{
    "info": {
        "nct_id": "NCT00764972",
        "official_title": "A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer",
        "inclusion_criteria": "* Women affected by histologically proven metastatic breast cancer.\n* Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2 amplification or immunohistochemistry 0-1+ for HER-2 expression.\n* Female, age ≥ 18.\n* Documented measurable disease by appropriate radiologic imaging according to RECIST criteria (see Appendix E). Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation.\n* ECOG performance status 0-1 (see Appendix B)\n* Life expectancy > 6 months.\n* Adequate bone marrow function, as indicated by:\n\n  * Hemoglobin ≥ 90 g/L\n  * Neutrophils ≥ 1.5 x 109/L\n  * Platelets ≥ 100 x 109/L\n* Adequate renal function, as indicated by serum creatinine ≤1.5 times the upper limit of normal and/or Creatinine Clearance calculated as >50% lower normal limit, or estimated as ≥ 50 ml/min (Appendix C).\n* Adequate liver function, as indicated by:\n\n  * bilirubin ≤ 1.5 times upper normal limit;\n  * AST and ALT ≤ 2 times upper normal limit.\n* Left ventricular ejection fraction (LVEF) ≥50% as measured by either multigated acquisition (MUGA) scan or echocardiogram (ECHO).\n* No therapy for breast cancer in the 4 weeks preceding the therapy start.\n* Women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment.\n* Patient able to understand and give written informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 19 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Patients with locally advanced breast cancer or stage IIIb only.\n* Presence of only non-measurable disease.\n* Previous (neo)adjuvant chemotherapy with vinorelbine.\n* Any previous anti-angiogenic therapy.\n* Any previous chemotherapy for metastatic breast cancer. Previous hormonal treatments or radiotherapy for metastatic disease are allowed.\n* Radiotherapy, chemotherapy or hormonal therapy for breast cancer in the last 4 weeks prior to starting the study treatment.\n* Major surgery within 4 weeks of first study treatment, or minor surgery (including placement of an access device) within 7 days of therapy start.\n* Presence of life-threatening disease or central nervous system localizations.\n* Evidence of HER-2 positive breast cancer, defined as FISH-positive for amplification or score 3+ by immunohistochemistry.\n* Any other possibly active primary tumor, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Clinically significant hepatic disease with respect to hepatitis B, hepatitis C, cirrhosis or other liver diseases.\n* Uncontrolled bacterial, viral or fungal infection.\n* Previous history of ischemic disease.\n* Patients with previous history of thrombo-embolic events, or with documented risk factors for thrombotic disease other than cancer.\n* History of gross hemorrhage within the past 6 months (e.g., hemoptysis or hematuria requiring medical intervention).\n* Uncontrolled hypertension.\n* Other serious medical conditions, such as uncontrolled cardiac disease, severe pulmonary disease, uncontrolled diabetes.\n* Patient exhibiting confusion or disorientation.\n* Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.\n* Patient is pregnant, or is breast-feeding, or is unwilling to use adequate contraception.\n* Failure to give informed consent.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Women affected by histologically proven metastatic breast cancer.",
                "criterions": [
                    {
                        "exact_snippets": "Women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "histologically proven metastatic breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "histological proof",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "histologically proven metastatic breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "metastatic",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "histologically proven metastatic breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "histological proof",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "histologically proven metastatic breast cancer",
                                "criterion": "breast cancer",
                                "requirement": {
                                    "requirement_type": "metastatic",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2 amplification or immunohistochemistry 0-1+ for HER-2 expression.",
                "criterions": [
                    {
                        "exact_snippets": "Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2 amplification",
                        "criterion": "HER-2 amplification",
                        "requirement": {
                            "requirement_type": "FISH status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "immunohistochemistry 0-1+ for HER-2 expression",
                        "criterion": "HER-2 expression",
                        "requirement": {
                            "requirement_type": "immunohistochemistry score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "+"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Tumor not susceptible to therapy with trastuzumab, defined as FISH negative for HER-2 amplification",
                                "criterion": "HER-2 amplification",
                                "requirement": {
                                    "requirement_type": "FISH status",
                                    "expected_value": "negative"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "immunohistochemistry 0-1+ for HER-2 expression",
                                "criterion": "HER-2 expression",
                                "requirement": {
                                    "requirement_type": "immunohistochemistry score",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 0,
                                                "unit": "N/A"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "+"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Female, age ≥ 18.",
                "criterions": [
                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "age ≥ 18",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Documented measurable disease by appropriate radiologic imaging according to RECIST criteria (see Appendix E). Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation.",
                "criterions": [
                    {
                        "exact_snippets": "Documented measurable disease by appropriate radiologic imaging according to RECIST criteria",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Documented measurable disease by appropriate radiologic imaging according to RECIST criteria",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "appropriate radiologic imaging"
                        }
                    },
                    {
                        "exact_snippets": "Documented measurable disease by appropriate radiologic imaging according to RECIST criteria",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST"
                        }
                    },
                    {
                        "exact_snippets": "Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation",
                        "criterion": "lesions in previously irradiated areas",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation",
                        "criterion": "lesions in previously irradiated areas",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "unless progression has been documented post-radiation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Documented measurable disease by appropriate radiologic imaging according to RECIST criteria",
                                        "criterion": "measurable disease",
                                        "requirement": {
                                            "requirement_type": "documentation",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Documented measurable disease by appropriate radiologic imaging according to RECIST criteria",
