{
    "info": {
        "nct_id": "NCT01951482",
        "official_title": "Multicenter Phase II Study of Pemetrexed/Cisplatin With or Without Bevacizumab in Patients With Brain Metastases From Non Squamous Non-small Cell Lung Cancer Harboring EGFR Wild Type",
        "inclusion_criteria": "1. Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brain metastases by pathologic histology or cytology\n2. Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases\n3. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI\n4. Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).\n5. Patients should be contraceptive during the period of the trial\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.\n2. History of haemoptysis\n3. Evidence of tumour invading major blood vessels on imaging.\n4. Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.\n5. Previous radiotherapy.\n6. Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6 months prior to study start or history of serious bleeding complications.\n7. Major surgical procedures within 4 weeks prior to study entry.\n8. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.\n9. Non-healing wound, active peptic ulcer or bone fracture.\n10. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brain metastases by pathologic histology or cytology",
                "criterions": [
                    {
                        "exact_snippets": "confirmed stage IV non squamous NSCLC",
                        "criterion": "stage of non squamous NSCLC",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    },
                    {
                        "exact_snippets": "EGFR wild type",
                        "criterion": "EGFR status",
                        "requirement": {
                            "requirement_type": "mutation type",
                            "expected_value": "wild type"
                        }
                    },
                    {
                        "exact_snippets": "brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "confirmed stage IV non squamous NSCLC",
                                "criterion": "stage of non squamous NSCLC",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "IV"
                                }
                            },
                            {
                                "exact_snippets": "EGFR wild type",
                                "criterion": "EGFR status",
                                "requirement": {
                                    "requirement_type": "mutation type",
                                    "expected_value": "wild type"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases",
                "criterions": [
                    {
                        "exact_snippets": "Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases",
                        "criterion": "therapy after diagnosed brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases",
                        "criterion": "chemotherapy after diagnosed brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases",
                        "criterion": "WBRT after diagnosed brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases",
                        "criterion": "Bevacizumab after diagnosed brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases",
                            "criterion": "therapy after diagnosed brain metastases",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases",
                            "criterion": "chemotherapy after diagnosed brain metastases",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases",
                            "criterion": "WBRT after diagnosed brain metastases",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases",
                            "criterion": "Bevacizumab after diagnosed brain metastases",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI",
                "criterions": [
                    {
                        "exact_snippets": "Appraisable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "appraisability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "the presence of at least three lesions",
                        "criterion": "lesions",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "lesions"
                            }
                        }
                    },
                    {
                        "exact_snippets": "longest diameter <10 mm by brain MRI",
                        "criterion": "lesion size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Appraisable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "appraisability",
                            "expected_value": true
                        }
                    },
                    {
                        "condition": {
                            "exact_snippets": "longest diameter <10 mm by brain MRI",
                            "criterion": "lesion size",
                            "requirement": {
                                "requirement_type": "size",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 10,
                                    "unit": "mm"
                                }
                            }
                        },
                        "then_criteria": {
                            "exact_snippets": "the presence of at least three lesions",
                            "criterion": "lesions",
                            "requirement": {
                                "requirement_type": "quantity",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 3,
                                    "unit": "lesions"
                                }
                            }
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).",
                "criterions": [
                    {
                        "exact_snippets": "Adult patients (≥ 18 years and ≤75 years)",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "ECOG Performance Status 0 or 1",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Life expectancy of at least 12 weeks",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Haemoglobin ³ 10.0 g/dl",
                        "criterion": "haemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10.0,
                                "unit": "g/dl"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ³1.5 x 109/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets ³ 100 x 109/L",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Total bilirubin £ 1.5 x upper limit of normal (ULN)",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT and AST < 2.5 x ULN in the absence of liver metastases",
                        "criterion": "ALT and AST without liver metastases",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT and AST ... < 5 x ULN in case of liver metastases",
                        "criterion": "ALT and AST with liver metastases",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula)",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Adult patients (≥ 18 years and ≤75 years)",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 18,
