{
    "info": {
        "nct_id": "NCT01978873",
        "official_title": "Randomized Phase III Trial Comparing Cabazitaxel Combination Hormone Therapy to Hormone Therapy Alone in Metastatic Prostate Cancer or High Risk Disease",
        "inclusion_criteria": "* Histological or cytological confirmed prostate adenocarcinoma Metastatic PC (Prostate cancer) with measurable or evaluable disease or High risk PC (PSA > 100) or Node positive disease (N+)\n* No prior treatment for prostate cancer (including bisfosfonate)\n* Age above 18 years\n* ECOG 0- 2\n* Estimated survival > 3 months\n* WBC 2000 / mm 3, neutrophils ≥1500 / mm 3, platelets 100,000 / mm 3\n* Satisfactory liver function: bilirubin, transaminases ≤ 1.5 times the upper limit of normal.\n* Satisfactory renal function. Serum creatinine <1.5 x ULN (150 mmol/l). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance >60 mL/min are accepted in the study. https://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr\n* Patient information and signature of informed consent\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)\n* Severe peripheral neuropathy\n* Active infection or other serious underlying pathology that could prevent patients from receiving treatment\n* History of cancer within 5 years before inclusion in the study other than basal cell or squamous cell skin cancer adequately treated\n* Brain metastases, uncontrolled symptomatic or asymptomatic\n* Patient participating in another clinical trial protocol with a molecule during this experimental study or treated four weeks prior to randomization.\n* Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)\n* Systemic treatment with high dose steroids\n* Any severe acute or chronic medical condition which would impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.\n* History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Satisfactory renal function. Serum creatinine <1.5 x ULN (150 mmol/l). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance >60 mL/min are accepted in the study. https://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr",
                "criterions": [
                    {
                        "exact_snippets": "Satisfactory renal function.",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "satisfaction",
                            "expected_value": "satisfactory"
                        }
                    },
                    {
                        "exact_snippets": "Serum creatinine <1.5 x ULN (150 mmol/l).",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance >60 mL/min are accepted",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Satisfactory renal function.",
                                "criterion": "renal function",
                                "requirement": {
                                    "requirement_type": "satisfaction",
                                    "expected_value": "satisfactory"
                                }
                            },
                            {
                                "exact_snippets": "Serum creatinine <1.5 x ULN (150 mmol/l).",
                                "criterion": "serum creatinine",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 1.5,
                                        "unit": "x ULN"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Serum creatinine <1.5 x ULN (150 mmol/l).",
                                    "criterion": "serum creatinine",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 1.0,
                                            "unit": "x ULN"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "Serum creatinine <1.5 x ULN (150 mmol/l).",
                                    "criterion": "serum creatinine",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1.5,
                                            "unit": "x ULN"
                                        }
                                    }
                                }
                            ]
                        },
                        "then_criteria": {
                            "exact_snippets": "If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance >60 mL/min are accepted",
                            "criterion": "creatinine clearance",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "operator": ">",
                                    "value": 60,
                                    "unit": "mL/min"
                                }
                            }
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient information and signature of informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Patient information",
                        "criterion": "patient information",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "signature of informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patient information",
                        "criterion": "patient information",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "signature of informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signature",
                            "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 be MALE",
                "criterions": [
                    {
                        "exact_snippets": "MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)",
                "criterions": [
                    {
                        "exact_snippets": "Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe symptomatic coronary artery disease"
                        }
                    },
                    {
                        "exact_snippets": "Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "congenital heart failure"
                        }
                    },
                    {
                        "exact_snippets": "Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "NYHA class",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe symptomatic coronary artery disease"
                                }
                            },
                            {
                                "exact_snippets": "Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "congenital heart failure"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "NYHA class",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Severe peripheral neuropathy",
                "criterions": [
                    {
                        "exact_snippets": "Severe peripheral neuropathy",
                        "criterion": "peripheral neuropathy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Severe peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": "severe"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active infection or other serious underlying pathology that could prevent patients from receiving treatment",
                "criterions": [
                    {
                        "exact_snippets": "Active infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "serious underlying pathology",
                        "criterion": "underlying pathology",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Active infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "serious underlying pathology",
                        "criterion": "underlying pathology",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of cancer within 5 years before inclusion in the study other than basal cell or squamous cell skin cancer adequately treated",
                "criterions": [
                    {
                        "exact_snippets": "History of cancer within 5 years before inclusion in the study",
                        "criterion": "history of cancer",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "other than basal cell or squamous cell skin cancer",
                        "criterion": "type of cancer",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "basal cell skin cancer",
                                "squamous cell skin cancer"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "adequately treated",
                        "criterion": "treatment status",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": "adequately treated"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of cancer within 5 years before inclusion in the study",
                                "criterion": "history of cancer",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 5,
                                                "unit": "years"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "other than basal cell or squamous cell skin cancer",
                                    "criterion": "type of cancer",
                                    "requirement": {
                                        "requirement_type": "exclusion",
                                        "expected_value": [
                                            "basal cell skin cancer",
                                            "squamous cell skin cancer"
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "adequately treated",
                        "criterion": "treatment status",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": "adequately treated"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5",
                        "criterion": "treatment with potent inhibitors or inducers of cytochrome P450 3A4/5",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5",
                    "criterion": "treatment with potent inhibitors or inducers of cytochrome P450 3A4/5",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "a one week wash-out period is necessary for patients who are already on these treatments",
                    "criterion": "wash-out period",
                    "requirement": {
                        "requirement_type": "duration",
                        "expected_value": {
                            "operator": ">=",
                            "value": 1,