                                        "criterion": "measurable disease",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "appropriate radiologic imaging"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Documented measurable disease by appropriate radiologic imaging according to RECIST criteria",
                                "criterion": "measurable disease",
                                "requirement": {
                                    "requirement_type": "criteria",
                                    "expected_value": "RECIST"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation",
                                "criterion": "lesions in previously irradiated areas",
                                "requirement": {
                                    "requirement_type": "measurability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Lesions in previously irradiated areas are not considered measurable disease, unless progression has been documented post-radiation",
                                "criterion": "lesions in previously irradiated areas",
                                "requirement": {
                                    "requirement_type": "condition",
                                    "expected_value": "unless progression has been documented post-radiation"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* ECOG performance status 0-1 (see Appendix B)",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Life expectancy > 6 months.",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy > 6 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy > 6 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate bone marrow function, as indicated by:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate bone marrow function",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate liver function, as indicated by:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate liver function",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* AST and ALT ≤ 2 times upper normal limit.",
                "criterions": [
                    {
                        "exact_snippets": "AST ... ≤ 2 times upper normal limit",
                        "criterion": "AST",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times upper normal limit"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT ≤ 2 times upper normal limit",
                        "criterion": "ALT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times upper normal limit"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "AST ... ≤ 2 times upper normal limit",
                        "criterion": "AST",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times upper normal limit"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT ≤ 2 times upper normal limit",
                        "criterion": "ALT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "times upper normal limit"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No therapy for breast cancer in the 4 weeks preceding the therapy start.",
                "criterions": [
                    {
                        "exact_snippets": "No therapy for breast cancer in the 4 weeks preceding the therapy start.",
                        "criterion": "therapy for breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No therapy for breast cancer in the 4 weeks preceding the therapy start.",
                        "criterion": "therapy for breast cancer",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No therapy for breast cancer in the 4 weeks preceding the therapy start.",
                        "criterion": "therapy for breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No therapy for breast cancer in the 4 weeks preceding the therapy start.",
                        "criterion": "therapy for breast cancer",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "Women of childbearing potential",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must be using adequate contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "have a negative pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Women of childbearing potential",
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                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "must be using adequate contraception",
                            "criterion": "contraception use",
                            "requirement": {
                                "requirement_type": "adequacy",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "have a negative pregnancy test",
                            "criterion": "pregnancy test",
                            "requirement": {
                                "requirement_type": "result",
                                "expected_value": "negative"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Patient able to understand and give written informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Patient able to understand",
                        "criterion": "patient understanding",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "give written informed consent",
                        "criterion": "written informed consent",
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                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Patient able to understand",
                        "criterion": "patient understanding",
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                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
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                        "exact_snippets": "give written informed consent",
                        "criterion": "written informed consent",
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                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
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                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 19 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 19 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 19 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 65 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 65 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 65 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients with locally advanced breast cancer or stage IIIb only.",
                "criterions": [
                    {
                        "exact_snippets": "locally advanced breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    },
                    {
                        "exact_snippets": "stage IIIb only",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IIIb"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "locally advanced breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    },
                    {
                        "exact_snippets": "stage IIIb only",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IIIb"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Presence of only non-measurable disease.",
                "criterions": [
                    {
                        "exact_snippets": "Presence of only non-measurable disease.",
                        "criterion": "non-measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Presence of only non-measurable disease.",
                    "criterion": "non-measurable disease",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Previous (neo)adjuvant chemotherapy with vinorelbine.",
                "criterions": [
                    {
                        "exact_snippets": "Previous (neo)adjuvant chemotherapy with vinorelbine.",
                        "criterion": "(neo)adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "drug",
                            "expected_value": "vinorelbine"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previous (neo)adjuvant chemotherapy with vinorelbine.",
                        "criterion": "(neo)adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "drug",
                            "expected_value": "vinorelbine"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any previous anti-angiogenic therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Any previous anti-angiogenic therapy.",
