{
    "info": {
        "nct_id": "NCT00660582",
        "official_title": "FLOX + Cetuximab (Erbitux®): First Line Treatment for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor, A Phase II Study",
        "inclusion_criteria": "Histology and staging disease:\n\n* Histological proven adenocarcinoma of the colon or rectum\n* At least one measurable metastatic lesion according to RECIST criteria\n* If only one metastatic lesion, histology is mandatory\n\nMutation level:\n\n* Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR\n\nGeneral conditions:\n\n* Age >18 and < 75 years\n* WHO performance status ≤ 2; life expectancy of more than 3 months\n* Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L)\n* Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases\n* Written informed consent prior to randomisation must be obtained and documented according to the local regulatory requirements\n\nOther:\n\n* Fertile patients must use adequate contraceptives\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "Prior therapy:\n\n* Prior chemotherapy for advanced/metastatic disease\n* Adjuvant chemotherapy must have ended > 6 months before inclusion\n* Prior treatment with Eloxatin\n* Prior treatment with Erbitux or other treatment to EGFR\n\nPrior or current history:\n\n* Current indication for resection with a curative intent\n* Evidence of CNS metastasis\n* Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis\n* Current history of chronic diarrhea\n* Peripheral neuropathy\n* Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies)\n* Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix\n\nConcomitant treatments:\n\n* Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation\n* Concurrent treatment with any other anti-cancer therapy\n\nOther:\n\n* Pregnant or breast feeding women",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Histology and staging disease:",
                "criterions": [
                    {
                        "exact_snippets": "Histology",
                        "criterion": "histology",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    },
                    {
                        "exact_snippets": "staging disease",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histology",
                        "criterion": "histology",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    },
                    {
                        "exact_snippets": "staging disease",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least one measurable metastatic lesion according to RECIST criteria",
                "criterions": [
                    {
                        "exact_snippets": "At least one measurable metastatic lesion according to RECIST criteria",
                        "criterion": "measurable metastatic lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable metastatic lesion according to RECIST criteria",
                        "criterion": "measurable metastatic lesion",
                        "requirement": {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST criteria"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least one measurable metastatic lesion according to RECIST criteria",
                        "criterion": "measurable metastatic lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable metastatic lesion according to RECIST criteria",
                        "criterion": "measurable metastatic lesion",
                        "requirement": {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST criteria"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* If only one metastatic lesion, histology is mandatory",
                "criterions": [
                    {
                        "exact_snippets": "If only one metastatic lesion, histology is mandatory",
                        "criterion": "metastatic lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "If only one metastatic lesion, histology is mandatory",
                        "criterion": "histology",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "If only one metastatic lesion, histology is mandatory",
                    "criterion": "metastatic lesion",
                    "requirement": {
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": "=",
                            "value": 1,
                            "unit": "N/A"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "If only one metastatic lesion, histology is mandatory",
                    "criterion": "histology",
                    "requirement": {
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "Mutation level:",
                "criterions": [
                    {
                        "exact_snippets": "Mutation level:",
                        "criterion": "mutation level",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Mutation level:",
                        "criterion": "mutation level",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR",
                "criterions": [
                    {
                        "exact_snippets": "Tumor tissue (primary or metastasis)",
                        "criterion": "tumor tissue",
                        "requirement": {
                            "requirement_type": "typological classification",
                            "expected_value": "K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Tumor tissue (primary or metastasis)",
                        "criterion": "tumor tissue",
                        "requirement": {
                            "requirement_type": "typological classification",
                            "expected_value": "K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age >18 and < 75 years",
                "criterions": [
                    {
                        "exact_snippets": "Age >18 and < 75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age >18 and < 75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L)",
                "criterions": [
                    {
                        "exact_snippets": "Adequate haematological function: (Hb ≥ 6.2 μmol/d",
                        "criterion": "haemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6.2,
                                "unit": "μmol/d"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate haematological function: ... ANC ≥ 1.5 x 109/L",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 109/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate haematological function: ... platelets ≥ 100 x 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate haematological function: (Hb ≥ 6.2 μmol/d",
                        "criterion": "haemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6.2,
                                "unit": "μmol/d"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate haematological function: ... ANC ≥ 1.5 x 109/L",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 109/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate haematological function: ... platelets ≥ 100 x 109/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 109/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Written informed consent prior to randomisation must be obtained and documented according to the local regulatory requirements",
                "criterions": [
                    {
                        "exact_snippets": "Written informed consent ... must be obtained and documented",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "according to the local regulatory requirements",
                        "criterion": "local regulatory requirements",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Written informed consent ... must be obtained and documented",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "according to the local regulatory requirements",
                        "criterion": "local regulatory requirements",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Fertile patients must use adequate contraceptives",
                "criterions": [
                    {
                        "exact_snippets": "Fertile patients",
                        "criterion": "fertility",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must use adequate contraceptives",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "must use adequate contraceptives",
                    "criterion": "contraceptive use",
                    "requirement": {
                        "requirement_type": "adequacy",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "General conditions:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Other:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "Prior therapy:",
                "criterions": [
                    {
                        "exact_snippets": "Prior therapy",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior therapy",
