{
    "info": {
        "nct_id": "NCT01106248",
        "official_title": "An Open-Label, Multicenter, Single Arm QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors",
        "inclusion_criteria": "1. Patients with histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy).\n2. Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy </= Grade 2 and alopecia.\n3. Age >/= 18 years.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n5. Patients must have a sinus rhythm and QRS < 120msec.\n6. Adequate renal function as evidenced by serum creatinine </= 2.0 mg/dL or calculated creatinine clearance >/= 40 mL/min per the Cockcroft and Gault formula.\n7. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >/= 1.5 x 10^9/L, hemoglobin >/= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count >/= 100 x 10^9/L.\n8. Adequate liver function as evidenced by bilirubin >/= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) </= 3 x ULN (in the case of liver metastases </= 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.\n9. Patients willing and able to comply with the study protocol for the duration of the study.\n10. Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.\nHealthy volunteers allowed",
        "exclusion_criteria": "1. Patients who have received any of the following treatments within the specified period before start of treatment with eribulin mesylate:\n\n   * Chemotherapy, radiation or biological therapy within three weeks\n   * Hormonal therapy within one week\n   * Any investigational drug within four weeks\n2. Have had radiation therapy encompassing > 30% of bone marrow.\n3. Have received prior treatment with mitomycin C or nitrosourea.\n4. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.\n5. Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g. radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.\n6. Patients with meningeal carcinomatosis.\n7. Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).\n8. Patients with marked baseline prolongation of QT/QTc interval (QTc interval > 500 msec).\n9. Patients with a history of additional risk factors for Torsades des pointes (e.g., heart failure, cardiac ischemia, recent Myocardial Infarction (MI), family history of Long QT Syndrome).\n10. Patients with uncontrolled metabolic disorders (e.g hypokalemia, hypercalcemia and hypomagnesemia) at entry to the study.\n11. Patients treated with antiarrythmic drugs or other medications that prolong the QT/QTc, that cannot be discontinued prior to entry into the study phase.\n12. Patients with implantable pacemaker or automatic implantable cardioverter defibrillator (AICD).\n13. .Bradycardia (defined as </= 50 beats/minute).\n14. Personal history of unexplained syncope within the last year prior to entry into the study.\n15. Patients with other significant disease or disorders that, in the Investigator's opinion, should exclude the patient from the study.\n16. Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.\n17. Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.\n18. Severe/uncontrolled intercurrent illness/infection.\n19. Patients with organ allografts requiring immunosuppression.\n20. Patients with known positive HIV status.\n21. Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >/= 5 years previously with no subsequent evidence of recurrence.\n22. Patients with pre-existing neuropathy > Grade 2.\n23. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.\n24. Patients who participated in a prior eribulin mesylate clinical trial.\n25. Patients with pericardial effusion or pericardial metastases.",
        "miscellaneous_criteria": "Personal history of unexplained syncope within the last year prior to entry"
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy).",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed advanced solid tumor",
                    "criterion": "advanced solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor that has progressed following standard therapy",
                    "criterion": "tumor progression",
                    "requirements": [
                        {
                            "requirement_type": "progression status",
                            "expected_value": "progressed following standard therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor ... for which no standard therapy exists",
                    "criterion": "availability of standard therapy",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy </= Grade 2 and alopecia.",
            "criterions": [
                {
                    "exact_snippets": "Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower",
                    "criterion": "chemotherapy or radiation-related toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for stable sensory neuropathy </= Grade 2",
                    "criterion": "stable sensory neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Age >/= 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age >/= 18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 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": "5. Patients must have a sinus rhythm and QRS < 120msec.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have a sinus rhythm",
                    "criterion": "sinus rhythm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "QRS < 120msec",
                    "criterion": "QRS duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 120,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate renal function as evidenced by serum creatinine </= 2.0 mg/dL or calculated creatinine clearance >/= 40 mL/min per the Cockcroft and Gault formula.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function as evidenced by serum creatinine </= 2.0 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate renal function ... calculated creatinine clearance >/= 40 mL/min",
                    "criterion": "calculated creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >/= 1.5 x 10^9/L, hemoglobin >/= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count >/= 100 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"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin >/= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10.0,
                                "unit": "g/dL"
                            }
                        },
                        {
                            "requirement_type": "correction",
                            "expected_value": "acceptable if it is corrected by growth factor or transfusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count >/= 100 x 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Adequate liver function as evidenced by bilirubin >/= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) </= 3 x ULN (in the case of liver metastases </= 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.",
            "criterions": [
                {
                    "exact_snippets": "bilirubin >/= 1.5 times the upper limits of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase ... </= 3 x ULN",
                    "criterion": "alkaline phosphatase level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) ... </= 3 x ULN",
                    "criterion": "alanine aminotransferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) </= 3 x ULN",