                        "criterion": "anti-angiogenic therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Any previous anti-angiogenic therapy.",
                    "criterion": "anti-angiogenic therapy",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any previous chemotherapy for metastatic breast cancer. Previous hormonal treatments or radiotherapy for metastatic disease are allowed.",
                "criterions": [
                    {
                        "exact_snippets": "previous chemotherapy for metastatic breast cancer",
                        "criterion": "previous chemotherapy",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "metastatic breast cancer"
                        }
                    },
                    {
                        "exact_snippets": "Previous hormonal treatments ... are allowed",
                        "criterion": "previous hormonal treatments",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "metastatic disease"
                        }
                    },
                    {
                        "exact_snippets": "Previous ... radiotherapy for metastatic disease are allowed",
                        "criterion": "previous radiotherapy",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "metastatic disease"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "previous chemotherapy for metastatic breast cancer",
                            "criterion": "previous chemotherapy",
                            "requirement": {
                                "requirement_type": "condition",
                                "expected_value": "metastatic breast cancer"
                            }
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Previous hormonal treatments ... are allowed",
                                "criterion": "previous hormonal treatments",
                                "requirement": {
                                    "requirement_type": "condition",
                                    "expected_value": "metastatic disease"
                                }
                            },
                            {
                                "exact_snippets": "Previous ... radiotherapy for metastatic disease are allowed",
                                "criterion": "previous radiotherapy",
                                "requirement": {
                                    "requirement_type": "condition",
                                    "expected_value": "metastatic disease"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Radiotherapy, chemotherapy or hormonal therapy for breast cancer in the last 4 weeks prior to starting the study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Radiotherapy ... in the last 4 weeks prior to starting the study treatment.",
                        "criterion": "radiotherapy for breast cancer",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "chemotherapy ... in the last 4 weeks prior to starting the study treatment.",
                        "criterion": "chemotherapy for breast cancer",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hormonal therapy for breast cancer in the last 4 weeks prior to starting the study treatment.",
                        "criterion": "hormonal therapy for breast cancer",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Radiotherapy ... in the last 4 weeks prior to starting the study treatment.",
                                "criterion": "radiotherapy for breast cancer",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "chemotherapy ... in the last 4 weeks prior to starting the study treatment.",
                                "criterion": "chemotherapy for breast cancer",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "hormonal therapy for breast cancer in the last 4 weeks prior to starting the study treatment.",
                                "criterion": "hormonal therapy for breast cancer",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major surgery within 4 weeks of first study treatment, or minor surgery (including placement of an access device) within 7 days of therapy start.",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery within 4 weeks of first study treatment",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "minor surgery (including placement of an access device) within 7 days of therapy start",
                        "criterion": "minor surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Major surgery within 4 weeks of first study treatment",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "minor surgery (including placement of an access device) within 7 days of therapy start",
                        "criterion": "minor surgery",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Presence of life-threatening disease or central nervous system localizations.",
                "criterions": [
                    {
                        "exact_snippets": "Presence of life-threatening disease",
                        "criterion": "life-threatening disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "central nervous system localizations",
                        "criterion": "central nervous system localizations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Presence of life-threatening disease",
                        "criterion": "life-threatening disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "central nervous system localizations",
                        "criterion": "central nervous system localizations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evidence of HER-2 positive breast cancer, defined as FISH-positive for amplification or score 3+ by immunohistochemistry.",
                "criterions": [
                    {
                        "exact_snippets": "HER-2 positive breast cancer",
                        "criterion": "HER-2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "FISH-positive for amplification",
                        "criterion": "FISH test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive for amplification"
                        }
                    },
                    {
                        "exact_snippets": "score 3+ by immunohistochemistry",
                        "criterion": "immunohistochemistry score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": ">= 3"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "HER-2 positive breast cancer",
                        "criterion": "HER-2 status",
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                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "FISH-positive for amplification",
                                "criterion": "FISH test",
                                "requirement": {
                                    "requirement_type": "result",
                                    "expected_value": "positive for amplification"
                                }
                            },
                            {
                                "exact_snippets": "score 3+ by immunohistochemistry",
                                "criterion": "immunohistochemistry score",
                                "requirement": {
                                    "requirement_type": "score",
                                    "expected_value": ">= 3"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any other possibly active primary tumor, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix.",
                "criterions": [
                    {
                        "exact_snippets": "Any other possibly active primary tumor",
                        "criterion": "active primary tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "except basal cell carcinoma of the skin",
                        "criterion": "basal cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except ... carcinoma in situ of the cervix",
                        "criterion": "carcinoma in situ of the cervix",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any other possibly active primary tumor",