                                                "unit": "years"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 75,
                                                "unit": "years"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "ECOG Performance Status 0 or 1",
                                "criterion": "ECOG Performance Status",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": [
                                        "0",
                                        "1"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Life expectancy of at least 12 weeks",
                                "criterion": "life expectancy",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 12,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Haemoglobin ³ 10.0 g/dl",
                                "criterion": "haemoglobin",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 10.0,
                                        "unit": "g/dl"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Absolute neutrophil count (ANC) ³1.5 x 109/L",
                                "criterion": "absolute neutrophil count (ANC)",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "x 10^9/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "platelets ³ 100 x 109/L",
                                "criterion": "platelets",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 100,
                                        "unit": "x 10^9/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Total bilirubin £ 1.5 x upper limit of normal (ULN)",
                                "criterion": "total bilirubin",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "x ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula)",
                                "criterion": "creatinine clearance",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "ml/min"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "ALT and AST < 2.5 x ULN in the absence of liver metastases",
                                "criterion": "ALT and AST without liver metastases",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "ALT and AST ... < 5 x ULN in case of liver metastases",
                                "criterion": "ALT and AST with liver metastases",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Patients should be contraceptive during the period of the trial",
                "criterions": [
                    {
                        "exact_snippets": "Patients should be contraceptive during the period of the trial",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients should be contraceptive during the period of the trial",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.",
                "criterions": [
                    {
                        "exact_snippets": "Mixed, non-small cell and small cell tumours",
                        "criterion": "tumour type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "mixed",
                                "non-small cell",
                                "small cell"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "mixed adenosquamous carcinomas with a predominant squamous component",
                        "criterion": "carcinoma type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "mixed adenosquamous"
                        }
                    },
                    {
                        "exact_snippets": "mixed adenosquamous carcinomas with a predominant squamous component",
                        "criterion": "carcinoma type",
                        "requirement": {
                            "requirement_type": "component",
                            "expected_value": "predominant squamous"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Mixed, non-small cell and small cell tumours",
                                "criterion": "tumour type",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": [
                                        "mixed",
                                        "non-small cell",
                                        "small cell"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "mixed adenosquamous carcinomas with a predominant squamous component",
                                "criterion": "carcinoma type",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "mixed adenosquamous"
                                }
                            },
                            {
                                "exact_snippets": "mixed adenosquamous carcinomas with a predominant squamous component",
                                "criterion": "carcinoma type",
                                "requirement": {
                                    "requirement_type": "component",
                                    "expected_value": "predominant squamous"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. History of haemoptysis",
                "criterions": [
                    {
                        "exact_snippets": "History of haemoptysis",
                        "criterion": "haemoptysis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "History of haemoptysis",
                    "criterion": "haemoptysis",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Evidence of tumour invading major blood vessels on imaging.",
                "criterions": [
                    {
                        "exact_snippets": "tumour invading major blood vessels on imaging",
                        "criterion": "tumour invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "tumour invading major blood vessels on imaging",
                        "criterion": "tumour invasion",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "major blood vessels"
                        }
                    },
                    {
                        "exact_snippets": "tumour invading major blood vessels on imaging",
                        "criterion": "tumour invasion",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": "imaging"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "tumour invading major blood vessels on imaging",
                                "criterion": "tumour invasion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "tumour invading major blood vessels on imaging",
                                "criterion": "tumour invasion",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "major blood vessels"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "tumour invading major blood vessels on imaging",
                        "criterion": "tumour invasion",
                        "requirement": {
                            "requirement_type": "detection method",
                            "expected_value": "imaging"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.",
                "criterions": [
                    {
                        "exact_snippets": "Patient was received irradiation of brain",
                        "criterion": "brain irradiation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid",
                        "criterion": "meningeal metastases",
                        "requirement": {
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}