                    "criterion": "prior therapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Prior chemotherapy for advanced/metastatic disease",
                "criterions": [
                    {
                        "exact_snippets": "Prior chemotherapy for advanced/metastatic disease",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "advanced/metastatic disease"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior chemotherapy for advanced/metastatic disease",
                    "criterion": "prior chemotherapy",
                    "requirement": {
                        "requirement_type": "condition",
                        "expected_value": "advanced/metastatic disease"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Adjuvant chemotherapy must have ended > 6 months before inclusion",
                "criterions": [
                    {
                        "exact_snippets": "Adjuvant chemotherapy must have ended > 6 months before inclusion",
                        "criterion": "adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adjuvant chemotherapy must have ended > 6 months before inclusion",
                        "criterion": "adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with Eloxatin",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with Eloxatin",
                        "criterion": "Eloxatin treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior treatment with Eloxatin",
                    "criterion": "Eloxatin treatment",
                    "requirement": {
                        "requirement_type": "prior treatment",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with Erbitux or other treatment to EGFR",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with Erbitux",
                        "criterion": "prior treatment with Erbitux",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other treatment to EGFR",
                        "criterion": "prior treatment to EGFR",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Prior treatment with Erbitux",
                        "criterion": "prior treatment with Erbitux",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other treatment to EGFR",
                        "criterion": "prior treatment to EGFR",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Prior or current history:",
                "criterions": [
                    {
                        "exact_snippets": "Prior or current history",
                        "criterion": "medical history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior or current history",
                        "criterion": "medical history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Current indication for resection with a curative intent",
                "criterions": [
                    {
                        "exact_snippets": "Current indication for resection with a curative intent",
                        "criterion": "indication for resection",
                        "requirement": {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Current indication for resection with a curative intent",
                        "criterion": "indication for resection",
                        "requirement": {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evidence of CNS metastasis",
                "criterions": [
                    {
                        "exact_snippets": "Evidence of CNS metastasis",
                        "criterion": "CNS metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Evidence of CNS metastasis",
                    "criterion": "CNS metastasis",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis",
                "criterions": [
                    {
                        "exact_snippets": "Current infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unresolved bowel obstruction or subobstruction",
                        "criterion": "bowel obstruction or subobstruction",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled Crohn's disease",
                        "criterion": "Crohn's disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled ... ulcerative colitis",
                        "criterion": "ulcerative colitis",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Current infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unresolved bowel obstruction or subobstruction",
                        "criterion": "bowel obstruction or subobstruction",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled Crohn's disease",
                        "criterion": "Crohn's disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled ... ulcerative colitis",
                        "criterion": "ulcerative colitis",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Current history of chronic diarrhea",
                "criterions": [
                    {
                        "exact_snippets": "Current history of chronic diarrhea",
                        "criterion": "chronic diarrhea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Current history of chronic diarrhea",
                    "criterion": "chronic diarrhea",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Peripheral neuropathy",
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                    {
                        "exact_snippets": "Peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies)",
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                    {
                        "exact_snippets": "serious illness or medical conditions",
                        "criterion": "serious illness or medical conditions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "contraindication to 5 FU",
                        "criterion": "contraindication to 5 FU",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "angor",
                        "criterion": "angor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction within 6 months",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "contraindications to monoclonal antibodies",
                        "criterion": "contraindications to monoclonal antibodies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "serious illness or medical conditions",
                                                "criterion": "serious illness or medical conditions",
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                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "exact_snippets": "contraindication to 5 FU",
                                                "criterion": "contraindication to 5 FU",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "angor",
                                        "criterion": "angor",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
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                                    }
                                ]
                            },
                            {
                                "exact_snippets": "myocardial infarction within 6 months",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time since occurrence",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "contraindications to monoclonal antibodies",
                        "criterion": "contraindications to monoclonal antibodies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix",
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                    {
                        "exact_snippets": "Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years",
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                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "curatively treated non melanoma skin cancer",
                        "criterion": "non melanoma skin cancer",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    },
                    {
                        "exact_snippets": "in situ carcinoma of the cervix",
                        "criterion": "carcinoma of the cervix",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "in situ"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years",
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                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "curatively treated non melanoma skin cancer",
                                    "criterion": "non melanoma skin cancer",
                                    "requirement": {
                                        "requirement_type": "treatment status",
                                        "expected_value": "curatively treated"
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "in situ carcinoma of the cervix",
                                    "criterion": "carcinoma of the cervix",
                                    "requirement": {