                                "criterion": "active primary tumor",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "except basal cell carcinoma of the skin",
                                    "criterion": "basal cell carcinoma of the skin",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                                    "criterion": "carcinoma in situ of the cervix",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any other possibly active primary tumor",
                                "criterion": "active primary tumor",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "except basal cell carcinoma of the skin",
                                        "criterion": "basal cell carcinoma of the skin",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "except ... carcinoma in situ of the cervix",
                                        "criterion": "carcinoma in situ of the cervix",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinically significant hepatic disease with respect to hepatitis B, hepatitis C, cirrhosis or other liver diseases.",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant hepatic disease ... hepatitis B",
                        "criterion": "hepatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "hepatitis B"
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant hepatic disease ... hepatitis C",
                        "criterion": "hepatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "hepatitis C"
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant hepatic disease ... cirrhosis",
                        "criterion": "hepatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "cirrhosis"
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant hepatic disease ... other liver diseases",
                        "criterion": "hepatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "other liver diseases"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Clinically significant hepatic disease ... hepatitis B",
                        "criterion": "hepatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "hepatitis B"
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant hepatic disease ... hepatitis C",
                        "criterion": "hepatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "hepatitis C"
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant hepatic disease ... cirrhosis",
                        "criterion": "hepatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "cirrhosis"
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant hepatic disease ... other liver diseases",
                        "criterion": "hepatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "other liver diseases"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled bacterial, viral or fungal infection.",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled bacterial ... infection.",
                        "criterion": "bacterial infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled ... viral ... infection.",
                        "criterion": "viral infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled ... fungal infection.",
                        "criterion": "fungal infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Uncontrolled bacterial ... infection.",
                        "criterion": "bacterial infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled ... viral ... infection.",
                        "criterion": "viral infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled ... fungal infection.",
                        "criterion": "fungal infection",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Previous history of ischemic disease.",
                "criterions": [
                    {
                        "exact_snippets": "Previous history of ischemic disease",
                        "criterion": "ischemic disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previous history of ischemic disease",
                        "criterion": "ischemic disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with previous history of thrombo-embolic events, or with documented risk factors for thrombotic disease other than cancer.",
                "criterions": [
                    {
                        "exact_snippets": "previous history of thrombo-embolic events",
                        "criterion": "thrombo-embolic events",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "documented risk factors for thrombotic disease other than cancer",
                        "criterion": "risk factors for thrombotic disease",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "documented risk factors for thrombotic disease other than cancer",
                        "criterion": "risk factors for thrombotic disease",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": "cancer"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "documented risk factors for thrombotic disease other than cancer",
                                "criterion": "risk factors for thrombotic disease",
                                "requirement": {
                                    "requirement_type": "documentation",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "documented risk factors for thrombotic disease other than cancer",
                                "criterion": "risk factors for thrombotic disease",
                                "requirement": {
                                    "requirement_type": "exclusion",
                                    "expected_value": "cancer"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "previous history of thrombo-embolic events",
                        "criterion": "thrombo-embolic events",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of gross hemorrhage within the past 6 months (e.g., hemoptysis or hematuria requiring medical intervention).",
                "criterions": [
                    {
                        "exact_snippets": "History of gross hemorrhage within the past 6 months",
                        "criterion": "gross hemorrhage",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": "within the past 6 months"
                        }
                    },
                    {
                        "exact_snippets": "hemoptysis",
                        "criterion": "hemoptysis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hematuria requiring medical intervention",
                        "criterion": "hematuria",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "requiring medical intervention"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "History of gross hemorrhage within the past 6 months",
                                        "criterion": "gross hemorrhage",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": "within the past 6 months"
                                        }
                                    },
                                    {
                                        "exact_snippets": "hemoptysis",
                                        "criterion": "hemoptysis",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "gross hemorrhage",
                                        "criterion": "gross hemorrhage",
                                        "requirement": {
                                            "requirement_type": "history",
                                            "expected_value": "within the past 6 months"
                                        }
                                    },
                                    {
                                        "exact_snippets": "hematuria requiring medical intervention",
                                        "criterion": "hematuria",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": "requiring medical intervention"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled hypertension.",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirement": {
                        "requirement_type": "control",