                    "criterion": "aspartate aminotransferase (AST) level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "in the case of liver metastases </= 5 x ULN",
                    "criterion": "liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase",
                    "criterion": "bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "liver specific alkaline phosphatase must be separated from the total"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients willing and able to comply with the study protocol for the duration of the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients willing and able to comply with the study protocol",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients who have received any of the following treatments within the specified period before start of treatment with eribulin mesylate:",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received any of the following treatments",
                    "criterion": "prior treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the specified period before start of treatment with eribulin mesylate",
                    "criterion": "time since prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "within the specified period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy, radiation or biological therapy within three weeks",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy, radiation or biological therapy within three weeks",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Chemotherapy, radiation or biological therapy within three weeks",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Chemotherapy, radiation or biological therapy within three weeks",
                    "criterion": "biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormonal therapy within one week",
            "criterions": [
                {
                    "exact_snippets": "Hormonal therapy within one week",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any investigational drug within four weeks",
            "criterions": [
                {
                    "exact_snippets": "Any investigational drug within four weeks",
                    "criterion": "investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Have had radiation therapy encompassing > 30% of bone marrow.",
            "criterions": [
                {
                    "exact_snippets": "radiation therapy encompassing > 30% of bone marrow",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "% of bone marrow"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have received prior treatment with mitomycin C or nitrosourea.",
            "criterions": [
                {
                    "exact_snippets": "received prior treatment with mitomycin C",
                    "criterion": "prior treatment with mitomycin C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received prior treatment with ... nitrosourea",
                    "criterion": "prior treatment with nitrosourea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary lymphangitic involvement",
                    "criterion": "pulmonary lymphangitic involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary dysfunction",
                    "criterion": "pulmonary dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring active treatment",
                    "criterion": "active treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of oxygen",
                    "criterion": "use of oxygen",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g. radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Patients with brain or subdural metastases are not eligible",
                    "criterion": "brain or subdural metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless they have completed local therapy",
                    "criterion": "local therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have discontinued the use of corticosteroids for this indication for at least 4 weeks",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any signs (e.g. radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks",
                    "criterion": "signs and/or symptoms of brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with meningeal carcinomatosis.",
            "criterions": [
                {
                    "exact_snippets": "Patients with meningeal carcinomatosis",
                    "criterion": "meningeal carcinomatosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).",
            "criterions": [
                {
                    "exact_snippets": "history of congestive heart failure > NYHA grade II",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NYHA grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the past six months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serious cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with marked baseline prolongation of QT/QTc interval (QTc interval > 500 msec).",
            "criterions": [
                {
                    "exact_snippets": "marked baseline prolongation of QT/QTc interval",
                    "criterion": "QT/QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "prolongation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "QTc interval > 500 msec",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 500,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with a history of additional risk factors for Torsades des pointes (e.g., heart failure, cardiac ischemia, recent Myocardial Infarction (MI), family history of Long QT Syndrome).",
            "criterions": [
                {
                    "exact_snippets": "history of additional risk factors for Torsades des pointes ... heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of additional risk factors for Torsades des pointes ... cardiac ischemia",
                    "criterion": "cardiac ischemia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of additional risk factors for Torsades des pointes ... recent Myocardial Infarction (MI)",
                    "criterion": "recent Myocardial Infarction (MI)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of additional risk factors for Torsades des pointes ... family history of Long QT Syndrome",
                    "criterion": "family history of Long QT Syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients with uncontrolled metabolic disorders (e.g hypokalemia, hypercalcemia and hypomagnesemia) at entry to the study.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled metabolic disorders (e.g hypokalemia, hypercalcemia and hypomagnesemia)",
                    "criterion": "metabolic disorders",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "hypokalemia",
                    "criterion": "hypokalemia",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "hypercalcemia",
                    "criterion": "hypercalcemia",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "hypomagnesemia",
                    "criterion": "hypomagnesemia",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients treated with antiarrythmic drugs or other medications that prolong the QT/QTc, that cannot be discontinued prior to entry into the study phase.",
            "criterions": [
