30% of major bone marrow containing areas (pelvis, lumbar spine)",
                    "criterion": "prior radiation to major bone marrow containing areas",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "pelvis",
                                "lumbar spine"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis",
            "criterions": [
                {
                    "exact_snippets": "History or clinical evidence of central nervous system (CNS) metastases",
                    "criterion": "central nervous system (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History or clinical evidence of ... leptomeningeal carcinomatosis",
                    "criterion": "leptomeningeal carcinomatosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant gastrointestinal abnormalities that may increase the risk of GI bleeding or may affect absorption of investigational product",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant gastrointestinal abnormalities",
                    "criterion": "gastrointestinal abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "may increase the risk of GI bleeding",
                    "criterion": "risk of GI bleeding",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increased"
                        }
                    ]
                },
                {
                    "exact_snippets": "may affect absorption of investigational product",
                    "criterion": "absorption of investigational product",
                    "requirements": [
                        {
                            "requirement_type": "effect",
                            "expected_value": "may affect"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of another malignancy - must be at least 3 years disease-free",
            "criterions": [
                {
                    "exact_snippets": "History of another malignancy - must be at least 3 years disease-free",
                    "criterion": "history of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "Presence of uncontrolled infection",
                    "criterion": "uncontrolled infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prolongation of corrected QT interval (QTc) > 480 msecs",
            "criterions": [
                {
                    "exact_snippets": "Prolongation of corrected QT interval (QTc) > 480 msecs",
                    "criterion": "corrected QT interval (QTc)",
                    "requirements": [
                        {
                            "requirement_type": "prolongation",
                            "expected_value": {
                                "operator": ">",
                                "value": 480,
                                "unit": "msecs"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of any one or more of the following cardiovascular conditions within the past 6 months:",
            "criterions": [
                {
                    "exact_snippets": "History of any one or more of the following cardiovascular conditions within the past 6 months",
                    "criterion": "cardiovascular conditions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac angioplasty or stenting",
            "criterions": [
                {
                    "exact_snippets": "Cardiac angioplasty",
                    "criterion": "cardiac angioplasty",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stenting",
                    "criterion": "stenting",
                    "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": "* Unstable angina",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Coronary artery bypass graft surgery",
            "criterions": [
                {
                    "exact_snippets": "Coronary artery bypass graft surgery",
                    "criterion": "coronary artery bypass graft surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic peripheral vascular disease",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic peripheral vascular disease",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)",
            "criterions": [
                {
                    "exact_snippets": "Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled hypertension",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of cerebrovascular accident,pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "History of cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated deep venous thrombosis (DVT)",
                    "criterion": "untreated deep venous thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 6 months",
                    "criterion": "time frame for conditions",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior major surgery or trauma within 28 days prior to 1st dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Prior major surgery or trauma within 28 days prior to 1st dose of study drug",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior major surgery or trauma within 28 days prior to 1st dose of study drug",
                    "criterion": "trauma",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of active bleeding or bleeding diathesis",
            "criterions": [
                {
                    "exact_snippets": "Evidence of active bleeding",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known endobronchial lesions or involvement of large pulmonary vessels by tumor",
            "criterions": [
                {
                    "exact_snippets": "Known endobronchial lesions",
                    "criterion": "endobronchial lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "involvement of large pulmonary vessels by tumor",
                    "criterion": "involvement of large pulmonary vessels by tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoptysis with 6 weeks of 1st dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Hemoptysis",
                    "criterion": "hemoptysis",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 6 weeks of 1st dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neuropathy Grade 1",
            "criterions": [
                {
                    "exact_snippets": "Neuropathy Grade 1",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "Grade 1"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = 2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) < or = 2.5 x ULN",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) < or = 2.5 x ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}