                        "expected_value": "uncontrolled"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Other serious medical conditions, such as uncontrolled cardiac disease, severe pulmonary disease, uncontrolled diabetes.",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled cardiac disease",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "severe pulmonary disease",
                        "criterion": "pulmonary disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "uncontrolled cardiac disease",
                        "criterion": "cardiac disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "severe pulmonary disease",
                        "criterion": "pulmonary disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled diabetes",
                        "criterion": "diabetes",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient exhibiting confusion or disorientation.",
                "criterions": [
                    {
                        "exact_snippets": "Patient exhibiting confusion",
                        "criterion": "confusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient exhibiting ... disorientation",
                        "criterion": "disorientation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Patient exhibiting confusion",
                        "criterion": "confusion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patient exhibiting ... disorientation",
                        "criterion": "disorientation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient is pregnant, or is breast-feeding, or is unwilling to use adequate contraception.",
                "criterions": [
                    {
                        "exact_snippets": "Patient is pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "is breast-feeding",
                        "criterion": "breast-feeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "is unwilling to use adequate contraception",
                        "criterion": "use of adequate contraception",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patient is pregnant",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "is breast-feeding",
                                "criterion": "breast-feeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "is unwilling to use adequate contraception",
                        "criterion": "use of adequate contraception",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Failure to give informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Failure to give informed consent.",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Failure to give informed consent.",
                    "criterion": "informed consent",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Hemoglobin ≥ 90 g/L",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 90 g/L",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Neutrophils ≥ 1.5 x 109/L",
                "criterions": [
                    {
                        "exact_snippets": "Neutrophils ≥ 1.5 x 109/L",
                        "criterion": "neutrophils",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Platelets ≥ 100 x 109/L",
                "criterions": [
                    {
                        "exact_snippets": "Platelets ≥ 100 x 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Adequate renal function, as indicated by serum creatinine ≤1.5 times the upper limit of normal and/or Creatinine Clearance calculated as >50% lower normal limit, or estimated as ≥ 50 ml/min (Appendix C).",
                "criterions": [
                    {
                        "exact_snippets": "Adequate renal function, as indicated by serum creatinine ≤1.5 times the upper limit of normal",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine Clearance calculated as >50% lower normal limit",
                        "criterion": "Creatinine Clearance",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "% lower normal limit"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine Clearance ... estimated as ≥ 50 ml/min",
                        "criterion": "Creatinine Clearance",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Adequate renal function, as indicated by serum creatinine \u00141.5 times the upper limit of normal",
                                "criterion": "serum creatinine",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "times the upper limit of normal"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Creatinine Clearance calculated as >50% lower normal limit",
                                "criterion": "Creatinine Clearance",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 50,
                                        "unit": "% lower normal limit"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Creatinine Clearance ... estimated as \u001e 50 ml/min",
                        "criterion": "Creatinine Clearance",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* bilirubin ≤ 1.5 times upper normal limit;",
                "criterions": [
                    {
                        "exact_snippets": "bilirubin ≤ 1.5 times upper normal limit",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper normal limit"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "bilirubin \u0010.5 times upper normal limit",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper normal limit"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Left ventricular ejection fraction (LVEF) ≥50% as measured by either multigated acquisition (MUGA) scan or echocardiogram (ECHO).",
                "criterions": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction (LVEF) ≥50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Left ventricular ejection fraction (LVEF) 50%",
                                "criterion": "left ventricular ejection fraction (LVEF)",
                                "requirement": {
                                    "requirement_type": "measurement",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Left ventricular ejection fraction (LVEF) 50%",
                                        "criterion": "measurement method",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "multigated acquisition (MUGA) scan"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Left ventricular ejection fraction (LVEF) 50%",
                                        "criterion": "measurement method",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": "echocardiogram (ECHO)"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                "criterions": [
                    {
                        "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                        "criterion": "condition",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "medical",
                                "social",
                                "psychological",
                                "geographical"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                        "criterion": "condition",
                        "requirement": {
                            "requirement_type": "impact",
                            "expected_value": "prevent adequate follow-up"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "medical"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "impact",
                                    "expected_value": "prevent adequate follow-up"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "social"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "impact",
                                    "expected_value": "prevent adequate follow-up"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "psychological"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "impact",
                                    "expected_value": "prevent adequate follow-up"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "geographical"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Any condition (medical, social, psychological, geographical) that would prevent adequate follow-up.",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "impact",
                                    "expected_value": "prevent adequate follow-up"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}