{
    "info": {
        "nct_id": "NCT00810394",
        "official_title": "Single Agent Sorafenib in Advanced Solid Tumors: Phase II Evaluation of Dose Re-Escalation Following a Dose Reduction (IST000375)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\n* Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective or solid tumor for which sorafenib is considered acceptable therapy\n* Age > 18 years old\n* Performance Status 0 - 2\n* Measurable or non-measurable disease.\n* Adequate bone marrow, liver and renal function\n* Any number of prior chemotherapy regimens are allowed.\n* Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy.\n* Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment\n* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.\n* Ability to understand and the willingness to sign a written informed consent.\n* International normalized ratio < 1.5 or a Prothrombin Time/Partial thromboplastin time within normal limits.\n\nExclusion Criteria\n\n* Prior therapy with sorafenib or sunitinib.\n* Cardiac disease: Congestive heart failure > class II New York Heart Association.\n* Symptomatic or uncontrolled brain metastasis.\n* No component of squamous carcinoma can be present in any patient with non-small cell lung cancer\n* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\n* Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.\n* Known HIV infection or chronic Hepatitis B or C.\n* Active clinically serious infection > CTCAE Grade 2.\n* Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.\n* Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.\n* Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.\n* Serious non-healing wound, ulcer, or bone fracture.\n* Evidence or history of bleeding diathesis or coagulopathy\n* Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.\n* Use of St. John's Wort or rifampin\n* Known or suspected allergy to sorafenib or any agent given in the course of this trial.\n* Any condition that impairs patient's ability to swallow whole pills.\n* Any significant malabsorption problem.\n* Therapy with bevacizumab < 3 months prior to first dose of study drug."
    },
    "inclusion_lines": [
        {
            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "* Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective or solid tumor for which sorafenib is considered acceptable therapy",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or cytologically confirmed metastatic or unresectable solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Histologically or cytologically confirmed metastatic or unresectable solid tumor",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "metastatic",
                                "unresectable"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "solid tumor for which standard curative or palliative measures do not exist or are no longer effective",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "treatment options",
                            "expected_value": "standard curative or palliative measures do not exist or are no longer effective"
                        }
                    },
                    {
                        "exact_snippets": "solid tumor for which sorafenib is considered acceptable therapy",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "treatment options",
                            "expected_value": "sorafenib is considered acceptable therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Histologically or cytologically confirmed metastatic or unresectable solid tumor",
                                        "criterion": "solid tumor",
                                        "requirement": {
                                            "requirement_type": "confirmation",
                                            "expected_value": [
                                                "histologically",
                                                "cytologically"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Histologically or cytologically confirmed metastatic or unresectable solid tumor",
                                        "criterion": "solid tumor",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": [
                                                "metastatic",
                                                "unresectable"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "solid tumor for which standard curative or palliative measures do not exist or are no longer effective",
                                "criterion": "solid tumor",
                                "requirement": {
                                    "requirement_type": "treatment options",
                                    "expected_value": "standard curative or palliative measures do not exist or are no longer effective"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "solid tumor for which sorafenib is considered acceptable therapy",
                        "criterion": "solid tumor",
                        "requirement": {
                            "requirement_type": "treatment options",
                            "expected_value": "sorafenib is considered acceptable therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age > 18 years old",
                "criterions": [
                    {
                        "exact_snippets": "Age > 18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age > 18 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Performance Status 0 - 2",
                "criterions": [
                    {
                        "exact_snippets": "Performance Status 0 - 2",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Performance Status 0 - 2",
                        "criterion": "performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate bone marrow, liver and renal function",
                "criterions": [
                    {
                        "exact_snippets": "Adequate bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate bone marrow",
                        "criterion": "bone marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... liver",
                        "criterion": "liver function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal function",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any number of prior chemotherapy regimens are allowed.",
                "criterions": [
                    {
                        "exact_snippets": "Any number of prior chemotherapy regimens are allowed.",
                        "criterion": "prior chemotherapy regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": "any number"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Any number of prior chemotherapy regimens are allowed.",
                        "criterion": "prior chemotherapy regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": "any number"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol",
                        "criterion": "prior chemotherapy, immunotherapy or targeted therapy",
                        "requirement": {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "all side effects resolved to grade 1 or less",
                        "criterion": "side effects",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Any prior radiation must have been completed at least 2 weeks prior to start of therapy",
                        "criterion": "prior radiation",
                        "requirement": {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol",
                                        "criterion": "prior chemotherapy, immunotherapy or targeted therapy",
                                        "requirement": {
                                            "requirement_type": "completion time",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Any prior radiation must have been completed at least 2 weeks prior to start of therapy",
                                        "criterion": "prior radiation",
                                        "requirement": {
                                            "requirement_type": "completion time",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "all side effects resolved to grade 1 or less",
                                "criterion": "side effects",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "grade"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment",
                "criterions": [
                    {
                        "exact_snippets": "Women of childbearing potential",
                        "criterion": "childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must have a negative pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "performed within 7 days prior to the start of treatment",
                        "criterion": "pregnancy test timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the start of treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "must have a negative pregnancy test",
                            "criterion": "pregnancy test",
                            "requirement": {
                                "requirement_type": "result",
                                "expected_value": "negative"
                            }
                        },