                            "unit": "week"
                        }
                    }
                },
                "else_criteria": {
                    "exact_snippets": "Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5",
                    "criterion": "treatment with potent inhibitors or inducers of cytochrome P450 3A4/5",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Systemic treatment with high dose steroids",
                "criterions": [
                    {
                        "exact_snippets": "Systemic treatment with high dose steroids",
                        "criterion": "systemic treatment",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "high dose steroids"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Systemic treatment with high dose steroids",
                    "criterion": "systemic treatment",
                    "requirement": {
                        "requirement_type": "medication",
                        "expected_value": "high dose steroids"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any severe acute or chronic medical condition which would impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.",
                "criterions": [
                    {
                        "exact_snippets": "Any severe acute or chronic medical condition",
                        "criterion": "medical condition",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Any severe acute or chronic medical condition",
                        "criterion": "medical condition",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "patient unable to comply with the study procedures",
                        "criterion": "compliance with study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Any severe acute or chronic medical condition",
                                        "criterion": "medical condition",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": "severe"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Any severe acute or chronic medical condition",
                                        "criterion": "medical condition",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": [
                                                "acute",
                                                "chronic"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Any severe acute or chronic medical condition",
                                "criterion": "medical condition",
                                "requirement": {
                                    "requirement_type": "ability to participate",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "patient unable to comply with the study procedures",
                        "criterion": "compliance with study procedures",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs",
                "criterions": [
                    {
                        "exact_snippets": "History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs",
                        "criterion": "hypersensitivity reaction to polysorbate 80 containing drugs",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs",
                        "criterion": "hypersensitivity reaction to polysorbate 80 containing drugs",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Histological or cytological confirmed prostate adenocarcinoma Metastatic PC (Prostate cancer) with measurable or evaluable disease or High risk PC (PSA > 100) or Node positive disease (N+)",
                "criterions": [
                    {
                        "exact_snippets": "Histological or cytological confirmed prostate adenocarcinoma",
                        "criterion": "prostate adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Metastatic PC (Prostate cancer)",
                        "criterion": "metastatic prostate cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "measurable or evaluable disease",
                        "criterion": "disease measurability/evaluability",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "High risk PC (PSA > 100)",
                        "criterion": "prostate cancer risk",
                        "requirement": {
                            "requirement_type": "PSA level",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": ""
                            }
                        }
                    },
                    {
                        "exact_snippets": "Node positive disease (N+)",
                        "criterion": "node positive disease",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "N+"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* No prior treatment for prostate cancer (including bisfosfonate)",
                "criterions": [
                    {
                        "exact_snippets": "No prior treatment for prostate cancer",
                        "criterion": "prior treatment for prostate cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "(including bisfosfonate)",
                        "criterion": "prior bisfosfonate treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Age above 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age above 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* ECOG 0- 2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG 0- 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Estimated survival > 3 months",
                "criterions": [
                    {
                        "exact_snippets": "Estimated survival > 3 months",
                        "criterion": "estimated survival",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* WBC 2000 / mm 3, neutrophils ≥1500 / mm 3, platelets 100,000 / mm 3",
                "criterions": [
                    {
                        "exact_snippets": "WBC 2000 / mm 3",
                        "criterion": "WBC",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "/ mm 3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "neutrophils ≥1500 / mm 3",
                        "criterion": "neutrophils",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "/ mm 3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets 100,000 / mm 3",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/ mm 3"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Satisfactory liver function: bilirubin, transaminases ≤ 1.5 times the upper limit of normal.",
                "criterions": [
                    {
                        "exact_snippets": "Satisfactory liver function: bilirubin, transaminases ≤ 1.5 times the upper limit of normal.",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "satisfactory",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "bilirubin ... ≤ 1.5 times the upper limit of normal.",
                        "criterion": "bilirubin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "transaminases ≤ 1.5 times the upper limit of normal.",
                        "criterion": "transaminases level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "bilirubin ... ≤ 1.5 times the upper limit of normal.",
                                "criterion": "bilirubin level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "times the upper limit of normal"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "transaminases ≤ 1.5 times the upper limit of normal.",
                                "criterion": "transaminases level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "times the upper limit of normal"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Brain metastases, uncontrolled symptomatic or asymptomatic",
                "criterions": [
                    {
                        "exact_snippets": "Brain metastases, uncontrolled symptomatic or asymptomatic",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Brain metastases, uncontrolled symptomatic or asymptomatic",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptom presence",
                            "expected_value": [
                                "symptomatic",
                                "asymptomatic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Brain metastases, uncontrolled symptomatic or asymptomatic",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Brain metastases, uncontrolled symptomatic or asymptomatic",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "symptom presence",
                                    "expected_value": "symptomatic"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Brain metastases, uncontrolled symptomatic or asymptomatic",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Brain metastases, uncontrolled symptomatic or asymptomatic",
                                "criterion": "brain metastases",
                                "requirement": {
                                    "requirement_type": "symptom presence",
                                    "expected_value": "asymptomatic"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patient participating in another clinical trial protocol with a molecule during this experimental study or treated four weeks prior to randomization.",
                "criterions": [
                    {
                        "exact_snippets": "Patient participating in another clinical trial protocol",
                        "criterion": "participation in another clinical trial",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "treated four weeks prior to randomization",
                        "criterion": "treatment prior to randomization",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Patient participating in another clinical trial protocol",
                                "criterion": "participation in another clinical trial",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "treated four weeks prior to randomization",
                                "criterion": "treatment prior to randomization",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}