                {
                    "exact_snippets": "Patients treated with antiarrythmic drugs",
                    "criterion": "antiarrythmic drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medications that prolong the QT/QTc",
                    "criterion": "medications that prolong QT/QTc",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be discontinued prior to entry into the study phase",
                    "criterion": "medication discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patients with implantable pacemaker or automatic implantable cardioverter defibrillator (AICD).",
            "criterions": [
                {
                    "exact_snippets": "Patients with implantable pacemaker",
                    "criterion": "implantable pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "automatic implantable cardioverter defibrillator (AICD)",
                    "criterion": "automatic implantable cardioverter defibrillator (AICD)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. .Bradycardia (defined as </= 50 beats/minute).",
            "criterions": [
                {
                    "exact_snippets": "Bradycardia (defined as </= 50 beats/minute)",
                    "criterion": "bradycardia",
                    "requirements": [
                        {
                            "requirement_type": "heart rate",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "beats/minute"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Personal history of unexplained syncope within the last year prior to entry into the study.",
            "criterions": [
                {
                    "exact_snippets": "Personal history of unexplained syncope within the last year",
                    "criterion": "unexplained syncope",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last year"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients with other significant disease or disorders that, in the Investigator's opinion, should exclude the patient from the study.",
            "criterions": [
                {
                    "exact_snippets": "other significant disease or disorders",
                    "criterion": "significant disease or disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are receiving anti-coagulant therapy with warfarin or related compounds",
                    "criterion": "anti-coagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": [
                                "warfarin",
                                "related compounds"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be changed to heparin-based therapy",
                    "criterion": "ability to change therapy",
                    "requirements": [
                        {
                            "requirement_type": "changeability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored",
                    "criterion": "prothrombin time (PT) or international normalized ratio (INR) monitoring",
                    "requirements": [
                        {
                            "requirement_type": "monitoring",
                            "expected_value": "closely"
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential with either a positive pregnancy test at screening",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential with ... no pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential unless (1) surgically sterile",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential unless ... (2) using adequate measures of contraception in the opinion of the Investigator",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential",
                    "criterion": "amenorrhea duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Severe/uncontrolled intercurrent illness/infection.",
            "criterions": [
                {
                    "exact_snippets": "Severe/uncontrolled intercurrent illness/infection",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe/uncontrolled intercurrent illness/infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Patients with organ allografts requiring immunosuppression.",
            "criterions": [
                {
                    "exact_snippets": "organ allografts",
                    "criterion": "organ allografts",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring immunosuppression",
                    "criterion": "immunosuppression",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Patients with known positive HIV status.",
            "criterions": [
                {
                    "exact_snippets": "known positive HIV status",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >/= 5 years previously with no subsequent evidence of recurrence.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had a prior malignancy",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other than carcinoma in situ of the cervix, or non-melanoma skin cancer",
                    "criterion": "type of prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "carcinoma in situ of the cervix",
                                "non-melanoma skin cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the prior malignancy was diagnosed and definitively treated >/= 5 years previously",
                    "criterion": "time since treatment of prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with no subsequent evidence of recurrence",
                    "criterion": "recurrence of prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "evidence of recurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Patients with pre-existing neuropathy > Grade 2.",
            "criterions": [
                {
                    "exact_snippets": "pre-existing neuropathy > Grade 2",
                    "criterion": "pre-existing neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity to halichondrin B",
                    "criterion": "hypersensitivity to halichondrin B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... halichondrin B chemical derivative",
                    "criterion": "hypersensitivity to halichondrin B chemical derivative",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "24. Patients who participated in a prior eribulin mesylate clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Patients who participated in a prior eribulin mesylate clinical trial",
                    "criterion": "prior participation in eribulin mesylate clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "25. Patients with pericardial effusion or pericardial metastases.",
            "criterions": [
                {
                    "exact_snippets": "pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pericardial metastases",
                    "criterion": "pericardial metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Personal history of unexplained syncope within the last year prior to entry",
            "criterions": [
                {
                    "exact_snippets": "Personal history of unexplained syncope within the last year",
                    "criterion": "unexplained syncope",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last year"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}