                        {
                            "exact_snippets": "performed within 7 days prior to the start of treatment",
                            "criterion": "pregnancy test timing",
                            "requirement": {
                                "requirement_type": "timing",
                                "expected_value": "within 7 days prior to the start of treatment"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.",
                "criterions": [
                    {
                        "exact_snippets": "Women of childbearing potential",
                        "criterion": "women of childbearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "men must agree to use adequate contraception",
                        "criterion": "contraception use by men",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "prior to study entry and for the duration of study participation"
                        }
                    },
                    {
                        "exact_snippets": "Men should use adequate birth control for at least three months after the last administration of sorafenib",
                        "criterion": "contraception use by men after sorafenib",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "at least three months after the last administration of sorafenib"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Women of childbearing potential",
                                "criterion": "women of childbearing potential",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "prior to study entry and for the duration of study participation"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "men must agree to use adequate contraception",
                                "criterion": "contraception use by men",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Men should use adequate birth control for at least three months after the last administration of sorafenib",
                                "criterion": "contraception use by men after sorafenib",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "at least three months after the last administration of sorafenib"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ability to understand and the willingness to sign a written informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* International normalized ratio < 1.5 or a Prothrombin Time/Partial thromboplastin time within normal limits.",
                "criterions": [
                    {
                        "exact_snippets": "International normalized ratio < 1.5",
                        "criterion": "International normalized ratio",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prothrombin Time/Partial thromboplastin time within normal limits",
                        "criterion": "Prothrombin Time/Partial thromboplastin time",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "within normal limits"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "International normalized ratio < 1.5",
                        "criterion": "International normalized ratio",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Prothrombin Time/Partial thromboplastin time within normal limits",
                        "criterion": "Prothrombin Time/Partial thromboplastin time",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "within normal limits"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior therapy with sorafenib or sunitinib.",
                "criterions": [
                    {
                        "exact_snippets": "Prior therapy with sorafenib",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "sorafenib"
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy with ... sunitinib",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "sunitinib"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Prior therapy with sorafenib",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "sorafenib"
                        }
                    },
                    {
                        "exact_snippets": "Prior therapy with ... sunitinib",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "medication",
                            "expected_value": "sunitinib"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Cardiac disease: Congestive heart failure > class II New York Heart Association.",
                "criterions": [
                    {
                        "exact_snippets": "Cardiac disease: Congestive heart failure > class II New York Heart Association.",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "class New York Heart Association"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Cardiac disease: Congestive heart failure > class II New York Heart Association.",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "class New York Heart Association"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Symptomatic or uncontrolled brain metastasis.",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic ... brain metastasis.",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled brain metastasis.",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Symptomatic ... brain metastasis.",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled brain metastasis.",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No component of squamous carcinoma can be present in any patient with non-small cell lung cancer",
                "criterions": [
                    {
                        "exact_snippets": "No component of squamous carcinoma can be present",
                        "criterion": "squamous carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "patient with non-small cell lung cancer",
                        "criterion": "non-small cell lung cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No component of squamous carcinoma can be present",
                        "criterion": "squamous carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "patient with non-small cell lung cancer",
                        "criterion": "non-small cell lung cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy",
                        "criterion": "cardiac ventricular arrhythmias",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "requiring anti-arrhythmic therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy",
                        "criterion": "cardiac ventricular arrhythmias",
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                            "requirement_type": "severity",
                            "expected_value": "requiring anti-arrhythmic therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg",
                        "criterion": "systolic blood pressure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled hypertension defined as ... diastolic pressure > 90 mmHg",
                        "criterion": "diastolic pressure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled hypertension ... despite optimal medical management",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg",
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                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 150,
                                        "unit": "mmHg"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled hypertension defined as ... diastolic pressure > 90 mmHg",
                                "criterion": "diastolic pressure",
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                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 90,
                                        "unit": "mmHg"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Uncontrolled hypertension ... despite optimal medical management",
                        "criterion": "hypertension",
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                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active clinically serious infection > CTCAE Grade 2.",
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                    {
                        "exact_snippets": "Active clinically serious infection > CTCAE Grade 2",
                        "criterion": "clinically serious infection",
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                            "requirement_type": "severity",
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                                "operator": ">",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Active clinically serious infection > CTCAE Grade 2",
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                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.",
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                    {
                        "exact_snippets": "Thrombolic or embolic events",
                        "criterion": "thrombolic or embolic events",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "cerebrovascular accident",
                        "criterion": "cerebrovascular accident",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "transient ischemic attacks",
                        "criterion": "transient ischemic attacks",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within the past 6 months",