                                        "requirement_type": "stage",
                                        "expected_value": "in situ"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Concomitant treatments:",
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                    {
                        "exact_snippets": "Concomitant treatments",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Concomitant treatments",
                    "criterion": "concomitant treatments",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation",
                "criterions": [
                    {
                        "exact_snippets": "Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation",
                        "criterion": "administration of experimental drug",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "concomitant or within 4 weeks before randomisation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation",
                    "criterion": "administration of experimental drug",
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                        "requirement_type": "time frame",
                        "expected_value": "concomitant or within 4 weeks before randomisation"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent treatment with any other anti-cancer therapy",
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                    {
                        "exact_snippets": "Concurrent treatment with any other anti-cancer therapy",
                        "criterion": "concurrent anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    "exact_snippets": "Concurrent treatment with any other anti-cancer therapy",
                    "criterion": "concurrent anti-cancer therapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or breast feeding women",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
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                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Other:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Histological proven adenocarcinoma of the colon or rectum",
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                    {
                        "exact_snippets": "Histological proven adenocarcinoma",
                        "criterion": "adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histological"
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                    },
                    {
                        "exact_snippets": "adenocarcinoma of the colon or rectum",
                        "criterion": "cancer location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "colon",
                                "rectum"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histological proven adenocarcinoma",
                        "criterion": "adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histological"
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "adenocarcinoma of the colon or rectum",
                                "criterion": "cancer location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "colon"
                                }
                            },
                            {
                                "exact_snippets": "adenocarcinoma of the colon or rectum",
                                "criterion": "cancer location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "rectum"
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                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "adenocarcinoma of the colon or rectum",
                                "criterion": "cancer location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "colon"
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                            },
                            {
                                "exact_snippets": "adenocarcinoma of the colon or rectum",
                                "criterion": "cancer location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "rectum"
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                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
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                    {
                        "exact_snippets": "WHO performance status ≤ 2",
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                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
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                        }
                    },
                    {
                        "exact_snippets": "life expectancy of more than 3 months",
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                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
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                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "WHO performance status \u0010 2",
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                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "life expectancy of more than 3 months",
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                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases",
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                    {
                        "exact_snippets": "Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit",
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                            "requirement_type": "level",
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                                "value": 1.5,
                                "unit": "upper normal limit"
                            }
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                    {
                        "exact_snippets": "Adequate renal and hepatic functions: ... creatinine ≤ 1.25 × upper normal limit",
                        "criterion": "creatinine",
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                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.25,
                                "unit": "upper normal limit"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate renal and hepatic functions: ... ALAT ≤ 3 x upper normal limits",
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                            "requirement_type": "level",
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                                "operator": "<=",
                                "value": 3,
                                "unit": "upper normal limits"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate renal and hepatic functions: ... ALAT ... ≤ 5 x upper normal limits in case of liver metastases",
                        "criterion": "ALAT in case of liver metastases",
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                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "upper normal limits"
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                ]
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            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate renal and hepatic functions: total bilirubin \u0010.5 upper normal limit",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "upper normal limit"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Adequate renal and hepatic functions: ... creatinine \u00121.25 \r upper normal limit",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.25,
                                "unit": "upper normal limit"
                            }
                        }
                    },
                    {
                        "condition": {
                            "exact_snippets": "Adequate renal and hepatic functions: ... ALAT ... \u0005 x upper normal limits in case of liver metastases",
                            "criterion": "ALAT in case of liver metastases",
                            "requirement": {
                                "requirement_type": "level",
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                                    "operator": "<=",
                                    "value": 5,
                                    "unit": "upper normal limits"
                                }
                            }
                        },
                        "then_criteria": null,
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                            "exact_snippets": "Adequate renal and hepatic functions: ... ALAT \u0003 x upper normal limits",
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                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 3,
                                    "unit": "upper normal limits"
                                }
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}