                        "criterion": "time since event",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Thrombolic or embolic events",
                                        "criterion": "thrombolic or embolic events",
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                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "within the past 6 months",
                                        "criterion": "time since event",
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                                            "requirement_type": "time frame",
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                                                    {
                                                        "operator": "<=",
                                                        "value": 6,
                                                        "unit": "months"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "cerebrovascular accident",
                                        "criterion": "cerebrovascular accident",
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                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "within the past 6 months",
                                        "criterion": "time since event",
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                                            "requirement_type": "time frame",
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                                                    {
                                                        "operator": "<=",
                                                        "value": 6,
                                                        "unit": "months"
                                                    }
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                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "transient ischemic attacks",
                                        "criterion": "transient ischemic attacks",
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                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "within the past 6 months",
                                        "criterion": "time since event",
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                                            "requirement_type": "time frame",
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                                                    {
                                                        "operator": "<=",
                                                        "value": 6,
                                                        "unit": "months"
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                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.",
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                    {
                        "exact_snippets": "Pulmonary hemorrhage/bleeding event > CTCAE Grade 2",
                        "criterion": "pulmonary hemorrhage/bleeding event",
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                            "requirement_type": "severity",
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                                "operator": ">",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks of first dose of study drug",
                        "criterion": "time since pulmonary hemorrhage/bleeding event",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pulmonary hemorrhage/bleeding event > CTCAE Grade 2",
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                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks of first dose of study drug",
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                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.",
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                    {
                        "exact_snippets": "Any other hemorrhage/bleeding event > CTCAE Grade 3",
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                            "requirement_type": "severity",
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                                "operator": ">",
                                "value": 3,
                                "unit": "CTCAE Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks of first dose of study drug",
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                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any other hemorrhage/bleeding event > CTCAE Grade 3",
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                                        "operator": ">",
                                        "value": 3,
                                        "unit": "CTCAE Grade"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "within 4 weeks of first dose of study drug",
                                "criterion": "time since hemorrhage/bleeding event",
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                                    "requirement_type": "time since event",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
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                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serious non-healing wound, ulcer, or bone fracture.",
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                    {
                        "exact_snippets": "Serious non-healing wound",
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                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        }
                    },
                    {
                        "exact_snippets": "Serious non-healing wound",
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                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "ulcer",
                        "criterion": "ulcer",
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                            "requirement_type": "healing status",
                            "expected_value": "non-healing"
                        }
                    },
                    {
                        "exact_snippets": "ulcer",
                        "criterion": "ulcer",
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                            "requirement_type": "severity",
                            "expected_value": "serious"
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                    },
                    {
                        "exact_snippets": "bone fracture",
                        "criterion": "bone fracture",
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                            "requirement_type": "healing status",
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                        }
                    },
                    {
                        "exact_snippets": "bone fracture",
                        "criterion": "bone fracture",
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                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serious non-healing wound",
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                                    "requirement_type": "healing status",
                                    "expected_value": "non-healing"
                                }
                            },
                            {
                                "exact_snippets": "Serious non-healing wound",
                                "criterion": "wound",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "serious"
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                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "ulcer",
                                "criterion": "ulcer",
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                                    "requirement_type": "healing status",
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                                }
                            },
                            {
                                "exact_snippets": "ulcer",
                                "criterion": "ulcer",
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                                    "requirement_type": "severity",
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                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "bone fracture",
                                "criterion": "bone fracture",
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                                    "requirement_type": "healing status",
                                    "expected_value": "non-healing"
                                }
                            },
                            {
                                "exact_snippets": "bone fracture",
                                "criterion": "bone fracture",
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                                    "requirement_type": "severity",
                                    "expected_value": "serious"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evidence or history of bleeding diathesis or coagulopathy",
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                    {
                        "exact_snippets": "Evidence or history of bleeding diathesis",
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                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evidence or history of ... coagulopathy",
                        "criterion": "coagulopathy",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Evidence or history of bleeding diathesis",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Evidence or history of ... coagulopathy",
                        "criterion": "coagulopathy",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.",
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                    {
                        "exact_snippets": "Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.",
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                            "requirement_type": "time since occurrence",
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                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.",
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                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "and_criteria": [
                            {
                                "exact_snippets": "Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.",
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                                    "requirement_type": "time since occurrence",
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                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
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                                }
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                        ]
                    },
                    {
                        "and_criteria": [
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                                "exact_snippets": "Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.",
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                                    "requirement_type": "time since occurrence",
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                                        "operator": "<=",
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                        ]
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                    {
                        "and_criteria": [
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                                "exact_snippets": "Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.",
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                                    "requirement_type": "time since occurrence",
                                    "expected_value": {
                                        "operator": "<=",
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                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known or suspected allergy to sorafenib or any agent given in the course of this trial.",
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                    {
                        "exact_snippets": "Known or suspected allergy to sorafenib",
                        "criterion": "allergy to sorafenib",
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                            "requirement_type": "presence",
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                    },
                    {
                        "exact_snippets": "allergy to ... any agent given in the course of this trial",
                        "criterion": "allergy to trial agents",
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                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Known or suspected allergy to sorafenib",
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                            "requirement_type": "presence",
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                    },
                    {
                        "exact_snippets": "allergy to ... any agent given in the course of this trial",
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any condition that impairs patient's ability to swallow whole pills.",
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                    {
                        "exact_snippets": "condition that impairs patient's ability to swallow whole pills",
                        "criterion": "ability to swallow whole pills",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "condition that impairs patient's ability to swallow whole pills",
                    "criterion": "ability to swallow whole pills",
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                        "requirement_type": "impairment",
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                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any significant malabsorption problem.",
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                    {
                        "exact_snippets": "Any significant malabsorption problem.",
                        "criterion": "malabsorption problem",
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                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Any significant malabsorption problem.",
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                        "requirement_type": "severity",
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                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Therapy with bevacizumab < 3 months prior to first dose of study drug.",
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                    {
                        "exact_snippets": "Therapy with bevacizumab < 3 months prior to first dose of study drug.",
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                            "requirement_type": "time since last dose",
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                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Therapy with bevacizumab < 3 months prior to first dose of study drug.",
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                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Inclusion Criteria",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Exclusion Criteria",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "* Known HIV infection or chronic Hepatitis B or C.",
                "criterions": [
                    {
                        "exact_snippets": "Known HIV infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chronic Hepatitis B",
                        "criterion": "Hepatitis B",
                        "requirement": {
                            "requirement_type": "chronicity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chronic Hepatitis C",
                        "criterion": "Hepatitis C",
                        "requirement": {
                            "requirement_type": "chronicity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known HIV infection",
                        "criterion": "HIV infection",
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                            "requirement_type": "presence",
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                        }
                    },
                    {
                        "exact_snippets": "chronic Hepatitis B",
                        "criterion": "Hepatitis B",
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                            "requirement_type": "chronicity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chronic Hepatitis C",
                        "criterion": "Hepatitis C",
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                            "requirement_type": "chronicity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Use of St. John's Wort or rifampin",
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                    {
                        "exact_snippets": "Use of St. John's Wort",
                        "criterion": "St. John's Wort",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "use of ... rifampin",
                        "criterion": "rifampin",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Use of St. John's Wort",
                        "criterion": "St. John's Wort",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "use of ... rifampin",
                        "criterion": "rifampin",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* Measurable or non-measurable disease.",
                "criterions": [
                    {
                        "exact_snippets": "Measurable or non-measurable disease",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Measurable or non-measurable disease",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "measurable"
                        }
                    },
                    {
                        "exact_snippets": "Measurable or non-measurable disease",
                        "criterion": "disease measurability",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "non-measurable"
                        }
                    }
                ]
            }
        }
    ]
}